The Effect of Resistant Dextrin as a Prebiotic on Metabolic Parameters and Androgen Level in Women with Polycystic Ovarian Syndrome: A Randomized, Triple-blind, Controlled, Clinical trial

Abstract

Introduction: Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders that can lead to a variety of complications. Studies reveal that a healthy diet is the most effective way for treating the risk factors associated with metabolic disorders and place greater emphasis on the consumption of prebiotic foods. The present study aims to determine the effect of prebiotic on serum DHEA-s (dehydroepiandrosterone sulfate), free-testosterone and hirsutism (primary outcomes) and lipid profile, FBS (Fasting Blood Glucose), hsCRP (High Sensitivity C-Reactive Protein), anthropometric indices and menstrual cycle statue (secondary outcomes) in women with PCOS. Methods: This randomized, controlled, triple-blind, clinical trial was conducted on 62 women aged 18-45 in Tabriz. The participants were divided into an intervention group and a control group using block randomization. The intervention group consumed 20 g of resistant dextrin dissolved in a glass of water and the control group 20 g of maltodextrin also dissolved in a glass of water on a daily basis for three months. To measure the serum lipid profile, FBS, hsCRP, DHEA-s and free-testosterone before and three months after the intervention, 5-ml blood samples were collected from the participants and analyzed using the ELISA method. The Ferriman-Gallwey scale for assessing hirsutism and a checklist for assessing menstrual cycle statue (interval of menstrual cycle and the menstrual cycle duration) were completed before and three months after the intervention. Weight, waist circumference, and hip circumference were measured before, three months and six months after intervention.A general linear model, Chi square and independent t-tests were used to analyze the data. Results: No statistically significant differences were observed between the two groups in terms of sociodemographic characteristics. Three months after the intervention, based on the ANCOVA and after adjusting for the baseline values, the mean serum levels of LDL-C (Adjusted Mean Difference= -29.79; 95% CI= -43.37 to -16.21; P< 0.001), triglyceride (-38.50; -59.73 to -17.28; P= 0.001), total cholesterol (-29.98; -40.14 to -19.82; P< 0.001), FBS (-11.24; -15.43 to -7.06; P< 0.001), hsCRP (-1.75; -2.92 to -0.57; P= 0.004), DHEA-S (-0.7; -1.34 to -0.13; P=0.017), free testosterone (-0.32; -0.56 to -0.08; P=0.010), the mean of hirsutism score (-1.4; -2.19 to -0.79; P<0.001), mean of waist circumference (-5.35; -6.80 to -3.90; P<0.001), hip circumference(-5.45; -7.24 to -3.66; P<0.001), weight (-3.37; -4.41 to -2.34; P<0.001), BMI (-1.29; -1.68 to -0.89; P<0.001) and menstrual cycles interval (-14.1; -21.3 to -6.9; P<0.001) revealed a statistically significant decrease in the intervention group compared to the placebo group, while the mean serum HDL-C showed a statistically significant increase in this group compared to the placebo group (5.82; 2.27 to 9.37; P= 0.002). Conclusion: Prebiotic consumption have a positive effect on lipid profile, FBS, hsCRP, DHEA-s, free-testestrone, anthropometric indices, hirsutism and menstrual statue in women with PCOS.