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Open Access 01-12-2017 | Study protocol

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

Authors: Laura E. McBreairty, Philip D. Chilibeck, Donna R. Chizen, Roger A. Pierson, Lindsay Tumback, Lauren B. Sherar, Gordon A. Zello

Published in: BMC Nutrition | Issue 1/2017

Abstract

Background

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.

Methods

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 < 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.

Discussion

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.

Trial registration

NCT01288638. Trial registered January 13, 2011.

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Title: 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
Authors: Laura E. McBreairty
Philip D. Chilibeck
Donna R. Chizen
Roger A. Pierson
Lindsay Tumback
Lauren B. Sherar
Gordon A. Zello
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: BMC Nutrition / Issue 1/2017
Electronic ISSN: 2055-0928
DOI: https://doi.org/10.1186/s40795-017-0142-6

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