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TO HEALTH, MEDICAL, AND NATIONAL EDITORS:
Reproductive or Thyroid Hormones and Menstrual Cycle Not Influenced by
S-equol Supplement Designed to Manage Menopause Symptoms
NORTHRIDGE, Calif., April 4, 2014 /PRNewswire-USNewswire/ -- A daily
dose of S-equol (13.1 mg), delivered via a fermented soy germ-based
nutritional supplement to manage menopause symptoms, showed no impact
on reproductive or thyroid hormones or the menstrual cycles of
premenopausal women, according to a peer-reviewed study reported in a
poster at the Academy of Women's Health 2014 annual meeting in
Washington, DC.
Previous controlled clinical trials documented that daily doses of the
supplement containing S-equol, a metabolite of the soy isoflavone
daidzein, relieved menopausal symptoms, specifically hot flash
frequency and muscle discomfort, in both U.S. and Japanese
postmenopausal women.
"These data demonstrate that in premenopausal women, use of this
supplement does not impact levels of specific endocrine hormones.
Furthermore, the S-equol supplement does not impact menstrual cycles
of premenopausal women which helps to confirm and expand what we know
about safety of the S-equol supplement from previous studies," said
coauthor Belinda H. Jenks, Ph.D., Director of Scientific Affairs &
Nutrition Education at Pharmavite LLC, the makers of Nature Made@
vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co.,
Ltd., which supported the study.
S-equol has the ability to bind to the same estrogen receptors as
naturally occurring estrogen, with a strong affinity to the estrogen
receptor beta. On binding to the receptor, S-equol mimics some, but
not all, activities of estrogen. Because of these actions at the
receptor, it has been proposed that S-equol may alleviate some
menopause symptoms caused by diminished estrogen production.
No Impact from S-equol Supplements on Reproductive or Thyroid Hormone
Levels and Menstrual Cycle in Premenopausal Women During the treatment
period and post-treatment period, each of which was lasted for one
menstrual cycle in each subject, a dose of a supplement containing
13.1 milligrams (mg) S-equol daily did not significantly alter the
levels of five reproductive and three thyroid hormones from
pre-treatment values, which remained within the normal range and did
not differ from levels in women receiving a placebo in a study of 35
Japanese women aged 20 to 38 years. Moreover, neither the supplement
nor the placebo affected the length of the women's menstrual cycles,
which averaged 28.4 to 30.0 days, p=0.430 for the difference between
groups and p=0.921 for the differences in the three cycle phase
measures.
Specifically, the women receiving the supplement did not differ from
the 18 women receiving the placebo in delta changes of the levels of
luteinizing hormone (treatment minus pre-treatment: p=0.260 and
post-treatment minus pre-treatment: p=0.486), follicle stimulating
hormone (p=0.322 and p=0.456), estradiol (p=0.712 and p=0.703),
progesterone (p=0.085 and p=0.462) and testosterone (p=0.720 and
p=0.764). Additionally, the two groups did not differ in measures for
levels of thyroid stimulating hormone (p=0.082 and p=0.111), free T3
(a form of triiodothyronine) (p=0.197 and p=0.416) and free T4 (a form
of thyroxine), (p=0.223 and p=0.724).
Investigators took blood samples from each woman during the early
follicular phase, about three to five days after onset of the period,
the late follicular phase, about 10 to 13 days after onset of the
period, and the luteal phase, about seven to 10 days after ovulation.
The investigators repeated these blood samples during the course of
three sequential cycles. During the first and last cycles, the women
did not take any treatment, while during the middle cycle; the women
received either the supplement or a placebo based on random assignment
to a treatment group. This treatment lasted approximately four weeks,
depending on the duration of the women's individual cycles.
Only women who had regular menstrual cycles, 28 to 35 days, were
accepted and enrolled and of these, 12 were natural equol producers
after soy consumption. All of the women self-checked their ovulation
cycles using commercial urine tests.
The complete data will be submitted to a peer-review journal for
publication.
About Equol S-equol is a compound resulting from the natural
metabolism, or conversion, of daidzein, an isoflavone found in whole
soybeans.Not everyone can produce S-equol after soy consumption, as
the production depends on the types of bacteria present in the large
intestine. About 50 percent of Asians and 20 to 30 percent of North
Americans and Europeans, who in general consume less soy than Asians,
have the ability to produce equol.
