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Current Issues - Newsletter
February - March 2000

 
 
 

NEWS FLASH

 
 
   
  FDA revises position on dietary supplements during pregnancy  
 
  Further to the news item titled "Limits Eased on Dietary Supplements" (Current Issues, January 2000), we would like to inform our readers about a subsequent statement issued by the FDA on Feb. 9 advising dietary supplement manufacturers not to make any health claims related to pregnancy on their products. The FDA will issue a Federal Register notice shortly, describing the agency's concerns and plans for future action. The agency made the move after birth defect experts protested that the dietary supplements label claims for pregnancy-related conditions posed serious risks for pregnant women and their offspring.
 
   
 

More Secrets of Selenium Revealed

 
 
  In a Harvard School of Public Health study, men with the greatest selenium intake had a two-thirds lower risk of developing advanced prostate cancer over the next decade than those with the lowest selenium intake.

Family Practice News, November 13, 1998.

A government-sponsored trial, one of the largest ever conducted, will begin late this year to test whether commonly used antioxidants vitamin E and selenium can prevent prostate cancer, as reported by Reuters. The 12-year "SELECT" study, to involve 32,400 men at about 300 research centers in the United States and Canada, will be the biggest prevention trial ever undertaken using a drug or nutrient, said Dr. Scott Lippman, chairman of clinical cancer prevention at M.D. Anderson Cancer Center in Houston.

Dr. Lippman said a large 10-year placebo-controlled U.S. trial began in 1983 to test whether a daily dose of 200 micrograms of selenium could prevent skin cancer. Although the supplementation did not have significant effects on the incidence of skin cancers, the incidence of prostate cancer, colorectal and lung cancers was significantly reduced in subjects taking the supplement as compared to those receiving the placebo. The role of selenium in cancer prevention might be due to its incorporation into one of the body's most potent antioxidants, the enzyme glutathione peroxidase, as reported in several earlier studies.

A new study on elderly subjects shows that micronutrient levels influence the number and function of natural killer (NK) cells - immune cells that defend the body against some tumors. To explore the connection between micronutrients and NK cells, the researchers studied 62 northern Italian men and women who lived independently and who ranged in age from 90 to 106 years. All were in good health, had normal blood test values, and were not taking nutritional supplements or medications that affect the immune system, such as anti-inflammatory drugs or hormones. All were apparently well nourished.

However, the investigators found that many of these individuals had micronutrient deficiencies. The most common deficiency, found in about 50% of both men and women, was in selenium, an essential mineral and antioxidant that protects the heart. Fifty-two percent of the men and 41% of the women were deficient in zinc, which plays a role in wound healing, proper growth, and immune system functioning. Deficiencies were also noted in vitamins A, E, B6, and folate (a type of vitamin B complex), as well as in ubiquinone-10, which is associated with cell functioning.

It was found that higher serum levels of selenium in women corresponded to greater NK-cell activity. In women only, the defensive activity of the NK cells was greater when blood levels of vitamin E and ubiquinone-10 were higher. No other significant associations of micronutrients with NK cells were noted.

American Journal Clinical Nutrition 2000;71:590-598.

Researchers from the University of Miami found that selenium therapy (in the form of the yeast supplement Selenomax) has a strong potential for improving the mental state and well-being of HIV-1 seropositive drug abusers. The one-month pilot study of selenium supplementation in such subjects revealed that Selenomax administration was associated with a decreased risk in the development of depressed-dejected mood state1.

Over 95% of the selenium in selenium yeast supplements such as Selenomax is present in the form of L-(+)-Selenomethionine2.

  1. Health Supplement Retailer, February 2000, page 16.

  2. Proc. 6th Int. Symp. On Uses of Selenium and Tellurium. Uses of Selenium and Tellerium. (1998) Y. Palmieri, ed. Scottsdale, AZ, May 10-12, pages 77-79

L-(+)-Selenomethionine from Sabinsa Corporation is a selenium supplement with superior bioavailability. Selenium in selenium yeast occurs in the form of L-(+)-Selenomethionine.

 
   
  Validated HPLC Method for the Assay of L-(+)-Selenomethionine  
 
 

An HPLC method has been developed and validated for the analysis of L-(+)-Selenomethionine on a Thermoquest PDA System using a Phenomenex Aqua Column and standardized chromatographic conditions. The method provides accurate values of L-(+)- Selenomethionine content and measures the levels of free methionine in commercial samples of L-(+)-Selenomethionine. We take this opportunity to congratulate Mr. Robert DiGiovanni, Senior Analytical Chemist at Sabinsa R & D, Princeton NJ and Dr. K. Alagesan, Group Leader, Analytical Method Development at SAMI Labs Ltd., Bangalore, India - the scientists who effected the successful completion of this project.

 
   
  Boswellin® - a safe topical anti-inflammatory agent  
 
  A new study confirms that an ointment preparation containing 5% Boswellin® is free from dermal toxicity. In this study, 15 healthy volunteers in the 23-41 year age group were subjected to patch tests on five healthy forearm skin areas each. Finn chambers, a patch test device that provides good occlusion because of the chamber design, were used. The ointment was applied onto a vaseline album and also introduced into empty Finn chambers.

No skin reaction in terms of erythema, papule, blisters, dryness, itching, burning or odor was reported by any of the volunteers after 24 and 48 hours. Objective evaluation by the examining doctors also revealed no untoward reactions, with identical results being recorded for the vaseline album and testing in an empty Finn chamber. The preparation containing Boswellin® was thus well-tolerated by all the volunteers. It was therefore concluded that Boswellin® is a safe topical agent that does not sensitize the skin or manifest dermal toxicity.
 
   
  New research on Lutein Lutein reduces risk of colon cancer  
 
  The objective of this study was to evaluate associations between dietary ß-carotene, lycopene, lutein, zeaxanthin, and ß-cryptoxanthin and the risk of colon cancer. Data were collected from 1,993 case subjects with first primary incident adenocarcinoma of the colon and from 2,410 population-based control subjects. The subjects participating in the study were asked about their food intake in the previous 2 years (cancer-free participants) or the 2 years prior to their diagnosis (cancer patients).

The researchers found that those who had the highest intake of lutein-rich food had a 17% lower risk of colon cancer than those who ate the least amount. Lutein-rich foods include dark leafy vegetables, such as spinach, broccoli and lettuce, as well as tomatoes, oranges, orange juice, carrots, celery, greens and eggs. The lutein-associated risk reduction occurred in both men and women and was stronger among subjects whose cancer was diagnosed before the age of 67 and among subjects whose tumor was located farther up in the colon.

The authors did not find any correlation between colon cancer risk and other dietary carotenoids such as beta-carotene, which is found in carrots and green leafy vegetables, and lycopene, which is found in tomatoes. Research has shown that these compounds may contribute to a lower risk of different types of cancer.

American Journal of Clinical Nutrition 2000;71:575-582.

 
   
  Lutein reduces risk of cataracts  
 
  Dietary antioxidants, including carotenoids, are hypothesized to decrease the risk of age-related cataracts by preventing oxidation of proteins or lipids within the lens. New studies by Harvard University researchers show that lutein and zeaxanthin, carotenoid antioxidants found in dark green, leafy vegetables and many dietary supplements, may help reduce the risk of cataracts, a disease that affects more than half the people over age 65. These studies show that women with the highest intake of lutein and zeaxanthin had a 22 percent reduced risk for cataracts; men had 19 percent reduced risk.

A report from the Lutein Information Bureau advocates that people who do not consume enough lutein in food should consider a dietary supplement providing at least 6 mg per day.

American Journal of Clinical Nutrition 1999 Oct;70(4):509-24

Sabinsa Corporation supplies Lutein soft extract standardized to contain a minimum of 5% lutein esters.

