Thursday, June 28, 2007
Wednesday, June 27, 2007
- Reducing dietary energy density, particularly by combining increased fruit and vegetable intakes with decreased saturated fat intake, is an effective strategy for managing body weight while controlling hunger. Fruits and vegetables are water-rich foods that adds weight from water without adding energy and holding satiety.
- Snack chips fried with corn oil alleviate cardiovascular risk factors when substituted for low-fat or high fat snacks. We mentioned this study because even the most inane, skewed studies can appear in prestigious journals. This study was, of course, funded by Frito-Lay!
- Healthy men either consumed a high-fat, low carbohydrate diet (40% and 45%) or a low-fat, high carbohydrate diet (20% and 65%) to see how it would effect Lp(a) and triglycerides, both crucial cardiovascular risk markers. Only the low-fat, high carbohydrate diet increased these markers, showing that excess carbohydrate consumption (especially grains), exacerbates cardiac inflammation.
- Cinnamon reduces blood glucose and delays gastric emptying without affecting satiety.
- In two studies, a high intake of fresh fruit, root vegetables, and fruiting vegetables was associated with reduced mortality and lower blood pressure while aging, most likely as a result of antioxidants such as vitamin's C & A.
Tuesday, June 26, 2007
Italian researchers published a new study last week that showed aspartame -- widely used in soft drinks -- might cause leukemia, lymphoma and breast cancer in rats, but the FDA said there was no immediate need to take action.
"This is the second study by the same lab showing that aspartame causes cancer in rats," Center for Science in the Public Interest executive director Michael Jacobson said in a telephone interview.
"On the basis of the present findings, we believe that a review of the current regulations governing the use of aspartame cannot be delayed," researchers wrote in the journal Environmental Health Perspectives, which is published by the U.S. National Institute of Environmental Health Sciences.
"This review is particularly urgent with regard to aspartame-containing beverages, heavily consumed by children."
FDA spokesman Michael Herndon said the agency had not yet reviewed the study.
"However, the conclusions from this second European Ramazzini Foundation are not consistent with those from the large number of studies on aspartame that have been evaluated by FDA, including five previously conducted negative chronic carcinogenicity studies," Herndon said in an e-mail.
"Therefore, at this time, FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food."
Jacobson said people should avoid the product for now.
"People shouldn't panic, but they should stop buying beverages and foods containing aspartame," he advised.
Bonnie - we are not surprised by the FDA's response. They are in hot water with this.The previous studies the FDA refers to were all done by the manufacturer of aspartame and severely flawed. This is the first legitimate study executed on rats or humans. For further info, click on last week's blog entry on the issue.
As of 6/28/07, the FDA altered its response slightly: "FDA is interested in reviewing the recently published study; however, to date FDA has not been provided the data from this new study. Until FDA conducts an evaluation of the study, it cannot comment on the findings."
In the study, those who most often experience negative emotions such as depression and anxiety were 40 percent more likely to develop mild cognitive impairment than those who were least prone to negative emotions. Mild cognitive impairment is a transitional stage between normal aging and dementia. People with mild cognitive impairment have mild memory or cognitive problems, but have no significant disability. Researchers analyzed the results from two larger studies, the Religious Orders Study and the Memory and Aging Project. The studies involved 1,256 people with no cognitive impairment. During up to 12 years of follow-up, 482 people developed mild cognitive impairment.
Participants were evaluated on their level of proneness to distress and negative emotions by rating their level of agreement with statements such as "I am not a worrier," "I often feel tense and jittery," and "I often get angry at the way people treat me." "People differ in how they tend to experience and deal with negative emotions and psychological distress, and the way people respond tends to stay the same throughout their adult lives," said study author Robert S. Wilson, PhD, of Rush University Medical Center in Chicago, IL. "These findings suggest that, over a lifetime, chronic experience of stress affects the area of the brain that governs stress response. Unfortunately, that part of the brain also regulates memory."
An earlier study by Wilson and his colleagues showed that people who are easily distressed are more likely to develop Alzheimer's disease than more easygoing people. Wilson said several factors lead researchers to believe that proneness to stress is a risk factor for memory problems and not an early sign of disease. The study was supported by grants from the National Institute on Aging and the Illinois Department of Public Health.
Bonnie - this data further heeds the call for taking stress management seriously and creating an environment of positive thinking!
Belgian Endive - one head provides 222% of daily vitamin A requirement, 56% vitamin C, 27% calcium, and 24% iron;
Butterhead - one head provides 108% of daily vitamin A requirement and 11% iron;
Cabbage - one head provides 761% of daily vitamin C requirement, 50% calcium, and 33% iron;
Iceberg - one head provides 76% daily vitamin A requirement, 35% vitamin C, 14% calcium, and 17% iron;
Spinach - one head provides 638% of daily vitamin A requirement, 159% vitamin C, 51% iron, and 34% calcium;
Romaine - one head provides 727% of daily vitamin A requirement, 250% vitamin C, 34% iron, and 21% calcium;
- Massage - helps with pain
- Acupuncture - helps reduce nausea
- Yoga - helps with fatigue
- Diet & Nutrients - helps with all of the above
Monday, June 25, 2007
Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, companies that manufacture, pack, label or hold dietary supplements have been required to conform to conventional food cGMP. Dietary Supplements now have their own set of standards.
We found several specifics in this ruling that warrant discussion:
-The final rule goes into effect one year from publication date for large companies (defined as 500 or more employees) and two years from publication for small companies (defined as less than 500 employees) and very small companies (defined as less than 20 employees) will have three years.
NCI: we are disappointed with the length of time the smaller companies have to conform. In our view, they should have been adhering closely to the standards for medications already, which are even more stringent than these cGMPs.
-The rule is relevant to all dietary supplements sold or offered for sale in the United States, so that even foreign firms will be required to meet the new manufacturing identification standards.
