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Current
Issues - Newsletter
February - March 2000 |
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FDA
revises position on dietary supplements during pregnancy |
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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.
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More Secrets of Selenium Revealed
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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.
- Health Supplement Retailer, February 2000, page
16.
- 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.
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Validated
HPLC Method for the Assay of L-(+)-Selenomethionine |
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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.
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Boswellin®
- a safe topical anti-inflammatory agent |
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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.
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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. |
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New research
on Lutein Lutein reduces risk of colon cancer |
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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).
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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.
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Lutein
reduces risk of cataracts |
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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. |
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Marketing
Focus: Asha Ramesh |
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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! |
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Bioavailability
catches attention of the NIH |
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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.
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| "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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