A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS
- Conditions
- Polycystic Ovary SyndromeMetabolic Syndrome
- Registration Number
- NCT05428566
- Lead Sponsor
- University of Jordan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 144
- Female
- Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- Aged 18-35 years
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood pressure Change from Baseline Systolic Blood Pressure at 3 months In mmHg.(Systolic and Diastolic)
Blood concentration of androgen hormone Change from Baseline sample at 3 months Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Ovulatory dysfunction During nine months Assessed by measuring the duration of the menstrual cycle
Lipid profile Change from Baseline sample at 3 months Blood Cholesterol will be evaluated for all participants across the 2 study arms
Physical activity 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 Change from Baseline ovarian morphology at 3 months An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Change in fat mass 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The University of Jordan
🇯🇴Amman, Jordan
Jordan University Hospital
🇯🇴Amman, Jordan
The University of Jordan🇯🇴Amman, Jordan