NCI: this is fine. Manufacturers must identify every ingredient with 100% certainty. However, this still leaves it up to the manufacturer to create its own quality control measures to ensure the safety of raw materials. Raw material suppliers are exempt from these cGMPs. There is a lot left to be desired from raw materials coming from abroad. The adverse reaction reporting system that was passed earlier this year will help with safety, but a set of ironclad safety guidelines for all to follow could have been placed in this ruling. Now, instead of acting as a preventive, safety will still be reactive.
-FDA will "exercise enforcement discretion" with regard to products made by practitioners, such as acupuncturists and herbalists who use the products that they make in a "one-on-one consultation."
NCI: we are very encouraged by this development. There is very little attention paid to supplements manufactured by practitioners, pharmacies, and custom vitamin formulators. However, oversight of this regulation will take a "Herculean" effort.
-Requires a qualified person to investigate any ''product complaint'' that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.
NCI: Once again, noble, but impossible to enforce in the FDA's current state. Look at the deplorable track record they have had with addressing food and drug infractions/safety.
A colleague was on the FDA press conference call the day the cGMPs were released, and he asked if the agency currently has the resources and personnel to effectively enforce the GMP requirements.
The answer was that this will become a part of the agencies overall enforcement strategy which bases resource allocation on potential risk.
When he asked what level of risk the agency believes exists in the dietary supplement sector, the response was that the agency does not really know yet.
We've been saying it all along, but will say it again. If the agency does not enforce the cGMPs, then this will only make the playing field even more unlevel. And we have serious doubts that this will be accomplished.
Another crucial issue that was not addressed in this ruling: there are still no regulations that require supplements to carry adequate directions for use and appropriate warnings.
If you read this newsletter, most likely you have put your nutritional care in the hands of Nutritional Concepts. Why should this put you at ease?
- 25 years of clinical and public health experience with nutritional supplements.
- Many manufacturers that we work with adhere to the cGMPs required of drug manufacturers, which exceeds the new cGMPs set for the dietary supplement industry.
- Having prescribed the same dietary supplements for 10 to 20 years, a track record of safety and reliability has been established.
- We go beyond the cGMPs and ask our manufacturers to provide us with data on their raw material suppliers. We do this to confirm that our manufacturers are consistently checking their raw materials for impurities, toxins, and place of origin.
- Your nutrient needs have been individualized to your unique needs, going far beyond any recommendations that could be made on a label or by a store employee.
No one was told to make big lifestyle changes, such as exercising more or less. Of those who used the plate for six months, 17 percent lost 5 percent or more of their weight, an amount considered clinically important because it cuts risks of obesity-related conditions like heart disease and cancer, Pedersen said. In the group that didn't use the plate, fewer than one person in 20 lost a clinically important amount. More than a quarter of the plate users could reduce their diabetic medication, versus 11 percent in the other group, according to the study. In addition, 34 percent of those who did not use the Diet Plate had to increase their drug intake. "That's important, because if we can, with better diet control, get someone down on their medication, that means there is less potential for side-effects related to medication and the cost of medication," she said.
Steve - this is encouraging while not surprising. Our version of the Diet Plate, The Circle of Health, mirrors the size of a dinner plate and exhibits ideal dietary balance. Many of our clients lose more weight in six months than what is shown in this study and our plate is even more colorful.
Better yet, echinacea might reduce the length of a cold by an average of 1.4 days -- a substantial savings, because colds cause 40 percent of the nation's lost work time, the authors of a recent study say.
The study, conducted by scientists from the University of Connecticut, is published online today in The Lancet Infectious Diseases, a British medical journal.
Over the years, studies of echinacea have shown "a trend of improving colds," but none involved enough patients to be statistically significant, said the author of today's article, Dr. Craig Coleman of the University of Connecticut's School of Pharmacy.
Other studies have shown just the opposite. In 2000, German scientists reported that echinacea could help treat colds but not necessarily prevent them. In 2005, a study of more than 400 patients published in the New England Journal of Medicine indicated that echinacea had no effect on colds at all.
Coleman's team performed a meta-analysis, combining the results of 14 independent studies involving more than 1,600 patients.
Some experts say that's still not good enough. They argue that Coleman's meta-analysis combines too many studies with different combinations of drugs.
"Some of the patients were also taking Vitamin C, rosemary, thyme ... you really don't know what's going on," said Dr. Adriane Fugh-Berman, associate professor of complementary and alternative medicine at Georgetown University.
To compensate for this problem, Coleman said, his team did a "sensitivity analysis" to determine whether echinacea worked on its own.
"There was still reduction in cold duration," Coleman said, but not enough to be statistically significant.
Steve - we treat meta-analysis of dietary supplements exactly as we do medications...very cautiously. This means that we are not going to blanketly start recommending echinacea just because of this review study. Echinacea has and always will be a mixed bag. It is low on the totem pole of our recommendations for immune boosters.
While some benefit from its positive effect on immune function, others do not. How one responds to echinacea, we believe, is due to one's genetic makeup. In addition, echinacea contraindicates with other herbs and some medications. We also never recommend taking it for more than two weeks at a time.
The Advertising Standards Authority of South Africa made the ruling this week in response to a consumer complaint lodged against a Monsanto South Africa print ad referring to GM grain products.
The ad, which ran in the February edition of You magazine, carried the heading: "Is your food SAFE?" and contained an image of a woman with two children in a kitchen looking at a cake.
Below the sub-heading: "Biotechnology - the true facts" it said: "This is one of the most extensively tested and controlled types of food, and no negative reactions have ever been reported."
The ASA said that the onus was now on Monsanto to provide independent verification of the "no negative reactions" claim.
Steve - I am looking forward to seeing this independent verification :)
Friday, June 22, 2007
What we can say is this is a great step in the right direction. However, tracking those unsavory manufactureres who do not comply will be a tall order as we have seen so many times with their handling of medication safety and GMPs.
