Clinical trial NCT01288638: Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Metabolic Syndrome
Keywords: Polycystic Ovary Syndrome
Metabolic Syndrome
Pulse
Lifestyle Intervention
Aerobic Exercise
Diet
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
name: Saskatchewan Pulse Growers
First posted: 2011-02-02
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Change in polycystic ovary syndrome disease measures from baseline
timeFrame: At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up
Secondary outcomes:
measure: Change in metabolic syndrome disease measures from baseline
timeFrame: At baseline, before TLC lead-in, twice during the intervention, at 6 months follow-up and at 12 months follow-up
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Gordon A Zello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Philip Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.