Soy isoflavone supplements had a beneficial effect on the metabolic status of patients with polycystic ovary syndrome (PCOS), including insulin levels, androgen levels, and triglycerides, according to Iranian researchers.
In the randomized, double-blind, clinical trial of 70 women between the ages of 18 and 40, led by Mehri Jamilian, PhD, of Arak University of Medical Sciences, all participants, as assessed by the Rotterdam criteria, were diagnosed with PCOS and separated into a placebo (n=35) and an intervention group (n=35).
As explained in the study in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism, the trial examined the impact of soy isoflavone supplements on several criteria relating to overall metabolic status -- primarily biomarkers for insulin resistance and free androgen index levels, inflammation markers, oxidative stress levels, and lipid profiles.
"There is growing interest in how adding soy to the diet can help address metabolic syndrome and related health conditions," the study's coauthor, Zatollah Asemi, PhD, of Kashan University of Medical Sciences, noted in a press release. "Our findings indicate consuming soy isoflavone regularly may help women with PCOS improve their metabolic and cardiovascular health."
The authors gave 50 milligrams a day to the women in the intervention group over a 12-week trial period. Using both clinical and biochemical measures to test the effects of soy isoflavone supplements, Jamilian and Asemi used fasting blood samples to measure the chemical changes in the variables relating to metabolic status as well as a modified Ferriman-Gallwey scoring system to assess changes in alopecia and acne.
There were no adverse effects reported during the study.
"Our research found that women who have PCOS may benefit from incorporating soy isoflavones in their diets," Asemi said. "In the first study to examine the connection, we found women who consumed soy isoflavones regularly saw improvement in biological markers that reflect how effectively the body utilizes insulin to process sugars and had reduced levels of harmful cholesterol."
Consuming soy had an overall beneficial impact on the metabolic status of the women with PCOS in the study. The intervention group had a decrease in insulin levels (-1.2 ± 4.0 versus +2.8 ± 4.7 μIU/mL), as well as an increase in insulin sensitivity (+0.0009 ± 0.01 versus -0.01 ± 0.03).
Triglyceride panels were also significantly reduced in the soy group (-13.3 ± 62.2 versus +10.3 ± 24.5 mg/dL). Additionally, the soy intervention group saw a significant decrease in the free androgen index (-0.03 ± 0.04 versus +0.02 ± 0.03).
Secondary analysis examined the impact of soy isoflavones on inflammatory markers and oxidative stress levels. Compared with the placebo group, the results showed that soy intervention had no significant impact on these factors.
The researchers also found that when assessing clinical measures after 12 weeks of soy intervention, there was a beneficial impact in decreasing alopecia among women with PCOS (31.6% versus 4.3%). The second clinical measure, acne, had no significant change after soy consumption (31.8% versus 13%).
While past research suggested the benefits of soy in terms of insulin levels and glycemic indexes, this study is unique in that the authors identified a benefit in a predisposed, at-risk group, they explained.
"Previous studies have reported a positive impact of phytoestrogens on the glycoinsulinemic assessment of postmenopausal women, obese subjects, and patients with type 2 diabetes mellitus," Asemi told MedPage Today via email. "Therefore, based on existing evidence, we decided to evaluate the beneficial effects of soy isoflavones on PCOS patients."
Among the study limitations were that it was not possible to measure the impact of soy intake on estrogen levels in women with PCOS, which could further influence overall metabolic status. In addition, while the study was successful in measuring insulin levels, it was not possible, due to a lack of funding, to obtain the most accurate levels of free androgen index, the authors noted, adding that they were unable to confirm their data obtained via enzyme-linked immunosorbent assay against liquid chromatography-tandem mass spectrometry.
Regarding future studies, Asemi said that the determination of appropriate dosage and duration intervention of soy isoflavones among PCOS patients is the likely next step for the team. "In addition, the beneficial effects of soy isoflavones would be compared with soy milk or other soy products in PCOS patients," he said.
The study was funded by a grant from the Vice Chancellor for Research, Kashan University of Medical Sciences and Arak University of Medical Sciences, and the government of Iran.
The authors disclosed having no relevant relationships with industry.
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