A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Metabolic 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.

Study Timeline

• Study First Submitted: 2021-07-25
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-23
• Primary Completion: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Study Completion: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• Female
• 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.

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

Trial Locations

Locations (2)

The University of Jordan; 🇯🇴 Amman, Jordan

Jordan University Hospital; 🇯🇴 Amman, Jordan