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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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Metabolic Syndrome Other: Pulse-based diet Other: TLC diet Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 2017


Arm Intervention/treatment
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288638


Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N5C9
Sponsors and Collaborators
University of Saskatchewan
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Investigators
Principal Investigator: Gordon A Zello, PhD University of Saskatchewan
Principal Investigator: Philip Chilibeck, PhD University of Saskatchewan

Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01288638     History of Changes
Other Study ID Numbers: Pulse-PCOS
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Phil Chilibeck, University of Saskatchewan:
Polycystic Ovary Syndrome
Metabolic Syndrome
Pulse
Lifestyle Intervention
Aerobic Exercise
Diet

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases