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File: Soy (Glycine max) Postmenopause Obesity HC 061112-434 Date: October 14, 2011 RE: Soy Isoflavones Plus Diet and Physical Exercise Have Beneficial Health Effects on Obese, but Otherwise Healthy, Postmenopausal Women Llaneza P, Gonzlez C, Fernandez-Iarrea J, et al. Soy isoflavones, diet and physical exercise modify serum cytokines in healthy obese postmenopausal women. Phytomedicine. 2011 Feb 15;18(4):245-250. The hormonal changes due to menopause may cause women to gain weight around the abdomen, rather than the hips and thighs. Excess weight increases the risk of high cholesterol, high blood pressure, and type 2 diabetes; all conditions that increase the risk of heart disease and stroke. Genetics and lifestyle changes also play a role. Many potential health benefits have been linked to intake of soy (Glycine max) products, according to epidemiological investigations. In a previous study,1 the authors showed that 40 mg of soy isoflavones together with a Mediterranean diet and exercise reduced insulin resistance in postmenopausal women. In this multicenter, randomized, longitudinal, prospective cohort trial, they studied obese, but otherwise healthy, postmenopausal women to see whether there could be a benefit to this population as well. Subjects included 87 obese postmenopausal women (body mass index [BMI] >30 kg/m2, aged 50-64 years) who had intact uterus and ovaries, were sexually active, and did not use hormone replacement therapy. Menopause was established as 1 year since the last menstrual period. Subjects were randomly assigned to either a 1200 kcal diet plus exercise (control group) or a 1200 kcal diet, exercise, and daily oral intake of Fisiogen soy isoflavone extract (soy group; Lukoll SAC; Lima, Peru) for 6 months. Fisiogen consisted of 200 mg of soy (60.8 mg genistein, 16 mg daidzein, and 3.2 mg glycitein; equivalent to 80 mg of isoflavones). Subjects received oral and written instruction on how to maintain a 1200 calorie diet and physical activity program of at least 1 hour of walking per day. Compliance was encouraged and assessed at 3- and 6-month follow-ups as well as brief check-ins.

The menopausal Kupperman index was used to capture changes in menopausal symptoms. The Cervantes Scale was used to evaluate Health Related Quality of Life (HR-QoL). Fasting blood samples were taken at baseline and also after 6 months and were analyzed for leptin, adiponectin, tumor necrosis factor-alpha (TNF-), C-reactive protein, homocysteine, glucose, insulin, and serum estrogen and lipids. There was no difference in anthropometric or blood measures between the 2 groups. Only 70 subjects completed the protocol (drop-out rate: 15.9% in the control group and 23.3% in the soy group), mostly due to problems adhering to the protocol rather than adverse events. In both the control and soy groups, mean serum leptin (P=0.026 and P=0.047, respectively) and TNF- levels (P=0.003 and P<0.001, respectively) declined after 6 months. In the soy group, there was a significant increase in mean serum levels of adiponectin, a protein hormone produced and secreted exclusively by adipocytes (fat cells) that regulates the metabolism of lipids and glucose (P=0.041). Regression analysis showed that the change in leptin could be explained by treatment and low-density lipoprotein cholesterol (LDL-C) levels (F=8.6, P<0.0001, adjusted R square=0.207). The change in adiponectin could be explained by time of treatment (F=8.84, P0.5, adjusted R square=0.08) and the change in TNF- could be explained by treatment, LDL-C, and time of treatment (F=12.77, P0.001, adjusted R square=0.371). The Kupperman index decreased significantly in both the control and soy groups (P<0.001 and P=0.03, respectively). There were no between-group differences in the HR-QoL total mean scores. The authors deduced that adherence to the protocol was difficult for the subjects because the 1200 calorie diet coupled with 1 hour of walking should have resulted in a calorie deficit and weight loss, but it did not. The decrease in leptin and increase in adiponectin were beneficial as leptin is positively and adiponectin negatively correlated with overall parameters of obesity. TNF- is pro-inflammatory and increases with weight gain, and therefore its reduction in this population should also be beneficial. The authors purported that the lack of a concurrent difference in insulin or homeostasis model assessment-insulin resistance (HOMA-IR) was probably because more than 6 months of treatment would be necessary to cause changes in glucose metabolism. The authors conclude that, "Diet, physical exercise and daily oral intake of a soy isoflavones extract (Fisiogen) have a beneficial effect on serum leptin, adiponectin and TNF- in healthy obese postmenopausal women after 6 months of treatment." They state that larger and longer studies are needed to corroborate their results.

David Levine
Reference 1 Llaneza P, Gonzalez C, Fernandez-Iarrea J, et al. Soy isoflavones, Mediterranean diet, and physical exercise in postmenopausal women with insulin resistance. Menopause. 2010 Mar;17(2):372-378. Referenced article available to HerbClip e Service Recipients.

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