Lyrica was approved for fibromyalgia following clinical trials involving about 1,800 people, although not all participants were helped by the drug, the agency said. Lyrica, manufactured by Pfizer, Inc., is already approved to treat partial seizures, and pain from shingles and diabetic neuropathy. Lyrica's main action affects the central nervous system.
What are the possible side effects of LYRICA?
• dizziness and sleepiness.
• eyesight problems.
• weight gain and swelling of the hands and feet (edema).
Weight gain may affect the management of diabetes. Weight
gain and swelling can also be a serious problem for people with
• unexplained muscle problems, such as muscle pain,
soreness, or weakness. If you develop these symptoms,
especially if you also feel sick and have a fever, tell your
doctor right away.
The most common side effects of LYRICA are:
• blurry vision
• weight gain
• trouble concentrating
• swelling of hands and feet
• dry mouth
LYRICA caused skin sores in animals. Although skin sores were not seen in studies in people, if you have diabetes, you should pay extra attention to your skin while taking LYRICA and tell your doctor of any sores or skin problems.
LYRICA may cause some people to feel “high.” Tell your doctor, if you have abused prescription medicines, street drugs, or alcohol in the past.
These are not all the side effects of LYRICA. For more information, ask your doctor or pharmacist.
What are the ingredients In LYRICA?
Active ingredient: pregabalin
Inactive ingredients: lactose monohydrate, cornstarch, talc;
Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.
Thursday, June 21, 2007
And based on the "exponential growth" of farmers' markets, as well as retail and foodservice initiatives to add more local products to their merchandise mix and menus, Packaged Facts estimates that locally grown foods could turn into a $7bn business by 2011.
The report defines 'fresh foods' as anything that requires refrigeration or has a short shelf life. 'Locally grown foods' are those that need to travel no more that one day from their point of production to their point of purchase.
According to Packaged Facts, consumers equate locally grown food with freshness, and freshness with higher quality. As a result, they are increasingly looking toward the perimeter departments of supermarkets for fresh foods that include locally grown and organic fruits and vegetables, fresh meats, seafood, dairy and baked goods.
Consumers are also turning to these products as they are increasingly concerned about the impact of businesses on the environment, which prompts a desire for 'greener' purchases. Another concern is a loss of confidence in the conventional food safety systems, which turns some people away from a reliance on a heavily industrialized food chain.
"New trends, including 'food miles', 'the Slow Food movement', and even 'locavores' who eat only locally grown foods, are just beginning to take root in the US and we anticipate these and other trends will swiftly drive growth of local and fresh market foods," said Don Montuori, the publisher of Packaged Facts.
Steve - all we can say is...YEAH!
It has made it onto the sweetener aisle shelves of Kroger, Schnucks, Brookshire and Albertsons, sitting right next to the top three artificial sweetener products in the world.
There have been rumors that the US Food and Drug Administration (FDA) could be petitioned to approve stevia as a food additive.
Public awareness of the ingredient shot up earlier this month, after the Wall Street Journal revealed that big players Coca-Cola and Cargill were teaming up to market a stevia sweetener product. Coca-Cola has filed 24 patent applications for the ingredient in the US.
According to the article, the two firms are gathering data on the ingredient in order to apply for FDA approval.
The full text of the article is available online at: http://www.ehponline.org/docs/2007/10271/abstract.html
Environmental Health Perspectives (EHP), the peer-reviewed journal of the United States' National Institute of Environmental Health Sciences, is an important vehicle for the dissemination of environmental health information and research findings. EHP's mission is to serve as a forum for the discussion of the interrelationships between the environment and human health by publishing in a balanced and objective manner the best peer-reviewed research and most current and credible news of the field. With an impact factor of 5.34, EHP ranks first among 132 environmental sciences journals and first among 90 public, environmental, and occupational health journals. EHP is read in over 190 countries.
Background. In a previous study conducted at the Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation (CMCRC/ERF), we demonstrated for the first time that aspartame (APM), administered with feed at various doses to 8 week-old Sprague Dawley rats for the lifespan, is a multipotent carcinogenic agent.
Objective. The aim of this second study is to better quantify the carcinogenic risk of APM, beginning treatment during fetal life.
Methods. The study was conducted on groups of 70-95 male and female Sprague Dawley rats, administered APM with feed at concentrations of 2000, 400, or 0 ppm from the 12th day of fetal life until natural death.
Results. The results of the study show: a) a significant dose-related increase of malignant tumor-bearing animals in males, in particular in the group treated at 2000 ppm; b) a significant increase of the incidence in lymphomas/leukemias in males treated at 2000 ppm and a significant dose-related increase of the incidence of lymphomas/leukemias in females, in particular in the group treated at 2000 ppm; c) a significant dose-related increase of the incidence of mammary cancer in females, in particular in the group treated at 2000 ppm.
Conclusions. The results of this carcinogenicity bioassay not only confirm, but also reinforce the first experimental demonstration of APM’s multipotential carcinogenicity at a dose level close to the acceptable daily intake (ADI) for humans. Furthermore, the study demonstrates that when lifespan exposure to APM begins during fetal life, its carcinogenic effects are increased.
Link to first Ramazzini APM study (Environ Health Perspect 114:379-385, 2006): First Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats
Steve - we have followed this very closely over the years. The fact that Cargill and Coca Cola are venturing into the world of stevia says a lot about where aspartame is headed. As we have said forever, aspartame is poison. The public at large will be privy to this soon enough.
Wednesday, June 20, 2007
Consumers will have to pay slightly more for the privilege though. Dave Hogberg, a senior vice president at Tyson, declined to specify how much of an increase shoppers would see at stores, but he said it would be “below the cost consumers say they’re willing to pay.” He said that Tyson was converting 20 — not quite half — of its production facilities to produce the products. Mr. Bond said the switch would not affect the company’s earnings in the short term and could increase demand for chicken.
Courtesy of Associated Press
Steve - in 2002, it was reported in the NY Times that Tyson only used antibiotics when a flock was at risk for a disease. Further study will have to be made to see if they were using antibiotics more widely than believed.
