The science

More than 35 proprietary scientific studies have confirmed the safety and efficacy of SoyLife® in alleviating menopausal symptoms and supporting bone and cardiovascular health, making it one of the most researched isoflavone ingredients. SoyLife® has also shown to be effective for gut health and skin care.

The efficacy and safety profile of SoyLife® have been extensively investigated in multiple scientific studies, ranging from in-vitro experiments to clinical trials. SoyLife® is protected by a large portfolio of intellectual property, including several patents. Frutarom continues to fund research to further support the clinical efficacy and safety of SoyLife®.

Please contact us for study summaries and more information on the science behind SoyLife®.

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Bone Health

Estrogen plays an important role in bone metabolism, especially the mechanisms related to calcium resorption. For post-menopausal women, bone mineral density and mass is more rapidly reduced as their bodies naturally produce less estrogen. SoyLife® isoflavones can help build bone strength and prevent bone loss leading to osteoporosis.

Osteoporosis Prevention Using Soy (OPUS) is a study supported by US government and designed to investigate safety and efficacy of soy isoflavones as natural alternative for prevention of osteoporosis in postmenopausal women.

On average, postmenopausal women lose 4% bone mass per year. This bone loss leads to osteopenia and osteoporosis, and greatly raises the risk for bone fractures in post menopausal women. Hormone replacement therapy (HRT) used to be a treatment of choice, but increasingly alternative therapies are being sought, given the increased risk of certain cancers upon HRT use. The primary goal of the OPUS study was to determine whether isoflavones have an effect on reducing bone loss after menopause, whether they are safe during long-term use and what the optimal dosage is.

It is in the line of expectations that whole body bone mineral density BMD and BMD T-scores decline during the study period in all study groups, due to the natural physiology in postmenopausal women. It was noted, however, that in the group taking 120mg/d of isoflavones, the reduction in WB BMD was significantly reduced at both year 1 and year 2 compared to placebo. Although these women kept experiencing loss of bone mass, the rate of loss was reduced.

The OPUS study was a unique study to examine possible effects of isoflavones: a 2-year duration, a large sample size, uniform measurements, and 2 different dosages of isoflavones were tested. In this trial, isoflavone supplements positively influenced whole body BMD, at a dosage of 120mg/day. In addition to the BMD results, the study also showed that long-term intake of soy germ isoflavones in high concentrations do not have a negative influence on breast health.

In postmenopausal women, natural loss of Bone Mineral Density (BMD), measured in g/cm2, is generally indicated an average of 4% per year, especially during the first 5 years after the start of the menopause. This study showed that at all three bone sites (femur’s neck, Ward’s Triangle and lumbar spine), SoyLife® isoflavones not only prevented loss of BMD, but even increased BMD. A clear dose-response curve was established for BMD-increase in all sites between 84 and 120 mg of isoflavones per day.

* Wong et al 2009 Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial, Am. J. Clin. Nutr. 90(5) (2009), 1433-1439.

* Weaver et al 2009 Antiresorptive effects of phytoestrogen supplements compared with estradiol or risendronate in postmenopausal women using Ca methodology. J. Clin. Endocrin. and Metabolism 94(10) (2009), 3798-3805.

* Chen et a 2003 Beneficial effect of soy isoflavones on bone mineral content was modified by years since menopause, body weight, and calcium intake: a double-blind, randomized, controlled trial, Menopause 11 (2004), 246-254.

* Chen et al 2003 Soy Isoflavones have a favorable effect on bone loss in Chinese postmenopausal women with lower bone mass: a double-blind, randomized, controlled trial, J. of Clin. Endocrin. & Metabolism 88 (2003), 4740-4747.

* Ye et al 2003 A prospective clinical trial of soybean isoflavones extract attenuating bone loss in postmenopausal women, Eur. J. Nutr. 45 (2006), 327-334.

* Zou et al 2001 Effects of soybean isoflavones on rat osteoblast cells in vitro, unublished results.

* Cavalié et al 2002 Effects of endurance running and/or isoflavones on bone mineral density in ovariectomized adult female rat, Science et sports 17 (2002), 312-314.

* Wong et al 2001 Effects of soy isoflavones on biochemical markers of bone metabolism in postmenopausal women, Presented at “Dietary Phytoestrogens: Friend or Foe, New Orleans, USA. 2001.

Heart Health

Women entering menopause are at an increased risk of developing high cholesterol/triglyceride levels, as well as high blood pressure. Isoflavones help prevent or inhibit the increase in LDL (bad) cholesterol – which leads to an improvement in the LDL/HDL ratio.

When estrogen production drops during menopause, it results in a higher risk of hypercholesterolemia and hypertension in postmenopausal women. Hormone replacement therapy (HRT) can have beneficial effects for these women. It lowers blood lipid concentration and increases arterial compliance in postmenopausal women. However its long-term safety is under discussion. Isoflavones may be a natural alternative for HRT. Isoflavones, found in abundance in soybeans, are compounds with a weak estrogenic effect. In this study they were evaluated for their effects on blood lipid parameters and blood pressure in postmenopausal women.

After the isoflavone treatment, no significant change was observed in body weight or in blood concentrations of total cholesterol (TC). However, a reduction in low-density lipoprotein cholesterol (LDL-C, the “bad” cholesterol) was found. Blood concentrations of high-density lipoprotein cholesterol (HDL-C, the “good” cholesterol) were elevated by 5%.

No significant change in systolic blood pressure was measured. However, there was a significant reduction in diastolic blood pressure of 12%.

* Curtis et al 2012 Chronic Ingestion of Flavan-3-ols and Isoflavones improves Insulin Sensitivity and Lipoprotein Status and Attenuates Estimated 10-year CVD Risk in Medicated Postmenopausal Women With Type 2 Diabetes, Diabetes Care 35:226-232, 2012.

* Hsu et al 2007 The effects of soygerm extracts on blood lipoproteins, antioxidative capacity and urinary estrogen metabolites in postmenopausal women on hormone therapy, Int. J. of Gynecology and Obstetrics 98(1) (2007), 29-33.

* lerici et al 2007 Pasta naturally enriched with isoflavone aglycons from soy germ reduces serum lipids and improves markers of cardiovascular risk, J. Nutr. 137 (2007), 2270-2278.

* Garrido et al 2006 Soy isoflavones effect platelet thromboxane A2 receptor density but not plasma lipids in menopausal women, Maturitas 53(3) (2006), 270-6.

* Wong et al 2001 Effects of soy isoflavones on blood lipids and blood pressure in postmenopausal women, Pres. at “Dietary Phytoestrogens: Friend or Foe”, New Orleans, 2001.

* Song et al 2003 Soy protein with or without isoflavones, soy germ and soy germ extract, and daidzein lessen plasma cholesterol levels in golden Syrian hamsters, Exp. Biol. Med. 228 (2003), 1063-1068.

Skin Care

Skin aging is influenced by internal and external factors, such as changes in estrogen production and exposure to free radicals. During and after menopause, falling estrogen levels cause a decrease in general skin tone, wrinkles and sagging. Aging skin tissue typically stiffens and loses elasticity. The responsible process for this is called collagen protein glycation and occurs because glucose forms cross-links between collagen molecules, making collagen protein less flexible.

It has been shown that SoyLife® isoflavones have a possible anti-aging effect on skin tissue by reducing the glycation of collagen protein. As a result, it helps maintain the skin’s elasticity, both applied topically and taken orally. An in vitro study measuring Advance Glycosylation Endproducts (AGE) showed that SoyLife® EXTRA (standardized on 10% isoflavones) may have an anti-aging effect on skin tissue by reducing the glycation of collagen protein. As a result, the process of elasticity loss in the skin may be slowed down.

