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

NCT01288638 | Completed DMC

• 1 other identifier: Pulse-PCOS
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Keywords

Polycystic Ovary Syndrome; Metabolic Syndrome; Pulse; Lifestyle Intervention; Aerobic Exercise; Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Pulse-based diet

EXPERIMENTAL

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

TLC diet

PLACEBO COMPARATOR

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

Interventions

Pulse-based diet OTHER

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.

Pulse-based diet

TLC diet OTHER

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.

TLC diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Diagnosis of PCOS
• Aged 18-35 years

You may not qualify if:

• Taking birth control or fertility medications
• Medical conditions that limit exercise or which limit consumption of a pulse-based diet (allergies or intolerances)

Sponsors & Collaborators

• University of Saskatchewan: lead
• Agriculture and Agri-Food Canada: collaborator
• Saskatchewan Pulse Growers: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5C9, Canada

Location

Related Publications (4)

• McBreairty LE, Chilibeck PD, Chizen DR, Pierson RA, Tumback L, Sherar LB, Zello GA. The role of a pulse-based diet on infertility measures and metabolic syndrome risk: protocol of a randomized clinical trial in women with polycystic ovary syndrome. BMC Nutr. 2017 Mar 7;3:23. doi: 10.1186/s40795-017-0142-6. eCollection 2017.

  PMID: 32153805 DERIVED

• Kazemi M, Pierson RA, McBreairty LE, Chilibeck PD, Zello GA, Chizen DR. A randomized controlled trial of a lifestyle intervention with longitudinal follow-up on ovarian dysmorphology in women with polycystic ovary syndrome. Clin Endocrinol (Oxf). 2020 Jun;92(6):525-535. doi: 10.1111/cen.14179. Epub 2020 Mar 16.

  PMID: 32092167 DERIVED

• Kazemi M, McBreairty LE, Zello GA, Pierson RA, Gordon JJ, Serrao SB, Chilibeck PD, Chizen DR. A pulse-based diet and the Therapeutic Lifestyle Changes diet in combination with health counseling and exercise improve health-related quality of life in women with polycystic ovary syndrome: secondary analysis of a randomized controlled trial. J Psychosom Obstet Gynaecol. 2020 Jun;41(2):144-153. doi: 10.1080/0167482X.2019.1666820. Epub 2019 Sep 27.

  PMID: 31558086 DERIVED

• Kazemi M, McBreairty LE, Chizen DR, Pierson RA, Chilibeck PD, Zello GA. A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet in Combination with Exercise and Health Counselling on the Cardio-Metabolic Risk Profile in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial. Nutrients. 2018 Sep 30;10(10):1387. doi: 10.3390/nu10101387.

  PMID: 30274344 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gordon A Zello, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Philip Chilibeck, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

CA (1)