The study provides processors with a view of the dietary requirements of consumers of the future and the potential scale that a contamination problem involving allergy-triggering ingredients could have.
A "dramatic increase" in the number of children hospitalized as a result of anaphylaxis - the most severe and potentially deadly type of food allergy, was also found during the study, published this month.
Over a twelve year period, 1489 children aged between 0 and five years-old were referred to a specialist allergy practice in the Australian Capital Territory, of which found 697, or 47 per cent, suffered from a food allergy.
The specialist allergy practice in the Australian Capital Territory that conducted the study found the most common reactions were involved peanuts, eggs, cows milk and cashews.
During the study, the number of children tested at the clinic with suspected allergies rose four-fold from 55 in 1955 to 240 in 2006.
While the prevalence of non-food allergies, such as hay fever and asthma, experienced little change during the study, food allergies rose from 20 per cent of children tested in 1995 to 57.5 per cent by 2006.
While part of this increase could be attributed to an increasing understanding of the symptoms of allergies, improving parents' ability to spot what is a likely reaction to food, the marked increase demonstrates a trend towards intolerance towards certain foods.
Bonnie - as we know full well, this dramatic rise is not limited to Australia. However, Australian's dietary habits are similar to ours. As long as wheat, milk, corn, and soy are in everything we eat, food intolerance/allergy will continue to rise.
Tuesday, June 19, 2007
Researchers began their investigation by conducting a series of neurological and memory tests on each subject, who ranged in age from 52-70, with either a history of memory complaints or a diagnosis of mild cognitive impairment. Single Photon Emission Computed Tomography (SPECT) scans, a brain imaging technique which measures cerebral blood flow, were also conducted on each subject. Following the initial tests, subjects were taught the techniques of Kirtan Kriya, the most widely practiced meditation in the Kundalini Yoga tradition, and instructed to practice a 12-minute meditation each day for eight weeks.
While follow up testing confirmed statistically significant improvements in memory among all of the study's subjects, the most significant outcome of the study was the stark contrast between the pre and post-training SPECT scans. Follow up scans showed dramatic increases in blood flow to the posterior cingulate gyrus, the region of the brain associated with learning and memory. It is the first region of the brain to decline in individuals diagnosed with Alzheimer’s disease, which helps to explain why the blood flow-producing meditation has such a profound impact on cognitive functioning.
Friday, June 15, 2007
The nation's largest brewer said Wednesday that because of inaction on proposed regulations by the U.S. Department of Agriculture, it had started using 100% organic hops in its two beers that carry the "USDA Organic" seal. Previously, less than 10% of the beers' hops were organic.
"We have now begun brewing our nationally available organic beers with 100% organic hops, although at this time we have a limited amount of organic hops available," Doug Muhleman, vice president of brewing operations for Anheuser-Busch, said.
Food makers have been awaiting USDA approval of a list of 38 nonorganic ingredients, including hops, that could be allowed in organic products. Permission to use some nonorganic ingredients in organic foods expired Saturday, leaving many organic food makers uncertain on what to do.
"Since the deadline passed, Anheuser-Busch has not received any communications from the USDA regarding the reason for the delay," Muhleman said.
George Siemon, chief executive of Organic Valley Family of Farms in LaFarge, Wis., said Tuesday that he had organic sausage and bacon that could spoil unless the USDA acts soon.
"It's so grossly unfair, and it's just like we got dropped off a cliff," Siemon said. "We don't know what's going on."
The USDA's National Organic Program sent an e-mail to its certifying agents Friday, emphasizing that organic foods produced after that day could not use nonorganic ingredients that had previously been allowed under a misinterpretation of federal law.
"There is no provision for a grace period for this requirement; all products must be in compliance," said the e-mail from Mark A. Bradley, associate deputy administrator.
Regarding the ingredients under review, Bradley said, "We are doing our best to work these materials through the regulatory process as quickly as possible."
Although most organic food manufacturers have supported the move to allow use of the 38 ingredients, many consumers have protested what they perceive as a watering down of the organic label. The National Organic Program received more than 1,000 complaints about the proposed rule during a one-week public comment period in May.
For food to be called organic, it must be grown without chemical fertilizers and pesticides. Animals must be raised without antibiotics and growth hormones and given some access to the outdoors.
Federal law requires products carrying the "USDA Organic" label to contain at least 95% organic ingredients. The other 5% can be nonorganic ingredients that have been placed on the USDA National List, provided that organic equivalents are not commercially available or available in sufficient quantity.
Courtesy of LA Times
Steve - this is one example of the USDA's ineptness helping our cause!
Thursday, June 14, 2007
"In this large population based cross-sectional study we found that daily use of cod liver oil was negatively associated with high levels of depressive symptoms and that the prevalence of such depressive symptoms decreased with the duration of cod liver oil use," wrote lead author Maria Baroy Raeder from Haukeland University Hospital
Baroy Raeder and co-workers used data from the population based cross-sectional health survey "The Hordaland Health Study '97-'99" (HUSK), and report that 8.9 per cent of subjects used cod liver oil daily.
"The users of cod liver oil were significantly less likely to have depressive symptoms than non-users after adjusting for multiple possible confounding factors (29 per cent reduction)," wrote the researchers.
They also report that length of regular cod liver oil supplementation was found to influence the prevalence of high levels of depressive symptoms - the longer the duration of supplementation, the lower the prevalence of symptoms of depression.
The study does have several limitations, most notably the lack of dietary data that could have affected the results. In addition, socio-economic factors were not accounted for in the study, which also may affect the overall health and mental state of the subjects. The researchers, therefore, stressed that the results should be interpreted with care.
"To confirm such a possible protective effect, randomized controlled trials are needed," concluded the researchers.
Bonnie - limitations on this study, yes. However, it was such a large population study and was done in a country with very little yearly sun exposure. It confirms what we have been saying: the combination of omega-3's and vitamin D for mood is dynamite!
