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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Saskatchewan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01288638
First received: January 13, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Polycystic Ovary Syndrome
Metabolic Syndrome
Other: Pulse-based diet
Other: TLC diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288638

Contacts
Contact: Gordon A Zello, PhD 306 966-5825 gordon.zello@usask.ca

Locations
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N5C9
Contact: Gordon A Zello, PhD    (306) 966-5825    gordon.zello@usask.ca   
Contact: Philip D Chilibeck, PhD    (306) 966-1072    phil.chilibeck@usask.ca   
Principal Investigator: Gordon A Zello, PhD         
Principal Investigator: Philip Chilibeck, PhD         
Sub-Investigator: Donna Chizen, MD, FRCSC         
Sub-Investigator: Karen Lawson, PhD         
Sub-Investigator: Roger Pierson, PhD         
Sub-Investigator: Carol Rodgers, PhD         
Sub-Investigator: Lauren Sherar, PhD         
Sub-Investigator: Kavitha Ramachandran, MSc         
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
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01288638     History of Changes
Other Study ID Numbers: Pulse-PCOS
Study First Received: January 13, 2011
Last Updated: July 31, 2012
Health Authority: Canada: University of Saskatchewan Biomedical Research Ethics Board

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Metabolic Syndrome X
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

ClinicalTrials.gov processed this record on September 18, 2014