Effects of three medical nutrition therapies on nutritional metabolism and intestinal flora in overweight/obese with polycystic ovary syndrome (PCOS): Study protocol for a randomised controlled trial.

Background and objectives: Observational studies have shown that energy restriction could be beneficial for controlling bodyweight in patients with polycystic ovary syndrome (PCOS). We aim to compare the effects of a high-protein diet (HPD), a high-protein and high-dietary fiber diet (HPHFD), and a calorie-restricted diet (CRD) on metabolic health and gut microbiota in overweight/obese PCOS patients.

Methods and study design: We will enroll a total of 90 overweight/obese PCOS patients into this eight-week open-label randomised controlled trial. Participants will be randomly assigned to three groups: CRD group (energy coefficient 20 kcal/kg.day, water ≥1500 mL, 0.8-1.2 g/kg protein, carbohydrate energize 55-60%, and fat energize 25-30%), HDP group (energy coefficient 20 kcal/kg.day, water ≥1500 mL, and 1.5-2.0 g/kg protein) and HPHFD group (based on the high protein diet with 15 g more dietary fiber supplement). The primary outcome is body weight, body fat percentage, and lean body mass. The secondary outcomes will include changes in blood lipids, inflammation, glucose tolerance, blood pressure, and gut microbiota compositions. Between-group differences in adiposity measurements at baseline will be compared using one-way analysis of variance (ANOVA) or Kruskal-Wallis test when appropriate. Within-group difference after 8-week intervention will be compared using paired t-test or Wilcoxon signed rank test. Between-group differences in adiposity measurements after 8-week diet intervention will be compared using linear mixed model and ANCOVA. The gut microbiota will be analyzed using 16S amplicon sequencing and the sequencing data will be analyzed using the standardized QIIME2 piperline.