McBreairty Laura E, Chilibeck Philip D, Chizen Donna R, Pierson Roger A, Tumback Lindsay, Sherar Lauren B, Zello Gordon A
1College of Pharmacy and Nutrition, University of Saskatchewan, 107 Wiggins Road, Saskatoon, SK S7N 5E5 Canada.
2College of Kinesiology, Physical Activity Complex, University of Saskatchewan, 87 Campus Drive, Saskatoon, SK S7N 5B2 Canada.
BMC Nutr. 2017 Mar 7;3:23. doi: 10.1186/s40795-017-0142-6. eCollection 2017.
Polycystic Ovary Syndrome (PCOS) is an endocrine disorder in women of reproductive age with an estimated prevalence of 5-20% of premenopausal women. The clinical symptoms common to PCOS include menstrual dysfunction, hyperandrogenemia, hirsutism, polycystic ovaries, insulin resistance, and hyperinsulinemia. Women with PCOS are at an increased risk of infertility, obesity and type 2 diabetes mellitus. Insulin resistance and hyperinsulinemia are believed to be key contributing factors to the pathogenesis of PCOS; excessive amounts of insulin are directly associated with the increased ovarian production of androgens and metabolic features of PCOS. Pulse-based diets (e.g., beans, chickpeas) are associated with improved glycemic control and have insulin lowering effects. The purpose of this study is to determine whether a pulse-based diet is more effective than the diet recommended by the National Cholesterol Education Program. The primary outcomes of this study are disease measures related to PCOS, with secondary outcomes including measures related to metabolic syndrome.
Women with symptoms of PCOS will be recruited for the study and a diagnosis of PCOS will be determined by an obstetrician-gynecologist. Women with PCOS will be randomly assigned to receive either a pulse-based diet or the National Cholesterol Education Program therapeutic lifestyle changes (TLC) diet for 16 weeks while participating in an aerobic exercise program. One hundred participants will be required (drop-out rate of 32%) for recruitment to provide 80% power for detecting a significant difference in fasting glucose ( < 0.05). Measures related to infertility, metabolic syndrome, quality of life, dietary intake and physical activity will be assessed pre- and post-intervention with follow up assessment at 6- and 12-months post-intervention.
Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age and there is currently no recommended diet for this population of women. The multidisciplinary nature of this study, including determination of measures related to metabolic syndrome, infertility and physical activity provide a comprehensive assessment of any benefits associated with a pulse-based diet in women with PCOS. The results of this study will help in providing evidence-based recommendations for the optimum diet to reduce symptoms associated with PCOS.
NCT01288638. Trial registered January 13, 2011.
多囊卵巢综合征（PCOS）是一种发生于育龄女性的内分泌紊乱疾病，据估计，在绝经前女性中患病率为5%-20%。PCOS常见的临床症状包括月经功能紊乱、高雄激素血症、多毛、多囊卵巢、胰岛素抵抗和高胰岛素血症。患有PCOS的女性不孕、肥胖和2型糖尿病的风险增加。胰岛素抵抗和高胰岛素血症被认为是PCOS发病机制的关键促成因素；过量的胰岛素与卵巢雄激素分泌增加及PCOS的代谢特征直接相关。以豆类（如豆子、鹰嘴豆）为主的饮食与改善血糖控制相关，且具有降低胰岛素的作用。本研究的目的是确定以豆类为主的饮食是否比美国国家胆固醇教育计划推荐的饮食更有效。本研究的主要结局是与PCOS相关的疾病指标，次要结局包括与代谢综合征相关的指标。
将招募有PCOS症状的女性参与本研究，由妇产科医生确定PCOS诊断。患有PCOS的女性将被随机分配接受以豆类为主的饮食或美国国家胆固醇教育计划治疗性生活方式改变（TLC）饮食，为期16周，同时参加有氧运动计划。招募时需要100名参与者（失访率为32%），以提供80%的检验效能来检测空腹血糖的显著差异（<0.05）。在干预前后以及干预后6个月和12个月进行随访评估时，将评估与不孕、代谢综合征、生活质量、饮食摄入和身体活动相关的指标。
多囊卵巢综合征是育龄女性中最常见的内分泌紊乱疾病，目前对于这类女性没有推荐的饮食方案。本研究的多学科性质，包括确定与代谢综合征、不孕和身体活动相关的指标，为评估以豆类为主的饮食对患有PCOS的女性的任何益处提供了全面的评估。本研究的结果将有助于为减少PCOS相关症状的最佳饮食提供循证建议。
NCT01288638。于2011年1月13日注册。