Wednesday, June 13, 2007
Federal health advisers unanimously rejected a weight-loss drug after hearing testimony that it increases the risk of suicidal behavior. The manufacturer, Sanofi-Aventis SA, failed to show the drug rimonabant is safe, the panel said. The unanimous finding by the expert panel's 14 voting members made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.
"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, of The Rockfeller University. In studies, patients given the once-daily tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received sham treatment, Dr. Amy Egan, a FDA medical officer told federal health advisers. "The numbers of events are small, but in aggregate they are worrisome," Egan said.
The FDA is to make a final decision on the drug by July 27. The company proposes selling the drug under the brand name Zimulti. Rimonabant already is sold in Europe as Acomplia. The litany of mental problems associated with the drug clearly gave the panelists pause. "I think this is a drug that needs further understanding with respect to what it does to people's psyche," said panelist Dr. Sid Gilman, a University of Michigan neurologist.
"We strongly believe that it is causal," Egan said. She noted 88 percent of those reporting psychiatric problems while on the drug had no prior history of depression. Furthermore, patients in the studies were carefully screened and monitored, suggesting the problems would be more common should the drug enter broad use, Egan added. The screenings proposed by the company won't keep the depressed and obese from Zimulti, warned Lynn McAfee, head of medical advocacy for the Council on Size & Weight Discrimination, a fat acceptance group. "If this gets out to be a real big deal in the public, you can figure out how to answer those questions to get the drug," McAfee said. "It's not going to stop anyone." The potential market for the drug is huge, as obesity rates have exploded in the past two decades. Today, nearly one in three American adults age 20 or older is obese, according to government data. Dr. Sidney Wolfe, of the advocacy group Public Citizen, said the obese are more likely to be depressed. Many of them likely would take Zimulti along with the antidepressants they already use — with unknown consequences, Wolfe told panelists. Rimonabant blocks the same pleasure centers in the body activated when pot smokers get the munchies. Blocking the receptors leads to patients eating less and losing weight.
Now - we wait and see what the FDA does. There will be a lot of pressure on them either way!
- a study of immense implications as far as reinforcing what we've been saying: randomly assigned adults with metabolic syndrome were given a low glycemic carbohydrate (rye-pasta) or high glycemic carbohydrate (oat-wheat-potato); the low glycemic carb decrease expression of genetic insulin (inflammatory) pathways while the high glycemic carbs increased expression of the same pathways
- a study showing the effectiveness of high-dose fish oil supplementation before heart surgery provides a foundation for further studies into the optimal use of fish oil as a preventive against life-threatening arrythmias that are prone to occur after heart attack; flaxseed and olive oil had no significant effect
- trace element supplementation (copper, selenium, zinc) was associated with higher circulating plasma and skin tissue contents of selenium and zinc and improved antioxidant status. These changes improved clinical outcome, including fewer pulmonary infections and better wound healing in burn patients
- older persons who consume inadequate dietary protein for one week experience a wide variety of changes that may precede accommodation, including inflammatory stress, reduced metabolism and oxygen transport, reduced protein synthesis, and muscle wasting
- a dietary pattern characterized by high meat and fat intakes increases squamous cell
carcinoma, a specific form of skin cancer, particularly in persons with skin cancer history
Professor Callard said: "Despite its popularity over the past 20 years there is very little supporting evidence for the "hygiene hypothesis". "In contrast, there is mounting evidence from both studies of rare genetic conditions and our lab work to support an important role for abnormalities in the outer protective layer of the skin in allowing allergic sensitization." Professor John Harper, who also worked on the study, said people had nothing to fear from normal standards of hygiene - the potential problem was over-zealous use of harsh cleaning products. He said: "Good standards of hygiene are clearly important to prevent spreading of unpleasant diseases. "But if this proposed mechanism does turn out to be true, we may be able to reduce the incidence of these diseases by developing new treatments which specifically target the outer protective layer of the skin."
Steve - there may be some validity to this study, but there are myriad reasons why allergies are on the rise. We need to look at our total lifestyles and pinpoint the areas that may be contributing to the inflammation, such as, diet, toxic load, living situation, stress level, and hygiene habits.
The new guidelines come after a literature review weighing the effectiveness of antibiotics against their possible risks, such as allergic reactions and the development of drug-resistant bacteria showed the risks outweighed the benefits for most patients.
Bonnie - this is a long time comng and very good to hear.
Mothers are also aid to be less at risk of post partum depression or mood change, and to recover more quickly after pregnancy, if they consume enough of the fatty acid.
Writing in the American Journal of Clinical Nutrition, researchers from the University of Connecticut and Carol Lammi-Keefe from Louisiana State University state that this is the first study to look at the effect of DHA supplementation during pregnancy on the problem solving ability of the infant during the first year of life.
The researchers recruited 29 pregnant women at gestation week 24 and randomly assigned them to receive either a daily DHA-containing cereal-based bars (300 mg DHA/92-kcal bar) or cereal-based placebo bars. The women consumed an average of five bars per week.
Once the infants had reached nine months of age, they were tested using The Infant Planning Test and Fagan Test of Infant Intelligence. Children of mothers supplemented with the DHA-containing functional food had significantly better performance for problem-solving, while no significant differences between the groups was observed in overall intelligence.
Tuesday, June 12, 2007
Steve was noticed for his excellent work on our blog, newsletter, website, and client/public relations. Well done, Steve!
Monday, June 11, 2007
Follow-up exams revealed increased blood levels of CoQ10, and more importantly, the frequency of headaches and headache disability scores were reduced by half.
Research has shown similar results in adults.
Acomplia is sold in several European countries and Sanofi-Aventis, Paris, is seeking approval to sell the drug in the U.S.
Acomplia, which would be sold under the brand name Zimulti in the U.S., faces a review Wednesday by an FDA panel of outside medical experts. The FDA typically follows its panels' advice, but isn't required to do so. The FDA is set to make a final decision on whether to approve the drug by the end of July.