SoyLife® was incorporated in a standard cream (with a final concentration of 0.18% isoflavones) and tested on healthy menopausal women. The study was performed on two groups of each 10 healthy menopausal women (45-65 yrs). One group used the SoyLife cream and the second a placebo cream. The subjects used the cream twice a day for 8 weeks. On day 0, day 28 and day 56 silicone prints of the crow’s feet were taken from each subject. The anti-wrinkle effect was measured using Skin Analyzer.

After day 28 the SoyLife® cream significantly reduced the number of deep wrinkles by 24%. This effect was maintained at 22% after 56 days. The placebo group did not show a significant effect.
Cutaneous microcirculation (skin blood flow) was tested in 10 healthy menopausal women who used the standard cream with SoyLife®EXTRA, twice a day for eight weeks. On day 0 and on day 56 cutaneous microcirculation was measured by a Laser Doppler on the cheeks of the subject. Results show that after using the SoyLife® cream, the skin blood flow decreased significantly. After 8 weeks, a decrease of 36.5% was observed. SoyLife® EXTRA can therefore be used in creams to calm skin redness and sensitive skin as well as to improve skin radiance.
Sensory evaluation was done with a subjective questionnaire regarding tolerance, organoleptic parameters and product efficacy. After 56 days of twice daily application the results show that SoyLife® cream was well accepted. Particularly good tolerance, high efficacy and very pleasant sensations were reported

* Dermscan 2000Protective effects of SoyLife® against protein glycation, unpublished results.

* Dermscan 2000 Evaluation, in vivo, on human subjects, of the anti-aging effect of SoyLife® EXTRA versus placebo.

Women’s Health & Menopause

As women go into menopause, their bodies naturally produce less estrogen. This lack of estrogen can lead to a number of symptoms including hot-flashes, insomnia and mood swings. Breast health and bone health are also affected by the reduced estrogen levels during menopause. Premenopausal woman who have undergone a bilateral oophorectomy (surgically induced menopause) often experience an abrupt menopause with more severe menopausal symptoms than those who have undergone menopause naturally.

Hormone replacement therapy (HRT) is recommended for the relief of vasomotor symptoms, treatment of vaginal atrophy and prevention of osteoporosis. While HRT may be beneficial against symptoms of menopause, its long-term safety is still being evaluated. In spite of the well-known advantages of HRT, approximately 70% of women drop out after the 1st year of treatment, due to irregular bleeding, breast pain, nausea, migraines, weight gain and water retention, and the fear of breast cancer. These side effects lead some women to opt for natural forms of treatment. SoyLife® isoflavones are derived from a natural source of non-GMO soy and can help alleviate menopausal symptoms and improve the quality of life.

* Nahas et al 2004 Benefits of soy germ isoflavones in postmenopausal women with contraindication for conventional hormone replacement therapy, Maturitas 48 (2004), 372-380.

* Secreto et al 2004 Soy isoflavones and melatonin for the relief of climecteric symptoms: a multicenter, double-blind, randomized study, Maturitas 47 (2004), 11-20.

* Ye Yan-bin et al Soy germ isoflavones improve menopausal symptoms but have no effect on blood lipids in early postmenopausal Chinese women: a randomized placebo-controlled trial, Menopause Vol.19, No. 7, (2012).

Memory and Cognitive Function

Isoflavones are natural phytoestrogens that are structurally similar to estrogen. Evidence from studies using SoyLife® show that men who supplement their diets with isoflavones may significantly improve their spatial working memory. Isoflavone supplementation in healthy males may enhance some cognitive processes which are dependent on estrogen activation. Many women also report “brain fog” and memory issues as the estrogen levels decrease with ageing.

SoyLife® products may have an overall positive effect on mental fitness in the elderly, significantly enhancing their quality of life.

Females perform better in certain memory-related tasks than males. Sex differences in cognitive performance may be attributable to differences in circulating estrogen acting on estrogen beta receptors (ERbeta). These receptors are numerous in brain regions that mediate cognitive functions such as the hippocampus, frontal lobe and cortex. Since soy isoflavones are known to activate ERbeta, chronic isoflavone supplementation in males may improve cognitive performance in memory-related tasks.

