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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.

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
NameTimeMethod
Blood pressureChange from Baseline Systolic Blood Pressure at 3 months

In mmHg.(Systolic and Diastolic)

Blood concentration of androgen hormoneChange from Baseline sample at 3 months

Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms

Ovulatory dysfunctionDuring nine months

Assessed by measuring the duration of the menstrual cycle

Lipid profileChange from Baseline sample at 3 months

Blood Cholesterol will be evaluated for all participants across the 2 study arms

Physical activityChange 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 volumeChange from Baseline ovarian morphology at 3 months

An experienced ultrasonographer will evaluate the ovarian volume for each ovary.

Change in fat massChange 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
NameTimeMethod

Trial Locations

Locations (2)

The University of Jordan

🇯🇴

Amman, Jordan

Jordan University Hospital

🇯🇴

Amman, Jordan

The University of Jordan
🇯🇴Amman, Jordan

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