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

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ClinicalTrials.gov Identifier: NCT01288638
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : October 17, 2017
Sponsor:
Collaborators:
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

January 13, 2011
February 2, 2011
October 17, 2017
January 2011
July 2017   (Final data collection date for primary outcome measure)
Change in polycystic ovary syndrome disease measures from baseline [ Time Frame: At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up ]
Change in polycystic ovary syndrome disease measures from baseline [ Time Frame: At baseline, after TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up ]
Complete list of historical versions of study NCT01288638 on ClinicalTrials.gov Archive Site
Change in metabolic syndrome disease measures from baseline [ Time Frame: At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up ]
Change in metabolic syndrome disease measures from baseline [ Time Frame: At baseline, after TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up ]
Not Provided
Not Provided
 
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise
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
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Metabolic Syndrome
  • 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.
  • Other: 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.
  • Experimental: 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.
    Intervention: Other: Pulse-based diet
  • Placebo Comparator: 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.
    Intervention: Other: TLC diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
166
August 2017
July 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01288638
Pulse-PCOS
Yes
Not Provided
Not Provided
Phil Chilibeck, University of Saskatchewan
University of Saskatchewan
  • Agriculture and Agri-Food Canada
  • Saskatchewan Pulse Growers
Principal Investigator: Gordon A Zello, PhD University of Saskatchewan
Principal Investigator: Philip Chilibeck, PhD University of Saskatchewan
University of Saskatchewan
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP