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

Metabolic Syndrome Clinical Trial

Official title:

A Lifestyle Intervention for Women With Polycystic Ovary Syndrome: The Role of a Pulse-Based Diet and Aerobic Exercise on Infertility Measures and Metabolic Syndrome Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288638
• Other study ID #: Pulse-PCOS
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: October 13, 2017
• Start date: January 2011
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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