In briefing documents posted to its Web site Monday, the FDA said the 20-milligram dose of Acomplia was "associated with statistically and clinically significant weight loss." However, the FDA said it was concerned about an increase in psychiatric side effects as well as seizures. Sanofi had studied a 5- and a 20-milligram dose. The FDA said the 5-milligram dose wasn't effective at helping people lose weight.
Sanofi is seeking FDA approval to sell a 20-milligram dose to people considered obese and to people who are overweight who have at least one cardiovascular disease risk factor such as high blood pressure. Studies of the drug typically showed patients on the drug lost about 15 pounds over the course of a year while those in the placebo group lost about three pounds. They also had gains in HDL, or "good," cholesterol and declines in decline in triglyceride levels, or a type of fat found in the blood.
Acomplia is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.
The FDA reviewed clinical studies of the drug as well as post-marketing reports of the drug from Europe. The agency said the 20-milligram dose of Acomplia "statistically, significantly increased suicidality" compared to placebo or a fake drug. Suicidality is a term used to describe an increase in suicidal thoughts and behaviors and doesn't refer to completed suicides.
The agency also said there was a higher rate of other psychiatric side effects among Acomplia users and the drug increased the risk of seizures. The agency said one set of studies showed 26% of patients on the 20-milligram dose of Acomplia reported a psychiatric side effect -- ranging from depression to insomnia -- compared to 14% of patients in the placebo group.
In its briefing document, Sanofi said the "overall benefits in body weight, waist circumference and metabolic parameters...outweigh the risks that are manageable in clinical practice." The company said it would recommend that Acomplia not be used in patients with an existing psychiatric disorder like major depression and that the drug be used "cautiously" in patients with epilepsy, which causes seizures.
Last February, the FDA rejected Acomplia as a smoking-cessation product and said it needed more information on psychiatric side effects before it would consider approving the drug as a weight-loss treatment.
Courtesy of The Wall Street Journal
Steve - this concurs with what we said in our April issue of Bonnie's Special Report.
The psychiatric side effects that accompany this drug may have been the "unknown" factor causing a 50% dropout rate in short-term trials. Of those left in the trials, there were still a statistically significant number of subjects who experienced severe mental side effects.
Given the fact that the drug does affect the neurological system, we should not be surprised by this.
We are anxiously awaiting the recommendations from Wednesday's panel. Billions are riding on this drug.
Many nonorganic ingredients, including hops, are already being used in organic products, thanks to a USDA interpretation of the Organic Foods Protection Act of 1990: manufacturers can use nonorganic ingredients only if organic versions are not "commercially available." Food makers have found a way around this barrier, in part because the USDA doesn't enforce the rule directly. Instead, it depends on its certifying agents — 96 licensed organizations in the U.S. and overseas — to decide for themselves what it means for a product to be available in organic form. Despite years of discussion, the USDA has yet to provide certifiers with standardized guidelines for enforcing this rule.
"There is no effective mechanism for identifying a lack of organic ingredients," complained executives of Pennsylvania Certified Organic, a nonprofit certifying agent, in a letter to the USDA. "It is a very challenging task to 'prove a negative' regarding the organic supply."
In 2005, a federal judge disagreed with how the USDA was applying the law and gave the agency two years to revise its rules.
Organic food supporters had hoped that the USDA would allow only a small number of substances, but were dismayed last month when the agency released the proposed list of 38 ingredients.
"Adding 38 new ingredients is not just a concession by the USDA, it is a major blow to the organic movement in the U.S. because it would erode consumer confidence in organic standards," said Carl Chamberlain, a research assistant with the Pesticide Education Project in Raleigh, N.C.
In addition to hops, the list includes 19 food colorings, two starches, casings for sausages and hot dogs, fish oil, chipotle chili pepper, gelatin and a host of obscure ingredients.
Large companies have a better chance of winning approval to use nonorganic ingredients because the amount they demand can exceed the small supply of organic equivalents, said Craig Minowa, environmental scientist for the Organic Consumers Assn.
Steve - of the 38 nonorganic ingredients, these are the only 4 we have an issue with:
Casings, from processed intestines (no CAS ) for use in meet products. The justification for adding non-organic casings to the National List is based upon insufficient availability of processed intestines from organically produced animals.
Gelatin is used as a stabilizer, thickener, or texturizer in a variety of foods. The NOSB recommended adding gelatin to the National List for use in organic handling as a non-organic agricultural ingredient where the organic form of gelatin is considered commercially unavailable.
Hops was petitioned for use as a non- organic agricultural ingredient in or on processed products labeled as ``organic.'' Hops are a primary ingredient used in brewing beer. Due to these unique characteristics that are contributed to a specific brewing process, brewers cannot interchange hop varieties should a selected variety be commercially unavailable without significant changes in the final product.
Whey protein concentrations of 35% and 80% was petitioned for use as a non-organic agricultural ingredient in or on processed products labeled as ``organic.'' Organic cheese manufacturers reportedly divert whey by-product to more lucrative markets than currently exist with the manufacture of whey protein concentrate, thus availability of whey by-product from organic cheese processing is considered to be very limited.
Friday, June 08, 2007
The non-profit organization is jointly funded by UK farmers and processors and its mission is to promote awareness on scientifically based information on dairy. Thursday's conference at King's College London saw nutritional information presented to over 200 delegates including health professionals.
The underlying motivation behind the conference was to combat misinformation surrounding diary and present research showing how it can enhance a healthy diet.
"We want to give information on dairy as part of a healthy and well-balanced diet," Dairy Council director Judith Bryans said. "And that's why the theme of the conference was diet and health rather then diet and dairy."
The dairy council wants to show consumers that dairy has a whole range of potential health supporting applications.
"Dairy foods have a lot going for them, but people tend to think of only calcium and dairy," said Bryan. "There's a lot more than that."
Topics were listed under the broad banners of diet and bone health, nutrition and colon cancer, trans fatty acids and health, and diet and dental health. However, dairy did surface within these topics because of its nutrient content.
For instance, Creighton University's Professor Robert Heaney spoke on osteoporosis prevention and nutrients that can be derived from many sources, such as milk.
"Calcium was the first to be recognized as critical, but it is now becoming clear that vitamin D, Protein, phosphorus, zinc, magnesium, copper, and vitamins C and K, are also needed," said Heaney. "Dairy foods are a principal dietary source for a host of these nutrients, which are needed for health."
The presentation on diet and weight control looked at calcium's potential health-supporting role for weight loss.
This topic has proved controversial in the US, where the US Department of Agriculture (USDA) and the nation's dairy industry were recently obliged to stop making claims in their advertising that dairy products cause weight loss.
"The important thing for us was to engage with these health professionals so that they can take this information and the new messages back to their practices," said researchers.
Steve - the Dairy Council is very worried that milk is fading as the bane of dietary existence. The need to rampu up the propaganda machine.
After examining data from the Alpha-Tocopherol, Beta-Carotene (ATBC) Cancer Prevention Study, Panagiota Mitrou and colleagues from the National Cancer Institute, Rockville, Maryland concluded that there was a link between calcium consumption and prostate cancer risk.
"We found a strong, graded, positive association between calcium intake and total prostate cancer risk," said the researchers.
They claimed that after adjusting the data for potentially influential variables, the risk of prostate cancer was 63 per cent greater for men who consumed 2,000 milligrams per day or more of calcium compared with those who consumed less than 1,000 milligrams per day.
The ATBC study examined the eating habits of 27,028 Finnish male smokers between the ages of 50 and 69 years old.
During 17 years of follow-up, the team identified 1,267 cases of prostate cancer.
Source: International Journal of Cancer
Bonnie - this would make sense. First, men do not need a lot of calcium. In Finland, they consume a ton of dairy products. Fins have very little sun exposure, and I would venture to say that they are vitamin D-deficient as a population. Hence, the potential for cancer would be more prevalent, especially with vitamin D's potential cancer prevention properties.
In addition, the rate of osteoporosis and heart disease are very high in Finland, which is once again, an immense consumer of dairy products.
Bonnie - just like we cannot get excited about a medication that shows great results in a small study, the same applies in this case.
The skin makes vitamin D when exposed to sunlight's ultraviolet rays. This study used that same form of the vitamin, known as D3 or cholecalciferol. Multivitamins usually carry a much weaker variant known as D2, but D3 is available in stand-alone dietary supplements.
Bonnie - any multivitamin worth its salt contains vitamin D3.
This study, published Friday in the American Journal of Clinical Nutrition, is the first time that researchers significantly boosted — and measured — blood levels of vitamin D and then followed identical groups of patients from start to finish. That's why, despite its modest size, the research was generating excitement. Nearly all other work has compared disparate groups of patients. The researchers at Creighton University in Omaha focused on 1,179 seemingly healthy women with an average age of 67. The women were divided into three groups: 446 got calcium and vitamin D3 supplements, a similar number got calcium alone, and 288 took dummy pills. The research team gave 1,000 daily international units of vitamin D, more than current guidelines calling for 200 to 600 units depending on a person's age. The researchers intended to check mainly for the effects of calcium on bone health. Their interest in cancer risk was secondary. But the lower cancer risk stood out. Only 13 women, or 3 percent, developed cancer over four years of calcium and vitamin D supplements. With calcium alone, 17 women, or 4 percent, got cancer. With dummy pills, cancer appeared in 20 women, or 7 percent. That shows a 60 percent lower cancer risk over four years in the group taking both supplements, compared to patients taking placebos. And when the first-year cancers were excluded — the ones mostly likely present before the study began — the findings were stronger still: a 77 percent lower risk for the combo group. While the calcium-only group lowered its four-year cancer risk by 47 percent compared to the untreated group, it did no better when early cancers were excluded. That suggests calcium alone may have done little in this experiment, the researchers said.
Bonnie - this is a good example of how calcium, to be properly allocated and utilized in the body, requires adequate vitamin D.
As with any nutrient, dosage varies based upon the individual and should be assessed by a licensed health professional.
Wednesday, June 06, 2007
A study published in the Journal of the American Medical Association (JAMA) suggests that folic acid supplementation does not reduce the risk of benign colorectal tumours and may even increase the risk of higher grade tumours.
I cannot say I am surprised.
1. When you structure a study for a nutrient the same as you would a drug, it is bound to fail. The subjects were 57 years or older who recently had at least one colorectal adenoma removed within three months of enrollment. Researchers were surprised to find more adenomas in the patients who had received folic acid although the risk did not differ significantly between the two groups.
The researchers said this study does not say anything about whether folic acid prevents adenomas in the first place, since all the patients had already had at least one when they were enrolled. It would cost a lot of money and take a long time, to prove that folic acid prevented tumours. "The question of efficacy of folate in cancer prevention is not resolved, and animal experiments showing chemopreventive effects of folate, as well as the strong observational epidemiological evidence, speak to the potential of folate as a chemopreventive agent, if taken early. Unfortunately, primary prevention trials that start in childhood would be lengthy, expensive, and logistically nearly impossible," said reseaarchers.
Bingo! Preventative studies take longer and are more costly.
2. In an accompanying editorial, Dr Cornelia M Ulrich and Dr John D Potter, from the Fred Hutchinson Cancer Research Center in Seattle, said that this study may be raising an issue of timing. If taken early, then perhaps folic acid prevents adenomas from forming, but if taken once they are formed, it could accelerate their development into cancer.
"The most likely explanation for the increased risk of advanced and multiple adenomas in the intervention group is that undetected early precursor lesions were present in the mucosa of these patients (who are at increased adenoma risk), and that folic acid promoted growth of these lesions," they wrote.