A 12-week double-blind, placebo-controlled cross-over trial was conducted in thirty-four healthy men to investigate the effect of isoflavone supplementation on cognitive function. Volunteers were randomized to take four capsules/day containing SoyLife® or placebo for 6 weeks, and the alternate treatment during the following 6 weeks. Assessments of memory (verbal episodic, auditory and working), executive function (planning, attention, mental flexibility) and visual spatial processing were performed at baseline and after each treatment period.

Isoflavone supplementation significantly improved spatial working memory (P = 0.01), a test in which females consistently perform better than males. Compared with placebo supplementation, there were 18 % fewer attempts (P = 0.01), 23 % fewer errors (P = 0.02) and 17 % less time (P = 0.03) required to correctly identify the requisite information. Isoflavones did not affect auditory and episodic memory (Paired Associate Learning, Rey’s Auditory Verbal Learning Task, Backward Digit Span and Letter-Number Sequencing), executive function (Trail Making and Initial Letter Fluency Task) or visual-spatial processing (Mental Rotation Task).

In conclusion, isoflavone supplementation in healthy males may enhance cognitive processes which appear dependent on estrogen activation.

* Thorpe et al 2009 Soya isoflavone supplementation enhances spatial working memory in men, B. J. Nutr. 102(9) (2009), 1348-54.

* Ho et al 2007 Effects of soy supplementation on cognitive function in Chinese postmenopausal women: A double-blind, randomized, placebo-controlled trial, Menopause. 14(3) (2007), 1-11.

Gut Health

Other soy constituents including dietary fiber, oligosaccharides, proteins, trace minerals and vitamins can influence wellbeing and impact the efficacy of isoflavones. Studies indicate the ability of soy germ powder to positively influence the composition of the gut microflora. This suggests that SoyLife® has a prebiotic activity.

Much of the research on health-promoting activities of soy products has been conducted focusing on the role of isoflavones. However, other soy constituents including dietary fiber, oligosaccharides, proteins, trace minerals and vitamins can also influence well-being and influence the efficacy of isoflavones. As a culture system for gut microflora, a Simulator of the Human Intestinal Microbial Ecosystem (SHIME) was used to evaluate the capacity of SoyLife® COMPLEX (standardized on 2% isoflavones) to modulate colonic fermentation. In addition, it was studied to what extent the microbiota metabolized the conjugated isoflavones present in the soy germ powder into aglycone isoflavones. The microbiota was subjected to a 2-week treatment by adding 2.5 gram per day of SoyLife® COMPLEX to the culture medium.

Addition of SoyLife® isoflavone-rich soy germ concentrate resulted in an overall increase of bacterial marker populations, with a significant increase of the Lactobacillus sp. population.

Gas analysis revealed a significant increase of methane concentration. The use of an electronic nose apparatus indicated that odor concentrations after passage through the intestinal tract decreased significantly during the treatment period.
A third observation from this study concerns the estrogenic activity of isoflavones. To enable this activity, glucosides are hydrolysed into aglycones by cleaving the β-glycosidic bonds. This study showed that a change in microflora increased the hydrolysis rate of the isoflavone glucoside, thus resulting in more aglycones. Using a yeast estrogen screen, the estrogenic activity was demonstrated in the crude SHIME-fermented extracts.

This was the first study showing the ability of soy germ powder to positively influence the composition of the gut microflora, suggesting a prebiotic activity. The estrogenic activity of SoyLife® was also confirmed.

* De Boever et al 2000 Fermentation by gut microbiota cultured in a simulator of the human intestinal microbial ecosystem is improved by supplementing a soy germ powder, J. Nutr. 130 (2000), 2599-2606.

* De Boever et al 2001 Combined use of Lactobacillus reuteri and soy germ powder as food supplement, Letters in Applied Microbiology 33 (2001), 420-424.