Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise
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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 |
- 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 ]
- 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 |
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| Contact: Gordon A Zello, PhD | 306 966-5825 | gordon.zello@usask.ca |
| 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 | |
| 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 Metabolic Syndrome X Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013