Soy (Glycine max [L.] Merr.)
  
Soy (Glycine max [L.] Merr.)
Background
Soy is a subtropical plant, native to southeastern Asia. This member of the pea family ( Fabaceae ) grows from one to five feet tall and forms clusters of three to five pods, each containing two to four beans per pod. Soy has been a dietary staple in Asian countries for at least 5,000 years, and during the Chou dynasty in China (1134-246 B.C.), fermentation techniques were discovered that allowed soy to be prepared in more easily digestible forms such as tempeh, miso, and tamari soy sauce. Tofu was invented in second century China.
Soy was introduced to Europe in the 1700s, and to the United States in the 1800s. Large-scale soybean cultivation began in the United States during World War II. Currently, Midwestern U.S. growers produce approximately half of the world's supply of soybeans.
Soy and components of soy called "isoflavones" have been studied scientifically for numerous health conditions. Isoflavones (such as genistein) are believed to have estrogen-like effects in the body, and as a result are sometimes called "phytoestrogens." In laboratory studies, it is not clear if isoflavones stimulate or block the effects of estrogen, or both (acting as "mixed receptor agonists/antagonists").
Synonyms
Coumestrol, daidzein, edamame, frijol de soya, genistein, greater bean, haba soya, hydrolyzed soy protein, isoflavone, isoflavonoid, legume, natto, phytoestrogen, plant estrogen, shoyu, soja, sojabohne, soybean, soy fiber, soy food, soy product, soy protein soya, soya protein, Ta-tou , texturized vegetable protein.
Selected brands used in human clinical trials : Abalon (Nutri Pharma ASA, Oslo, Norway); SOYSELECT (Indena SpA, Milan, Italy); Takeda (Italia Farmaceutici, SpA, Catania, Italy); Osteofix (Chiesi, Parma, Italy); Piascledine 300 (Pharmascience Laboratories, Courbevoie, France); Isomil DF (Ross Products Division, Abbott Laboratories, Columbus, Ohio); Prosobee (Mead Johnson, Evansville, IN, USA); Nursoy (Wyeth Laboratories); Nursoy Ready to Feed (Wyeth Laboratories); Isomil (Ross Laboratories, Columbus, Ohio); Hyprovit (Hayes Ltd., Ashdod, Israel); TakeCare (Protein Technology International, St. Louis, MO); Fibrim Brand Soy Fiber (Protein Technologies International, St. Louis, MO); Purina 660 (Ralston Purina Company, St. Louis, MO); Supro 660 (Protein Technologies International, St. Louis, MO); Supro 675 (Protein Technologies International, St. Louis, MO); Supro 675 IF (Protein Technologies International, St. Louis, MO); Supro Plus 675HG (Protein Technologies International, St. Louis, MO); Temptein (Miles Laboratories, Elkhart, Ind., USA).
Evidence
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Uses based on scientific evidenceGrade*High cholesterol
Numerous human studies report that adding soy protein to the diet can moderately decrease blood levels of total cholesterol and low-density lipoprotein ("bad" cholesterol). Small reductions in triglycerides may also occur, while high-density lipoprotein ("good" cholesterol) does not seem to be significantly altered. The greatest effects seem to occur in people with elevated cholesterol levels, with benefits lasting as long as the diet is continued. Total replacement of dietary animal proteins with soy protein yields the greatest benefits. People on low-cholesterol diets experience further reductions in cholesterol levels by adding soy to the diet. Some scientists have proposed that specific components of soybean, such as the isoflavones genistein and daidzein, may be responsible for the cholesterol-lowering properties of soy. However, this has not been clearly demonstrated in research, and remains controversial. It is not known if products containing isolated soy isoflavones have the same effects as regular dietary intake of soy protein. Dietary soy protein has not been proven to affect long-term cardiovascular outcomes such as heart attack or stroke.
A
Dietary source of protein
Soy products such as tofu are high in protein and are an acceptable source of dietary protein.
A
Menopausal hot flashes
Soy products containing isoflavones have been studied for the reduction of menopausal symptoms such as hot flashes. The scientific evidence is mixed in this area, with several human trials suggesting reduced number of hot flashes and other menopausal symptoms, but more recent research reporting no benefits. Overall, the scientific evidence does suggest benefits, although better quality studies are needed in this area in order to form a firm conclusion. Many researchers have attributed these effects to the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties), such as isoflavones. An area of concern has been whether phytoestrogens carry the same risks as prescription drug hormone replacement therapy (HRT), which contains estrogens, such as increased risk of hormone-sensitive cancers (breast, ovarian, uterine) or blood clots. This is an important area of concern for patients, as some women may consider soy as an alternative to HRT in order to avoid these risks. Early studies report that soy isoflavones do not cause the same thickening of the uterus lining (endometrium) as estrogen, and therefore may not carry the same risks as HRT. In addition, some scientists theorize that isoflavones may actually reduce the risk of cancer by blocking estrogen effects in the body, based on laboratory studies showing isoflavones to partially block (non-competitively inhibit) estrogen receptors. Additional research is needed in this area before a clear risk-assessment can be conducted.
B
Menstrual migraine
One study of a phytoestrogen combination in the prophylactic treatment of menstrual migraines reduced the number of migraine attacks suffered. Further research is needed before a recommendation can be made.
C
Diarrhea (acute) in infants and young children
Numerous studies report that infants and young children (ages 2 to 36 months) with diarrhea who are fed soy formula experience fewer bowel movements per day and fewer days of diarrhea. This research suggests soy to have benefits over other types of formula, including cow milk-based solutions. The addition of soy fiber to soy formula may increase the effectiveness. Although many of the trials in this area are not high quality, and some report conflicting results (lack of benefits), overall, the evidence supports this use of soy. Better quality research is needed before a strong recommendation can be made. Parents are advised to speak with a qualified healthcare provider if infants experience prolonged diarrhea, become dehydrated, develop signs of infection such as fever, or experience blood in the stool. A healthcare provider should be consulted for current breastfeeding recommendations, and to suggest long-term formulas with adequate nutritional value.
B
Diarrhea in adults
Due to limited human study, there is not enough evidence to recommend for or against the use of soy-polysaccharide/fiber in the treatment of diarrhea. Further research is needed before a recommendation can be made.
C
Breast cancer prevention
Several large population studies have asked women about their eating habits, and reported higher soy intake (such as dietary tofu) to be associated with a decreased risk of developing breast cancer. However, this type of research (retrospective, case-control, epidemiologic) can only be considered preliminary, because people who choose to eat soy may also partake in other lifestyle decisions that may lower the risk of cancer. These other habits, rather than soy, could theoretically be the cause of the benefits seen in these studies (for example, lower fat intake, more frequent exercise, lack of smoking). Controlled human trials are necessary before a firm conclusion can be drawn. Theoretical concerns have been raised that soy may actually increase the risk of breast cancer because of the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties), such as isoflavones. This remains an area of controversy. Recently, some scientists have theorized that isoflavones may reduce the risk of cancer by blocking estrogen effects in the body, based on laboratory studies showing isoflavones to partially block (non-competitively inhibit) estrogen receptors. In fact, early research suggests that soy isoflavones do not have the same effects on the body as estrogens, such as increasing the thickening of the uterus lining (endometrium). Genistein has been found in laboratory and animal studies to have other anti-cancer effects, such as blocking new blood vessel growth (anti-angiogenesis), acting as a tyrosine kinase inhibitor (a mechanism of many new cancer treatments), or causing cancer cell death (apoptosis). Until better research is available, it remains unclear if dietary soy or soy isoflavone supplements increase or decrease the risk of developing breast cancer.
C
Colon cancer prevention
There is not enough scientific evidence to determine if dietary intake of soy affects the risk of developing colon cancer.
C
Endometrial cancer prevention
There is not enough scientific evidence to determine if dietary intake of soy affects the risk of developing colon cancer. Theoretical concerns have been raised that soy may actually increase the risk of endometrial cancer because of the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties), such as isoflavones. This remains an area of controversy. Recently, some scientists have theorized that isoflavones may reduce the risk of cancer by blocking estrogen effects in the body, based on laboratory studies showing isoflavones to partially block (non-competitively inhibit) estrogen receptors. In fact, early research suggests that soy isoflavones do not have the same effects on the uterus as estrogens, such as increasing the thickening of the endometrium (lining of the uterus). Genistein has been found in laboratory and animal studies to have other anti-cancer effects, such as blocking new blood vessel growth (anti-angiogenesis), acting as a tyrosine kinase inhibitor (a mechanism of many new cancer treatments), or causing cancer cell death (apoptosis).
C
Prostate cancer prevention
It has been theorized that the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties) such as isoflavones may be beneficial in the treatment of prostate cancer. In addition, the isoflavone genistein has been found in laboratory and animal studies to have anti-cancer effects, such as blocking new blood vessel growth (anti-angiogenesis), acting as a tyrosine kinase inhibitor (a mechanism of many new cancer treatments), or causing cancer cell death (apoptosis). These mechanisms have not been clearly demonstrated to work in humans. Preliminary research has examined the effects of dietary soy intake on prostate cancer development in humans, but results have not been conclusive. Better study is needed before a recommendation can be made.
C
Cancer treatment
Genistein, an isoflavone found in soy, has been found in laboratory and animal studies to possess anti-cancer effects, such as blocking new blood vessel growth (anti-angiogenesis), acting as a tyrosine kinase inhibitor (a mechanism of many new cancer treatments), or causing cancer cell death (apoptosis). In contrast, genistein has also been reported to increase the growth of pancreas tumor cells in laboratory research. None of these effects has been adequately assessed in humans. In the past, theoretical concerns have been raised that soy may increase the risk of hormone-sensitive cancers (for example, breast, ovarian, endometrial/uterine) because of the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties), such as isoflavones like genistein. This remains an area of controversy. Recently, some scientists have suggested that isoflavones may actually reduce the risk of hormone-sensitive cancers by blocking estrogen effects in the body, based on laboratory studies showing isoflavones to partially block (non-competitively inhibit) estrogen receptors. Preliminary human research suggests that soy isoflavones do not have the same effects on the body as estrogens, such as increasing the thickening of the uterus lining (endometrium). Until reliable human research is available, it remains unclear if dietary soy or soy isoflavone supplements are beneficial, harmful, or neutral in people with various types of cancer.
C
Cardiovascular disease
Dietary soy protein has not been shown to affect long-term cardiovascular outcomes such as heart attack or stroke. Research does suggest cholesterol-lowering effects of dietary soy, which in theory may reduce cardiovascular risk. Soy has also been studied for blood pressure-lowering and blood sugar-reducing properties in people with type 2 diabetes, although the evidence is not definitive in these areas. Although the addition of soy to a regimen of exercise and diet may theoretically improve cardiovascular outcomes, this has not been scientifically proven. Some studies show an association between soy food consumption and lower risk of coronary heart disease in women, but further investigation is needed.
C
Osteoporosis, post-menopausal bone loss
It has been theorized that the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties) such as isoflavones may increase bone mineral density in post-menopausal women and reduce the risk of fractures. A small number of studies in this area report benefits, particularly in the lumbar spine (lower back). However, most studies have not been well designed or reported. Until better research is available, a firm conclusion cannot be drawn. Individuals at risk for osteoporosis should speak with a qualified healthcare provider about the therapeutic options for increasing bone mineral density.
C
Gall stones (cholelithiasis)
Due to limited human study, there is not enough evidence to recommend for or against the use of soy as a therapy in cholelithiasis. Further research is needed before a recommendation can be made.
C
Crohn's disease
Due to limited human study, there is not enough evidence to recommend for or against the use of soy as a therapy in preventing Crohn's Disease. Further research is needed before a recommendation can be made.
C
Cyclical breast pain
It has been theorized that the presence in soy of "phytoestrogens" (plant-based compounds with weak estrogen-like properties) such as isoflavones may be beneficial to pre-menopausal women with cyclical breast pain. However, due to limited human study, there is not enough evidence to recommend for or against the use of dietary soy protein as a therapy for this condition.
C
Type 2 diabetes
Several small studies have examined the effects of soy products on blood sugars in people with type 2 ("adult-onset") diabetes. Results are mixed, with some research reporting decreased blood glucose levels, and other trials noting no effects. Overall, research in his area is not well designed or reported, and better information is needed before the effects of soy on blood sugars can be clearly described.
C
High blood pressure
Due to limited human study, the effects of dietary soy on blood pressure are not clear. Further research is necessary before any recommendation can be made.
C
Kidney disease (chronic renal failure, nephrotic syndrome, proteinuria)
Due to limited human study, there is not enough evidence to recommend for or against the use of soy in the treatment of kidney diseases such as nephrotic syndrome. People with kidney disease should speak to their healthcare provider about recommended amounts of dietary protein, and should bear in mind that soy is a high protein food.
C
Obesity, weight reduction
Due to limited human study, there is not enough evidence to recommend for or against the use of soy for weight reduction. Further research is needed before a recommendation can be made.
C
Cognitive function
A recent study suggests that isoflavone supplementation in postmenopausal women may have favorable effects on cognitive function, particularly verbal memory. Further research is necessary before a firm conclusion can be drawn.
C
Stomach cancer
Preliminary study suggests that intake of soy products may be associated with a reduced risk of death from stomach cancer. Further investigation is needed before a conclusion can be drawn.
C
* Key to grades
A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use (it may not work);
F: Strong scientific evidence against this use (it likely does not work).
Uses based on tradition or theory
The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Anemia, anorexia, antifungal, antioxidant, antithrombotic, atherosclerosis, athletic endurance, attention deficit hyperactivity disorder (ADHD), autoimmune diseases, breast enlargement, cancer prevention (general), cystic fibrosis, diabetic neuropathy, fever, gastric cancer, gastrointestinal motility, headache, hepatitis (chronic), inflammation, insect repellant, lymphoma, memory enhancement, nosebleed (chronic), osteosarcoma, premature ovarian failure, rheumatoid arthritis, urinary tract cancer, vaginitis, vasoregulator.
Dosing
The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (over 18 years old)
High cholesterol : 30 to 50 grams of soy protein taken daily by mouth has been studied in people with high cholesterol. Isoflavone content has ranged from 60 to 80 milligrams per day. Cholesterol and low-density lipoprotein levels have been reduced in individuals using 28 grams daily of soy protein with a high isoflavone content, or with Abacor®, a brand that contains 26 grams of soy protein. There is limited study of soymilk (400 milliliters daily) in pre-menopausal women, with reported benefits on cholesterol levels.
Menopausal symptoms (hot flashes) : Isolated soy protein, such as Supro® (60 grams), soy flour (45 grams), and a range of isoflavone products have been studied. Doses of 50 to 75 milligrams of isoflavones have been used in research.
Diarrhea : In infants and young children (2-36 months-old), Hyprovit® formula, Isomil® formula, Nursoy® formula or powder, and Prosobee( formula taken by mouth have been studied. Due to potential safety concerns, a qualified healthcare provider should be consulted regarding the choice of infant formula. In adults, soy-derived diets and intake of soy-polysaccharide/fiber have been studied, although benefits are not clear.
Cancer and cancer prevention : Population and laboratory studies have examined levels of dietary soy intake. No specific doses can be recommended at this time.
Cardiovascular health : Studies have examined regular intake of dietary soy, or 40 to 80 milligrams of isoflavones taken by mouth daily.
Osteoporosis/post-menopausal bone loss : Isoflavones/isoflavone-rich soy (60 to 80 milligrams daily by mouth) and soy protein (for example, 40 grams daily of Supro 675®) have been studied.
Gall stones (cholelithiasis) : Dietary intake of soy has undergone limited study. Due to limited research in humans, no specific doses can be recommended at this time.
Crohn's disease : Due to limited research in humans, no specific doses can be recommended at this time.
Cyclic breast pain : A soy protein drink (17 grams of soy protein per 200 milliliters) has undergone limited study.
Diabetes : A fermented soybean-derived extract tea, various doses of soy protein (such as Abalon®), and up to 7 grams of daily soya fibers taken by mouth have undergone limited study in humans.
High blood pressure : Soymilk (1000 milliliters daily for three months) has undergone limited study.
Kidney disease/chronic renal failure : Soy-based diets have undergone limited study in people with kidney diseases such as the nephrotic syndrome. However, soy is a source of dietary protein, and low-protein diets may be more desirable in patients with kidney failure. People with kidney failure should speak with a doctor before making any dietary changes.
