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RCT·obstetrics and gynecology, endocrinology, nutrition, clinical nutrition, dietetics·PMC10410796

A comparison of the portfolio low-carbohydrate diet and the ketogenic diet in overweight and obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial

Trials · 4 authors, 3 centres

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TL;DR

Participants will be randomly assigned to one of the two diets for 8 weeks.

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Participants will be randomly assigned to one of the two diets for 8 weeks. The primary outcome is effectiveness in improving PCOS symptoms, measured by weight loss. Secondary outcomes include BMI, body composition, insulin and sex hormone levels, lipid profile, glucose levels, HOMA-IR, physical activity, quality of life, and Ferriman-Gallwey score. The study is designed to address the lack of consensus on an optimal diet for PCOS management. Implications are that the results could provide evidence-based dietary recommendations for women with PCOS, but no results are reported as this is a protocol.

STUDY TYPE

RCT

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obstetrics and gynecology

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ORIGINAL PAPER

PMC10410796

A comparison of the portfolio low-carbohydrate diet and the ketogenic diet in overweight and obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial

Trials

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ABSTRACT

Abstract Background Polycystic ovary syndrome (PCOS) is one of the most frequent endocrine disorders among women of fertile age. Women with PCOS manifest clinical symptoms like menstrual dysfunction, hirsutism, insulin resistance, and hyperinsulinemia. As excessive amounts of insulin levels directly increase ovarian production of androgens, hyperinsulinemia and insulin resistance are considered as the pathogenesis factors of PCOS. The portfolio low-carbohydrate diet (PLCD) is a plant-based diet with 40% carbohydrates combined with five cholesterol-lowering foods and nutrients. On the other hand, the ketogenic diet (KD) is a nutritional protocol with 10% carbohydrates. The purpose of this study is to determine whether PLCD or KD is more effective in alleviating PCOS symptoms. Methods Forty-six overweight or obese women diagnosed with PCOS will be randomly stratified to receive either PLCD or KD for 8 weeks. Measures related to anthropometric and body composition, glucose, and insulin level, HOMA-IR, sex hormones, lipid profile, quality of life, dietary intake, physical activity, and Ferriman-Gallwey score of all participants will be accessed before and after the intervention. Discussion Since the first line treatment of PCOS is lifestyle adjustment including diet control and exercise, there has not been determined the optimal diet for this population of women yet. Hence, the goal of conducting this study is to determine whether the PLCD or the KD could have more advantageous effects on attenuating PCOS manifestations. The result of this investigation will give us new insight into curing this disease and will provide evidence-based recommendations for prescribing an optimal diet for PCOS women. Trial registration IRCT20200912048693N3, Trial registered 2022–12-14. https://www.irct.ir/trial/67548 Keywords: Polycystic ovary syndrome, Portfolio low-carbohydrate diet, Ketogenic diet

CITATION EXPORT

Maryam Sharifi Najafabadi, Jalal Moludi, Yahya Salimi et al.. A comparison of the portfolio low-carbohydrate diet and the ketogenic diet in overweight and obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials. (2023). https://doi.org/10.1186/s13063-023-07569-6

AUTHORS

4 · 3 CENTRES

Maryam Sharifi Najafabadi, Jalal Moludi, Yahya Salimi, Amir Saber

1Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran
2Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Across From Farabi Hospital, Kermanshah University of Medical Sciences, Isar Sq., P.O. Box 6719851552, Kermanshah, Iran
3Social Development & Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran