A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- University of Jordan
- Enrollment
- 144
- Locations
- 2
- Primary Endpoint
- Blood pressure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The main objective of the study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the efficacy of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, and beans) on the clinical features, biochemical, and hormonal parameters of PCOS compared to the healthy therapeutic lifestyle changes diet.
Detailed Description
The main objective of the study is to identify the effect of pulses on a range of PCOS and metabolic syndrome features. In this parallel clinical trial, 110 (18-35 years old) women with PCOS will be recruited. Participants will be randomly assigned to either a pulse-based diet or a therapeutic lifestyle changes-based diet. The effect of a pulse-based diet on a range of reproductive and metabolic parameters will be evaluated. The results of this study are anticipated to evaluate the therapeutic merits of a pulse-based diet for women with PCOS which would influence dietary guidelines.
Investigators
Shatha Hammad, Assistant Professor
Assistant Professor
University of Jordan
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- •Aged 18-35 years
Exclusion Criteria
- •Individuals that are Keto diet, vegetarian, pregnant, lactating, class 2 obese (body mass index (BMI) ≥35) current smoker, or if they have diabetes, cardiovascular, kidney, liver, or hormonal disease.
- •Individuals taking any medication or supplementation known to affect lipid, glucose, or hormone levels, and/or body weight for at least the last 3 months.
- •Any individual who has an allergy or intolerance to pulses.
Outcomes
Primary Outcomes
Blood pressure
Time Frame: Change from Baseline Systolic Blood Pressure at 3 months
In mmHg.(Systolic and Diastolic)
Blood concentration of androgen hormone
Time Frame: Change from Baseline sample at 3 months
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Ovulatory dysfunction
Time Frame: During nine months
Assessed by measuring the duration of the menstrual cycle
Lipid profile
Time Frame: Change from Baseline sample at 3 months
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Physical activity
Time Frame: Change from Baseline point at 3 months
The validated Arabic short form of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate physical activity of all participants. And an overall total physical activity MET-minutes/week score can be computed as: Total physical activity MET-minutes/week = sum of Total (Walking + Moderate + Vigorous) MET- minutes/week scores. ( \< 4 : Low), (4-6 Moderate) and ( \>6: Vigorous)
Ovarian volume
Time Frame: Change from Baseline ovarian morphology at 3 months
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Change in fat mass
Time Frame: Change from Baseline measurements at 3 months
Body composition scan using InBody 120 (the body composition analyzer) will be evaluated for all participants across the 2 study arms