Obesity : A soy-derived diet has undergone limited study.
Children (under 18 years old)
Diarrhea : In infants and young children (2-36 months-old), Hyprovit® formula, Isomil® formula, Nursoy® formula or powder, and Prosobee® formula taken by mouth have been studied. Due to potential safety concerns, a qualified healthcare provider should be consulted regarding the choice of infant formula.
Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Allergies
Soy can act as a food allergen similar to milk, eggs, peanuts, fish, and wheat. The rate of soy allergy in children with positive skin tests has been reported as high as 6%. In limited research, soy has been well tolerated by most children with IgE-associated cow's milk allergy (CMA), although allergic cross-reactivity has occasionally been reported. Rare allergic reactions have been reported in human research, and two subjects withdrew from a cholesterol study due to suspected allergy to soy. In a study involving young adults with asthma, soy beverages were associated with an increased risk of asthma. Asthma-like breathing problems have also been associated with inhaling soybean dust.
Side Effects and Warnings
Soy has been a dietary staple in many countries for over 5,000 years, and is generally not regarded as having significant long-term toxicity. Limited side effects have been reported in infants, children, and adults.
Soy protein taken by mouth has been associated with stomach and intestinal difficulties such as bloating, nausea, and constipation. More serious intestinal side effects have been uncommonly reported in infants fed soy protein formula, including vomiting, diarrhea, growth failure and damage/bleeding of the intestine walls. Soy protein fed to infants recovering from acute gastroenteritis may cause persistent intestinal damage and diarrhea. People who experience intestinal irritation (colitis) from cow's milk may also react to soy formula.
Based on human case reports and animal research, decreased thyroid hormone and increased thyroid stimulating hormone (TSH) levels may occur during the use of soy formula in infants. This includes rare reports of goiter (enlarged neck due to increased thyroid size). Hormone levels have become normal again after stopping soy. Infants fed soy or cow's milk formula may also have higher rates of atopic eczema than infants who are breast-fed.
Acute migraine headache has been reported with the use of a soy isoflavone product. Based on animal research, damage to the pancreas may theoretically occur from regularly eating raw soybeans or soy flour/protein powder made from raw, unroasted, or unfermented beans.
The use of soy is often discouraged in patients with hormone-sensitive malignancies such as breast, ovarian, or uterine cancer, due to concerns about possible estrogen-like effects (which theoretically may stimulate tumor growth). Other hormone-sensitive conditions such as endometriosis may also theoretically be worsened. In laboratory studies, it is not clear if isoflavones stimulate or block the effects of estrogen, or both (acting as a "receptor agonist/antagonist"). Until additional research is available, patients with these conditions should be cautious and speak with a qualified healthcare practitioner before starting use.
It is not known if soy or soy isoflavones share the same side effects as estrogens, such as increased risk of blood clots. Preliminary studies suggest that soy isoflavones, unlike estrogens, do not cause the lining of the uterus (endometrium) to build up.
Pregnancy and Breastfeeding
Soy as a part of the regular diet is traditionally considered to be safe during pregnancy and breastfeeding, although scientific research is limited in these areas. The effects of high doses of soy or soy isoflavones in humans are not clear, and therefore are not recommended.
Recent study demonstrates that isoflavones, which may have estrogen-like properties, are transferred through breast milk from mothers to infants. High doses of isoflavones given to pregnant rats have resulted in tumors in female offspring, although this has not been tested in humans.
In one human study, male infants born to women who ingested soymilk or soy products during pregnancy experienced more frequent hypospadias (a birth defect in which the urethral meatus, the opening from which urine passes, is abnormally positioned on the underside of the penis). However, other human and animal studies have examined males or females fed soy formula as infants, and have not found abnormalities in infant growth, head circumference, height, weight, occurrence of puberty, menstruation, or reproductive ability.
Research in children during the first year of life has found that the substitution of soy formula for cow's milk may be associated with significantly lower bone mineral density. Parents considering the use of soy formula should speak with a qualified healthcare practitioner to make sure the appropriate vitamins and minerals are provided in the formula.
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