MedDataX Logo

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

NCT ID: NCT01288638

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Metabolic Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Polycystic Ovary Syndrome Metabolic Syndrome Pulse Lifestyle Intervention Aerobic Exercise Diet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pulse-based diet

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

TLC diet

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

Saskatchewan Pulse Growers

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Phil Chilibeck

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gordon A Zello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Philip Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32153805 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32092167 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31558086 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30274344 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pulse-PCOS

Identifier Type: -

Identifier Source: org_study_id