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.

IF 1.3 4区 医学 Q4 NUTRITION & DIETETICS
Pan Dou, Zhen-Huang Zhuang, Yi-Min Zhao, Yue-Xin Yang, Ting-Ting Zhang, Yang Xu, Qing Xue, Tao Huang
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Abstract

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.

三种药物营养疗法对超重/肥胖合并多囊卵巢综合征(PCOS)患者营养代谢和肠道菌群的影响:一项随机对照试验的研究方案
背景和目的:观察性研究表明,能量限制可能有利于控制多囊卵巢综合征(PCOS)患者的体重。我们的目的是比较高蛋白饮食(HPD)、高蛋白和高膳食纤维饮食(HPHFD)和热量限制饮食(CRD)对超重/肥胖多囊卵巢综合征患者代谢健康和肠道微生物群的影响。方法和研究设计:我们将招募90名超重/肥胖多囊卵巢综合征患者参加为期8周的开放标签随机对照试验。参与者将被随机分为三组:CRD组(能量系数20 kcal/kg)。天,水≥1500 mL,蛋白质0.8-1.2 g/kg,碳水化合物能量55-60%,脂肪能量25-30%),HDP组(能量系数20 kcal/kg。每天,水≥1500 mL,蛋白质1.5 ~ 2.0 g/kg)和HPHFD组(在高蛋白饮食的基础上,增加膳食纤维15 g)。主要结果是体重、体脂率和瘦体重。次要结局包括血脂、炎症、葡萄糖耐量、血压和肠道微生物群组成的变化。基线肥胖测量的组间差异将采用单因素方差分析(ANOVA)或Kruskal-Wallis检验进行比较。干预8周后的组内差异采用配对t检验或Wilcoxon符号秩检验比较。采用线性混合模型和ANCOVA比较8周饮食干预后肥胖测量的组间差异。采用16S扩增子测序对肠道菌群进行分析,采用标准化QIIME2流水线对测序数据进行分析。
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来源期刊
CiteScore
2.50
自引率
7.70%
发文量
58
审稿时长
6-12 weeks
期刊介绍: The aims of the Asia Pacific Journal of Clinical Nutrition (APJCN) are to publish high quality clinical nutrition relevant research findings which can build the capacity of clinical nutritionists in the region and enhance the practice of human nutrition and related disciplines for health promotion and disease prevention. APJCN will publish original research reports, reviews, short communications and case reports. News, book reviews and other items will also be included. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer-reviewed by at least two anonymous reviewers and the Editor. The Editorial Board reserves the right to refuse any material for publication and advises that authors should retain copies of submitted manuscripts and correspondence as material cannot be returned. Final acceptance or rejection rests with the Editorial Board
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