1. The role of a pulse-based diet on infertility measures and metabolic syndrome risk: protocol of a randomized clinical trial in women with polycystic ovary syndrome
- Author
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Laura E. McBreairty, Lindsay Tumback, Roger A. Pierson, Lauren B. Sherar, Donna R. Chizen, Gordon A. Zello, and Philip D. Chilibeck
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Infertility ,medicine.medical_specialty ,Polycystic ovary syndrome ,Metabolic syndrome ,Randomized controlled trial ,Pulses ,endocrine system diseases ,Endocrinology, Diabetes and Metabolism ,Population ,Medicine (miscellaneous) ,030209 endocrinology & metabolism ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Insulin resistance ,Internal medicine ,Hyperinsulinemia ,Medicine ,education ,National Cholesterol Education Program ,Gynecology ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Nutrition and Dietetics ,business.industry ,Public Health, Environmental and Occupational Health ,medicine.disease ,Polycystic ovary ,Therapeutic Lifestyle Changes ,business - Abstract
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 (p
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