They may be right on both accounts. From a preventative standpoint, there is copious research showing the positive effects of folic acid (see below). With regard to folic acid causing more adenomas, this is yet another reason why you see a licensed health professional who is knowledgeable in prescribing dietary supplements.
The fatal flaw in the structure of this study is not recognizing the amount of vitamin B-12 that these subjects were taking, if at all. The fact that these subjects were given folic acid supplements without the aid of separate B-12 or in a multivitamin is an egregious error. Folic Acid and B-12 work harmoniously. B-12 is crucial to digestion, and folic acid in high doses can further reduce B-12 stores if not supplemented. For instance, in research done on seniors, those with low levels of B-12, even with high amount of folate, showed no improvement in mental acuity. However, with normal B-12 stores combined with high folate supplementation, seniors' mental acuity progresses.
3. Mandatory fortification of certain foods with folic acid was introduced in the US and Canada in 1998 in a bid to reduce the incidence of pregnancies affected by neural tube defects. The measure appears to have been a success, with NTD-affected pregnancies reported to have fallen by 26 per cent. Many other countries around the world have a similar program and have seen success. Here is the list of research studies that have appeared on our blog over the past year. Aside from the first two studies (which were performed on sick people, similar to the above adenoma study), all addressed prevention. Would you be surprised to know that these are all positive?
Folic acid won't cut heart risk in patients with history of heart ailments
In seniors with low vitamin B-12 status, high serum folate was associated with anemia and cognitive impairment. When vitamin B-12 status was normal, however, high serum folate was associated with protection against cognitive impairment.
Folic Acid found to cut risk of strokes
Folic acid may prevent hearing loss
Prenatal vitamins with folic acid reduces risk of childhood cancers Folic acid linked to reduced cleft lip in infants
Higher folate levels linked to Alzheimer's risk
Folate, B-6 could boost heart health for type-1 diabetics Folate may aid diabetics
Take folic acid to prevent heart disease
Folic acid may help fertility
Low dose folic acid could reduce homocysteine levels
Folic acid could reduce inflammation and prevent future inflammatory-related disease
Folic acid supplements may prevent cancer progression and promote regression of disease
Monday, June 04, 2007
The study looked at diet and its relation to blood pressure in 4,680 men and women, ages 40 to 59, who lived in Japan, China, Britain and the United States. They all provided in-depth details about their diets and alcohol consumption, gave urine samples and had their blood pressure measured twice at each of four study visits. Researchers then adjusted for 17 variables known to influence blood pressure such as age, gender, weight, salt intake and exercise. The people who ate diets rich in omega-3 fatty acids had slightly lower blood pressure, on average, than people who ate diets with less of the nutrient, the researchers reported in the American Heart Association Journal Circulation. "With blood pressure, every millimeter counts. The effect of each nutrient is apparently small but independent, so together they can add up to a substantial impact on blood pressure," said Dr. Hirotsugu Ueshima of Shiga University of Medical Science in Otsu, Japan. "If you can reduce blood pressure a few millimeters from eating less salt, losing a few pounds, avoiding heavy drinking, eating more vegetables, whole grains and fruits (for their fiber, minerals, vegetable protein and other nutrients) and getting more omega-3 fatty acids, then you've made a big difference," Ueshima said in a statement.
A spokeswoman said she could confirm reports about the existence of the sweetener, but was unable to give further details.
According to reports in the Wall Street Journal, Coca-Cola has filed 24 patent applications for the product, which has been tentatively named Rebiana. It plans to use the sweetener in some of its beverages.
It is believed that Cargill may also use the sweetener in some of its food products.
Stevia is only approved in the United States as a dietary supplement, not as a food additive. Therefore the first markets for the new sweetener could be outside the US.
The authorities in 12 countries have approved Stevia as a food additive, including Japan, Brazil and China.
However, Cargill is thought to be working on clinical trials of the sweetener and planning to use the results to petition the Food and Drug Adminstration (FDA) for permission to use rebiana as a food additive in the US.
Stevia is a member of the daisy family, and the extract is claimed by Steviainfo.com to be "the world's only all-natural sweetener with zero calories, zero carbohydrates and a zero glycemic index".
Extracts are said to have up to 300 times the sweetness of sugar. As a sweetener, stevia's taste has a slower onset and longer duration than that of sugar, although some of its extracts may have a bitter or liquorice-like aftertaste at high concentrations.
Most non-diet soft drinks in the United States are currently sweetened with high-fructose corn syrup, which has come under increasing criticism for contributing to obesity.
Lower-calorie sodas are made with artificial sweeteners such as saccharin, aspartame and sucralose. UK newspaper The Times has speculated that the development could be an indication that Tate & Lyle's sucralose is falling out of favour.
In its full year 2007 results, released last month, Tate & Lyle said that its Splenda sucralose brand had achieved only modest growth, which was disappointing.
A recent report by Freedonia revealed that the US sweetener market is poised to increase 4 percent per year, to reach over $1bn in 2010. A company that could offer a natural alternative to artificial sweeteners may have found the winning ticket to reaping the rewards of this growing market.
Steve & Bonnie - have we died and gone to heaven!!!!!!!!!!!! We are absolutely speechless. This is such an immense development. Cargill and Coca-Cola's involvement in promoting stevia will surely get it passed as a food additive in this country, setting the stage for our long-promoted, solely recommended sugar substitute to appear in products throughout the food spectrum.
Now...we know that the potential is there to mess this up whenever Big Food gets involved. We do not know what patents they are seeking. For instance, we don't know if they will mix other chemicals/sweeteners with stevia. We don't know if they will chemically alter the stevia itself, thus changing its natural state and creating adverse effects because of it.
Nevertheless, if they can take lead in getting this passed as a food additive, this will open up incredible opportunities for everyone and will go a long way to taking down alternative sweeteners such as Splenda, Equal, Sweet & Low, etc.