Isoflavones are related to health benefits such as relief of menopausal symptoms, PMS, bone health, and heart health. Soy isoflavones are characterized by a molecular structure quite similar to that of estrogens, but without being mammalian hormones with all their undesired side-effects. They are therefore believed to play an important role in supporting health during menopause by restoring the natural balance in the body.
In July 2009, the European Patent Office (EPO) decided to uphold the validity of an application patent (EP 0656786) for the use of isoflavones in medicaments treating menopausal symptoms. This patent is part of a series of Intellectual Properties related to isoflavones that covers the use of isoflavones for major health indications. Health ingredients manufacturer Frutarom is the sole sub-licensee for this patent for soy germ sourced isoflavones with its SoyLife products.
Composition
SoyLife is a natural ingredient from soy germ, containing 2%, 10% or 40% isoflavones. SoyLife 40% is a soy germ extract standardized to 40% isoflavones (Table 1).
The SoyLife product range is produced from specially selected soy germs. Due to gentle processing, SoyLife contains, besides isoflavones, a rich variety of compounds such as vitamin E, saponins, folic acid, and many others, and thus represents the soy germ in its natural composition. This complete spectrum of soy compounds is called the soy matrix and enhances the bioavailability of the isoflavones. The SoyLife product range can therefore be seen as a multi-component ingredient, more than a simple isoflavone extract, produced from hexane-extracted soy molasses.
Numerous studies, especially epidemiological studies in Asian populations that have a traditionally high intake of soy foods, show that isoflavones in their natural composition of soy micronutrients show health benefits. A clinical trial showed that isoflavones from the soy germ were more bioavailable than from a high-genistein soy-molasses extract (Zheng Y et al (2004) The Apparent Absorptions of Isoflavone Glucosides and Aglucons Are Similar in Women and Are Increased by Rapid Gut Transit Time and Low Fecal Isoflavone Degradation J Nutr 134 2534–2539).
Isoflavone Profile is Important
The isoflavone profile of SoyLife 40% has a typical soy germ ratio of genistein:daidzein:glycitein, reported in Table 2. Of interest is the high content of daidzein, the precursor of equol, an especially potent isoflavone. Equol has become increasingly important in understanding the efficacy of soy and isoflavone products, ranging from bone health to menopausal symptoms and also anti-cancer properties.
The new, emerging science about equol was the highlight of a half-day session at the Soy Health Symposium in Tokyo in November, 2008.
Clinical studies
Clinical trials have demonstrated the effect of SoyLife for two major women’s health indications: a) menopausal symptoms (ie hot flashes) and b) osteoporosis. All isoflavone treatments below are presented as aglycone equivalents.
a) Menopausal symptoms
- A double-blind, placebo-controlled study performed at Sao Paulo State University with 50 women showed that 60mg/day of isoflavones from SoyLife was effective to reduce menopausal symptoms (hot flushes) in women contra-indicated for hormone replacement therapy (Nahas EP et al (2003) Benefits of soy germ isoflavones in postmenopausal women with contraindication for hormone replacement therapy. Maturitas 48 372-380).
- In a single-blind study, done in 2003 at the Sun Yatsen University, Guangzhou, China, 87 earlymenopausal women were randomly assigned to a daily treatment of 84 mg or 126 mg isoflavones or a placebo. As a positive control, 10 women were treated daily with 2.5 mg estrogen. The estrogen group suffered from more severe menopausal complaints and were seeking help at the hospital. During the 24- week study period, subjects recorded their hot flash frequency every fourth week. In addition, the Kuppermann index was used to score the severity of a more complete set of menopausal complaints.An isoflavone intake of 84 mg/day from SoyLife was shown to reduce hot flash frequency and menopausal symptom score (p<0.01) (Figure 1). Larger doses did not have any additional benefits in reducing menopausal symptoms. The remaining menopausal symptoms after treatment with HRT were not significantly different than for SoyLife. (Ye Y et al (2007) A prospective clinical trial of soygerm isoflavone extract reducing menopausal symptoms in menopausal women; presented at the 7th Internat Soy Sym, Bangkok)
b) Osteoporosis
Early studies with SoyLife in postmenopausal Chinese women showed a significant dose-dependent effect on bone health.
