Formulating an Isoflavone Product

What are isoflavones? Where do they come from? And why develop dietary supplements with isoflavones?

What are isoflavones? They are polyphenolic compounds found in foods such as legumes (soy, chickpeas, beans and lentils) and in red clover. The five major isoflavones are genistein, daidzein, glycitein, formonetin and biochanin.

Why formulate products with isoflavones? Numerous in vitro, animal and human studies have shown the beneficial effects that some food products containing isoflavones can have on health. These benefits include lowering cholesterol, improving hormonal balance, supporting bone density and supporting different body systems. Many companies today sell soy or red clover isoflavone products to add to capsules or tablets. Soy protein isolate standardized to isoflavones was one of the first dietary supplement powders to deliver isoflavones with supporting research studies showing health benefits. It has been shown to help reduce the severity of menopausal symptoms, support hormonal balance, lower cholesterol and may improve bone density.

Consumers who do not like the taste of soy prefer to get their health benefits delivered in a capsule. Research on isoflavones delivered in capsules has been performed, but product claims are limited based on the strength of the published studies. Recently a meta-analysis was published in the Journal of the American Medical Association (JAMA) evaluating 11 soy isoflavone trials and six studies involving red clover isoflavones. The results favored the soy isoflavone products over the red clover, although the overall results were not significantly favorable for either. However, many companies are presently working hard, developing well-designed research studies on their isoflavone products. Significant results are necessary to talk about claims or benefits in marketing copy. In the past, many companies tried to make claims on soy isoflavone products in capsule form based on research on soy protein isolate with isoflavones. The comparison is not apples to apples. The research used soy protein from foods or soy protein isolate in powder form. The soy health claims approved in the United States and United Kingdom are based on soy protein and don’t cover extracted isoflavones or other soy components. More companies that manufacture soy isoflavones for inclusion in capsules or tablets are doing their homework, and their research groups continue to study these compounds to show the benefits of the extracted component.

Obviously, one of the main duties for product developers is to find ingredients that have substantial research to support a function of an ingredient. Fortunately, isoflavones have support in a number of areas.

• Isoflavones for hormone balance: Research suggests the consumption of soy containing isoflavones provides a beneficial effect on hormones in pre-menopausal and postmenopausal women, although it is wise for product developers to investigate the research to determine proper dosage and categories of women to target. Products containing soy, such as texturized vegetable protein (TVP) and tofu (soybean curd), contain high levels of the isoflavones genistein and daidzein. Besides influencing estrogen, soy isoflavones from TVP, soymilk or soy protein isolate have demonstrated effects on other hormones and the menstrual cycle. Most natural sources of isoflavones are considered to have a weak estrogenic effect and have the ability to attach to estrogen receptor sites. One study was performed with young women administered soy isoflavones in the form of soy protein, TVP or soymilk. Soy isoflavones reduced mid-cycle luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels. It also increased the length of the menstrual cycle and reduced urinary estrogens along with harmful genotoxic estrogen metabolites. Some researchers believe that isoflavones may be harmful to younger women and this has brought some controversy in the medical community. In developing products for the general public one should keep in mind the wide population that may take the products.
• Isoflavones to support women during menopause: Isoflavones have been shown as beneficial to women during menopause, when their estrogen levels are reduced. Isoflavones attach to the estrogen receptor sites and help promote normal levels of estrogen in the body. If women have elevated estrogen, it is believed isoflavones prevent estrogen from attaching, resulting in a weaker estrogenic effect. Many soy product claims are based on population studies showing soy with isoflavones has been used for centuries by Asian women with more balanced hormone levels. The soy products used in many of the studies for postmenopausal women delivered 34 to 165 mg/d of isoflavones. Red clover is another source of isoflavones available for use in a menopausal product. It contains the isoflavones formonetin and biochanin. The red clover product Promensil has reduced menopausal symptoms of hot flashes by 44 percent, compared to the placebo, with a dose of 80 mg/d of isoflavones. Another study published in JAMA showed some biological effect on menopausal symptoms, but it stated the effects were not clinically important.
• Isoflavones to support bone health: Soy protein isolate contains calcium beneficial to bone. The Osteoporosis Prevention Using Soy (OPUS) project is presently underway and aims to determine whether soy isoflavones are beneficial for bone health and safe over a two-year period. Ipriflavone is another popular isoflavone, which is synthesized from daidzein and has multiple research studies in humans and animals demonstrating its ability to inhibit bone resorption, promote the formation of bone and improve bone density. Still, other research shows it does not have estrogenic properties. There have been over 60 human clinicals demonstrating its effects on preventing bone loss.
• Product developers should review all the research to understand its use and mechanism of action. Also in product formulation, it is wise to combine isoflavones with some form of calcium, since the majority of research combines the two for a beneficial effect on bone health.
• Isoflavones to support prostate health: Another consideration for the use of isoflavones is in a prostate support product. There is epidemiologic and research that favors the use of isoflavones for prostate health. This research demonstrates isoflavones may help reduce benign prostatic hypertrophy (BPH). Higher plasma isoflavone levels and reduced prostate disease risk has been observed in Japanese and Chinese men more than in men from Britain, Finland and Portugal.
• Antioxidant benefits: There is research that demonstrates genistein and daidzein inhibit the production of free radicals including hydrogen peroxide and superoxide.

There are great market opportunities in the dietary supplement industry for using components of soybeans for health benefits. There are soy concentrates and isolates that provide standardized isoflavone levels. One of the issues in working with soy protein is the flavor, although there are presently various masking flavors that can be added to produce a good tasting product. In powder formulations, technology continues to improve the ability to deliver good tasting products with extensive functional properties. Viscosity, mouthfeel, stability and good solubility are other important factors to consider. There are also beverages, soy nuggets, bars and other snacks that utilize soy protein isolates high in protein, isoflavones and other components that appeal to the consumers looking for longterm health benefits. Formulating a soy product that contains other ingredients also has to be a careful process, since the other ingredients may affect the texture or taste. For example, fiber is an important nutrient that is deficient in many diets; but, adding it to a soy product in large amounts can flatten the taste.

In addition, it is recommended that products containing soy provide a warning that individuals taking drugs such as warfarin check with their physician prior to use, since soybeans contain vitamin K, which may interfere with the anti-blood clotting effects of those pharmaceuticals.

Isoflavones have great market potential. The scientific developments involving soy should be watched closely, since new research is continually on the horizon and bound to provide new product opportunities.

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