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Beneficial Effects of Soy Phytoestrogen Intake In Clinical Care/Education/Nutrition ORIGINAL ARTICLE Beneficial Effects of Soy Phytoestrogen Intake in Postmenopausal Women With Type 2 Diabetes 1 1,4 VIJAY JAYAGOPAL, MRCP PAUL E. JENNINGS, FRCP very similar degrees of hyperglycemia, the 1 1 PAULA ALBERTAZZI, MRCOG DAVID A. HEPBURN, FRCP Japanese-Americans with type 2 diabetes 2 1 ERIC S. KILPATRICK, MRCPATH STEPHEN L. ATKIN, FRCP 3 showed significantly higher levels of ELAINE M. HOWARTH, MSC plasma insulin after a 75-g oral glucose tolerance test (OGTT) than Japanese with diabetes (6,8), and BMI correlated with insulin levels only for the Japanese- OBJECTIVE — Phytoestrogen consumption has been shown to reduce risk factors for car- American men (8). This observation sug- diovascular disease. Type 2 diabetes confers an adverse cardiovascular risk profile particularly in gested a greater degree of insulin women after menopause. The aim of this study was to determine whether a dietary supplement resistance among the Japanese-Americans with soy protein and isoflavones affected insulin resistance, glycemic control, and cardiovascular and that factors other than BMI were re- risk markers in postmenopausal women with type 2 diabetes. sponsible for the difference in plasma in- sulin levels between the two groups (9). RESEARCH DESIGN AND METHODS — A total of 32 postmenopausal women with Soy is a staple in the diet of the Japanese diet-controlled type 2 diabetes completed a randomized, double blind, cross-over trial of dietary supplementation with phytoestrogens (soy protein 30 g/day, isoflavones 132 mg/day) versus population, and consumption of soy has placebo (cellulose 30 g/day) for 12 weeks, separated by a 2-week washout period. been shown to have an inverse relation- ship with mortality from CVD. These le- RESULTS — Compliance with the dietary supplementation was Ͼ90% for both treatment gumes contain complex carbohydrates, phases. When compared with the mean percentage change from baseline seen after 12 weeks of vegetable protein, soluble fibers, oligosac- placebo, phytoestrogen supplementation demonstrated significantly lower mean values for fast- charides, minerals, and phytoestrogens, ing insulin (mean Ϯ SD 8.09 Ϯ 21.9%, P ϭ 0.006), insulin resistance (6.47 Ϯ 27.7%, P ϭ Ϯ ϭ Ϯ ϭ particularly the isoflavones genistein and 0.003), HbA1c (0.64 3.19%, P 0.048), total cholesterol (4.07 8.13%, P 0.004), LDL cholesterol (7.09 Ϯ 12.7%, P ϭ 0.001), cholesterol/HDL cholesterol ratio (3.89 Ϯ 11.7%, P ϭ daidzein, that may be beneficial in the 0.015), and free thyroxine (2.50 Ϯ 8.47%, P ϭ 0.004). No significant change occurred in HDL management of diabetes (10). In vitro cholesterol, triglycerides, weight, blood pressure, creatinine, dehydroepiandrosterone sulfate, studies have shown isoflavones to have androstenedione, and the hypothalamic-pituitary-ovarian axis hormones. antidiabetic properties such as inhibiting intestinal brush border uptake of glucose, CONCLUSIONS — These results show that dietary supplementation with soy phytoestro- having ␣-glucosidase inhibitor actions, gens favorably alters insulin resistance, glycemic control, and serum lipoproteins in postmeno- pausal women with type 2 diabetes, thereby improving their cardiovascular risk profile. and also demonstrating tyrosine kinase inhibitory properties (11–13). Diets con- Diabetes Care 25:1709–1714, 2002 taining soy protein rich in isoflavones have been shown to improve insulin re- sistance in ovariectomized cynomolgus ardiovascular diseases (CVDs), es- menopausal estrogen depletion (4) and monkeys (14) and to reduce insulin levels pecially coronary heart disease and increased insulin resistance (5) may con- in healthy postmenopausal women C cerebrovascular disease, are the tribute to the high risk of accelerated CVD (15,16). Previous studies on the effects of leading causes of death in women (1). in women with type 2 diabetes. using a soy-based diet in individuals with Type 2 diabetes increases the risk of death Epidemiological data suggest that in diabetes (17–20) have been performed on from CVD by two- to fourfold (2), and Japanese-Americans in Seattle, WA, the a heterogenous population using differing women with diabetes are four times more prevalence of type 2 diabetes is four times soy preparations, and there are few data likely to die from CVD than men (3). Post- that in Japanese in Tokyo (6,7). Despite focusing specifically on the effect of soy ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● phytoestrogens on postmenopausal From the 1Department of Medicine, University of Hull, Hull, U.K.; the 2Department of Clinical Biochemistry women with type 2 diabetes. This double- and Immunology, Hull Royal Infirmary, Hull, U.K.; the 3Department of Applied Statistics, University of Hull, blind, cross-over, placebo-controlled 4 Hull, U.K.; and the Department of Medicine, York District General Hospital, York, U.K. study was undertaken to determine the Address correspondence and reprint requests to Dr. Vijay Jayagopal, Michael White Centre for Diabetes and Endocrinology, Brocklehurst Building, Hull Royal Infirmary, 220-236, Anlaby Road, Hull, HU3 2RW, effect of dietary supplementation with U.K. E-mail: [email protected]. 30 g of soy proteins containing 132 mg of Received for publication 18 March 2002 and accepted in revised form 1 July 2002. phytoestrogen on indexes of glycemic Abbreviations: CVD, cardiovasular disease; HOMA-IR, insulin resistance measured by Homeostasis control, insulin resistance, and cardiovas- Model Assessment; OGTT, oral glucose tolerance test. A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion cular risk in postmenopausal women with factors for many substances. diet-controlled type 2 diabetes. DIABETES CARE, VOLUME 25, NUMBER 10, OCTOBER 2002 1709 Soy phytoestrogen intake in postmenopausal women with type 2 diabetes RESEARCH DESIGN AND during the placebo phase. The blood Synchron LX20 analyzer (Beckman- METHODS pressure readings for these women were Coulter, High Wycombe, U.K.). LDL cho- excluded from the analysis. lesterol was measured using the Subjects Friedewald equation. Plasma glucose was A total of 40 postmenopausal women Study design measured using a Synchron LX20 ana- with type 2 diabetes were screened for A randomized, double-blind, placebo- lyzer (Beckman-Coulter), and serum in- inclusion in the study. Women were con- controlled cross over study was under- sulin was assayed using a competitive sidered postmenopausal if menstrual pe- taken. A total of 17 women were initially chemiluminescent immunoassay per- riods had been absent for Ͼ1 year and assigned to placebo and 16 women were formed using the DPC Immulite 2000 an- follicle-stimulating hormone level was el- assigned to soy for 12 weeks. After a alyzer (Euro/DPC, Llanberis, U.K.). The evated. Women with a fasting venous 2-week washout period, the participants coefficient of variation of this method was plasma glucose concentration Ͼ7.0 received the alternative treatment for an 8%, calculated using duplicate study sam- mmol/l or a 2-h postprandial concentra- additional 12 weeks. The soy preparation ples. The analytical sensitivity was 2 ␮U/ tion Ͼ11.1 mmol/l after a 75-g OGTT (Essential Nutrition, Brough, U.K.) con- ml, and there was no stated cross- were recruited for the study. Exclusion tained 30 g of isolated soy protein with reactivity with proinsulin. The insulin criteria included any secondary cause of 132 mg of isoflavones. The proportions of resistance was calculated using the Ho- hyperglycemia, current or previous (in genistein, daidzein, and glycitein aver- meostasis Model Assessment method the preceding 6 months) use of estrogen aged 53, 37, and 10%, respectively, with (HOMA-IR ϭ (Insulin ϫ glucose)/22.5) therapy, treatment with insulin or oral hy- 95% of the isoflavones present as their (21). Serum luteinizing hormone, follicle- poglycemic agents, untreated hypothy- glucoside conjugates. The product was stimulating hormone, testosterone, estra- roidism, history of drug or alcohol abuse, completely devoid of soluble fiber and diol, triiodothyronine, free thyroxine, and history of breast or uterine cancer. each sachet provided 243 kcal. The con- and thyroid-stimulating hormone were A total of 33 subjects were eligible for trol supplement consisted of an identical measured on an Architect analyzer (Ab- inclusion in the study: age (mean Ϯ SD) sachet containing 30 g of pure microcrys- bott Laboratories, Maidenhead, U.K.). 62.5 Ϯ 6.77 years, BMI (kg/m2) 32.2 Ϯ talline cellulose (Emcocel; Penwest Phar- Sex hormone–binding globulin was mea- 5.0, time from diagnosis of type 2 diabetes maceuticals, Patterson, NY) of no sured using the DPC Immulite 2000 Ϯ 2.6 2.7 years. All subjects received ad- significant calorific content. Patients were analyzer (Euro/DPC) and HbA1c was vice on a diabetes diet from a registered instructed to maintain an isocaloric diet. measured on a Diabetes Control and dietitian before randomization. At the The randomization was performed by the Complications Trial (DCCT)-aligned HA- randomization visit, all subjects were ad- supplying company with a random num- 8140 analyzer (A. Menarini Diagnostics, vised to maintain their diabetes diet and ber generating table. A copy of the ran- Berkshire, U.K.) using the manufacturer’s level of physical activity throughout the domization code was kept secure by the recommended protocol. Routine bio- study and were also instructed by inter- hospital pharmacy and was available to chemistry and liver function tests were view and through an information
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