The safety of the supplement containing S-equol previously was
confirmed by standard animal testing breast cancer model, including a
study documenting that S-equol itself, as well as the supplement
containing S-equol, did not increase or stimulate the growth of breast
cancer cells. Studies involving postmenopausal women who consumed the
supplement containing S-equol have not observed any safety problems,
including analysis of breast and reproductive tissues and of hormone
levels.
Development and ongoing research of a supplement containing S-equol is
conducted by the Saga Nutraceuticals Research Institute of Otsuka
Pharmaceutical Co., Ltd. Pharmavite LLC, a subsidiary of Otsuka, is
studying the supplement containing S-equol for the management of
menopausal symptoms.
More information about S-equol, including results of studies, is at
How the S-equol Supplement is Made The supplement is the product of
fermentation of whole soy germ by the bacterial strain Lactococcus
20-92 using a patented and proprietary process by the Otsuka
Pharmaceutical Co., Ltd. The process results in the conversion of the
soy isoflavone daidzein to S-equol. The S-equol ingredient is created
under current Good Manufacturing Practices. Following fermentation,
the bacteria undergo heat denaturation and are deactivated. The
process is designed to produce an S-equol rich product, or
nutraceutical ingredient. The ingredient has self-affirmed GRAS
(Generally Recognized As Safe) status.
Academy of Women's Health Poster , to be presented Saturday, April 5,
5:15-6:45 pm ET S-equol supplementation does not impact reproductive
or thyroid hormone levels and menstrual cycle in premenopausal women.
Soh Iwashita, PhD of Otsuka Pharmaceuticals Co., Ltd. and Pharmavite
LL; Belinda H. Jenks, Ph.D., Pharmavite LLC; Tomomi Ueno, MS, Atsuko
Onoda, M.S., and Shigeto Uchiyama, MS, all of Otsuka Pharmaceuticals
Co., Ltd.; and Takeshi Aso, M.D., Ph.D., Professor and Chairman
Emeritus, Department of Comprehensive Reproductive Medicine at the
Tokyo Medical and Dental University and President-Elect of the Asia
Pacific Menopause Federation.
About Pharmavite LLC: For more than 40 years, Pharmavite LLC has
earned and maintained the trust of healthcare professionals,
consumers, and retailers by manufacturing high-quality vitamins,
minerals and other dietary supplements, and all-natural foods under
its Nature Made@ and SOYJOY@ brand names. Based in Northridge,
California, Pharmavite LLC operates as a subsidiary of Otsuka
Pharmaceutical Co., Ltd. For more information, please visit
Pharmavite.com.
About Otsuka Pharmaceutical Co., Ltd.: Founded in 1964, Otsuka
Pharmaceutical Co., Ltd. is a global healthcare company with the
corporate philosophy: 'Otsuka-people creating new products for better
health worldwide.' Otsuka researches, develops, manufactures and
markets innovative and original products, with a focus on
pharmaceutical products for the treatment of diseases and consumer
products for the maintenance of everyday health. Otsuka is committed
to being a corporation that creates global value, adhering to the high
ethical standards required of a company involved in human health and
life, maintaining a dynamic corporate culture, and working in harmony
with local communities and the natural environment. Otsuka
Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka
Holdings Co., Ltd., the holding company for the Otsuka Group. The
Otsuka Group has business operations in 25 countries and regions
around the world, with consolidated sales of approximately USD 13
billion for fiscal year 2012 (4/1/2012-3/31/2013.) Visit Otsuka
Pharmaceutical Co., Ltd. at http://www.otsuka.co.jp/en/.
SOURCE Pharmavite LLC
-0- 04/04/2014
/CONTACT: Stephen McCauley, smccauley@porternovelli.com, 202-973-3615, Porter Novelli
/Web Site: http://www.pharmavite.com/
CO: Pharmavite LLC
ST: California
IN: HEA MTC PHA
SU: TRI WOM SVY
PRN
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0000 04/04/2014 13:00:00 EDT http://www.prnewswire.com
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