A double-blind placebo controlled study of 203 subjects, receiving either placebo, 40 mg or 80 mg isoflavones from SoyLife plus 500 mg calcium and 125 IU vitamin D for one year showed that women receiving the higher dose had significantly higher favorable change rate in bone mineral content (BMC) at the total hip and trochanter (Figure 2). Women with the lowest initial BMC experienced the best results (Chen Y et al (2003) Soy isoflavones have a favorable lower bone mass: a double-blind, randomized, controlled trial J Clin Endocrinol Metab 88 4740-4747). The effects of soy on the maintenance of hip BMC was more marked in women in later menopause (>4 years) or in women with a lower body weight or calcium intake (Chen Y et al (2004) Beneficial effects of soy isoflavones on bone mineral content: a double-blind, randomized, controlled trial Menopause 11 246-254).- A single-blind randomized, placebo-controlled trial of 90 postmenopausal women (all taking 300 mg Ca + 100IU Vit D); treated for 6 months with 84 or 126 mg isoflavone or placebo, found positive effect on BMD, with most significant effects seen in women with lowest BMD (Ye et al (2006) Soy isoflavones attenuate bone loss in early postmenopausal Chinese women Eur J Clin Nutr 45 327-334) (Figure 3).
- The OPUS (Osteoporosis Prevention Using Soy) Study. The primary goal of the OPUS study was to determine whether isoflavones are effective and safe in preventing osteoporosis. A total of 404 postmenopausal women were enrolled in this multi-center, 2-year follow-up, randomized, double-blind, placebo-controlled clinical trial. One-third of the women received a placebo; one-third received isoflavone-therapy at 80/day; and the remaining one-third received isoflavone-therapy at 120 mg/day. Furthermore, all participants were supplemented daily with 1000 mg of calcium carbonate and a multivitamin providing a dose of 400 IU/day of vitamin D.Preliminary results were presented by William W. Wong of Baylor College of Medicine, TX-USA at the 7th International Soy Symposium in Bangkok (Thailand), March 6–9, 2007. Favorable effects were observed on whole body bone mineral density at the dose of 120 mg/die. The OPUS study also demonstrated the high bioavailability of the isoflavones after oral intake of SoyLife in the form of tablets, as indicated by its blood levels in the subjects participating to the study. The OPUS efficacy study has been accepted and is pending publication in a peer-reviewed journal.
Safety
Frutarom has performed standard toxicity testing showing no adverse effects even at high doses;, conclusions confirmed for the human situation in the OPUS study, showing that soy isoflavone therapy over a period of two years at a dosage as high as 120 mg isoflavones/day can be considered as safe. This conclusion was based on the clinical blood chemistries, physical examinations and the absence of reports of treatment-related side effects. A study on breast-health based upon the OPUS data, published in 2009, indicates that soy-germ isoflavones do not impact breast density (Maskarinec G et al (2009) Various doses of soy isoflavones do not modify mammographic density in postmenopausal women J Nutr 139 981-986).
Application and dosage
A dosage of 100 mg of SoyLife 40% provides 40 mg isoflavones in glycoside form.
The ingredient offers the convenience for one-per-day isoflavone capsules or tablets. The ingredient is also ideal for soft-gel capsules as it has a light color and relatively fine particle size. The chemical-physical properties of SoyLife 40% are reported in Table 3.
For information Veronique Renkert, akp public relations tel +49 6201 1889810 email renkert@akp-pr.de web www.akp-pr.de
Frutarom in a nutshell
Established in 1933, Frutarom is a rapidly growing global flavor and fine ingredients company and is numbered among the ten leading companies in the world, in the field of flavors & fragrances. Frutarom creates, develops, manufactures and markets an extensive variety of high quality flavors and fine ingredients for customers in the food, beverage, functional food, flavor, fragrance, pharmaceutical, nutraceutical, and cosmetic industries. The company markets and sells over 20,000 products to more than 10,000 customers in 120 countries, has 25 R&D labs and 45 sales and marketing offices throughout the world and operates 19 production facilities in Europe, North America, Israel and Asia.
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