 
   
  Marketing Focus: Asha Ramesh  
 
 
Asha Ramesh recently joined Sabinsa’s New Jersey office where she is responsible for coordinating with Sabinsa’s customers. Asha Ramesh holds a Masters Degree in Business Administration with a specialization in Marketing Management from Bangalore University in India and a Bachelors Degree in physics, chemistry, and mathematics from the same university. For the past five years, Asha was Manager of Purchases & Special Projects at Sabinsa’s manufacturing facility, SAMI Labs Ltd. We take this time to welcome Asha aboard!
 
   
  Bioavailability catches attention of the NIH  
 
  Sabinsa has recently participated in a conference on Bioavailability of Dietary Supplements organized by The Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH), Bethesda, Maryland. The conference was chaired by Mary Frances Picciano, Ph.D., Professor Nutritional Science, Penn State University, currently serving as Visiting Nutrition Scientist, ODS/NIH.

This important event by the NIH group reflects the changing pattern of use of nutritional supplements, with consumers clearly taking charge of their health. This new reality necessitates a debate on efficacy, safety and bioavailability of nutritional supplements. The objective of the conference was to explore the current state of our knowledge about the important issues related to the bioavailability of nutrients and other bioactive components of dietary supplements.

The conference was divided into four plenary sessions. Session 1 covered implications of bioavailability related issues to implementation of DSHEA, e.g. content on the label vs. content of the finished product, bioavailability and structure function claims, the importance of bioavailability data to the establishment of dietary reference intakes or DRIs. Session 2 addressed general issues related to the bioavailability of the supplements, e.g. measurements of bioavailability and key factors impacting the endpoints for measuring bioavailability. Session 3 discussed impact of bioavailability on physiologic state, e.g. bioavailability of selected nutrients in children, adults and elderly. Session 4 focused on three major classes of dietary supplements, i.e. vitamins, minerals and botanicals, and the bioavailability of selected nutrients representative of these major classes were presented, i.e. folate and iron.

The speakers’ sessions were followed by five workshop sessions with the goal to discuss the following topics: what do we need to know about active ingredients?, what is the impact of formulation on bioavailability?, physiological determinants of bioavailability, methodologies, and what are the best ways to communicate the information to the consumers?

One of the key questions that that the conference tried to answer was: what is the definition of the bioavailability? The consensus among the participants of the conference was that bioavilability is crucial to the health benefits of a supplement; however, no Federal regulations require any specific level of bioavailabilty. The term bioavailability, often confused with the gastrointestinal absorption, should actually include both the efficiency of absorption as well as utilization of a nutrient. Therefore, besides the blood levels of a supplemented ingredient the functional outcome should also be measured, e.g. blood levels of calcium and its impact on bone density of postmenopausal women.

Another important discussion concerned the factors affecting the bioavailability of nutrients. Although macronutrient bioavailability (fat, protein) is not affected in human aging, the bioavailability of several micronutrients is diminished in elderly people, e.g. B12, folate, iron, calcium and fat soluble beta-carotene.

During the worksop session on Impact of Formulation on Bioavailability, Sabinsa had brought the importance of supplements like the multi-patented Bioperine® (black pepper extract standardized for alkaloid piperine) to the attention of the workshop panel and the audience. Bioperine® has bioenhancing activity proven in clinical studies with fat soluble and water soluble vitamins, as well as organic forms of minerals (e.g. complex of selenium with amino acid methionine).

Overall the conference was a good forum for the exchange of ideas and experiences regarding the bioavailability of nutrients and the development of an effective research agenda which would be a source of reliable information to health professionals’ end consumers.

 
     
 
"The information presented in the "Current Issues" Newsletter from Sabinsa Corporation is for informational purposes only. It is abstracted from web and print media sources. Readers are advised to refer to the original sources for additional information".
 
   
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