Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Polycystic Ovary Syndrome
• Interventions: Other: Pulse-based diet; Other: TLC diet

• Registration Number: NCT01288638
• Lead Sponsor: University of Saskatchewan

Brief Summary

The purpose of our study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic exercise for improving PCOS disease features and risk factors for metabolic syndrome. We would like to determine the therapeutic effects of a lifestyle program that combines a pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic syndrome.

Detailed Description

To date, we have developed the pulse-based and meat-based healthy meals following Therapeutic Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We have been recruiting and enrolling participants into the study with our few set of participants having completed the 4 month intervention. Baseline data have been also collected on all participants assessed for PCOS. Preliminary measurements on POCS characteristics, baseline dietary and exercise habits of women with PCOS will be soon available.

This study involves an intervention comparing a diet containing pulses (i.e. beans, peas, chick peas, lentils) to a diet recommended by the National Cholesterol Education Program (NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women in the pulse-diet group have completed the intervention, nine women in the group receiving the NCEP diet have completed the intervention, four women are currently enrolled on the pulse diet and two women are currently enrolled on the NCEP diet.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2017-07
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

Inclusion Criteria

• Female
• Diagnosis of PCOS
• Aged 18-35 years

Exclusion Criteria

• Taking birth control or fertility medications
• Medical conditions that limit exercise or which limit consumption of a pulse-based diet (allergies or intolerances)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse-based diet	Pulse-based diet	The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.
TLC diet	TLC diet	Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses.

Primary Outcome Measures

Name	Time	Method
Change in polycystic ovary syndrome disease measures from baseline	At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up

Secondary Outcome Measures

Name	Time	Method
Change in metabolic syndrome disease measures from baseline	At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada