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
• Interventions: Dietary Supplement: TLC diet; Dietary Supplement: Pulse-based diet

• 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

Arm && Interventions

Group	Intervention	Description
TLC diet	TLC diet	TLC group will be provided with instructions to follow the TLC guidelines and a sample diet plan will be individualized for each participant. The healthy TLC diet will be tailored for each participant according to their energy levels in order to achieve the following amount of nutrients: less than 7% of total calories of saturated fatty acids, up to 10% of total calories of polyunsaturated fat, up to 20% of total calories of monounsaturated fat, less than 200 mg a day of cholesterol, at least 5 to 10 grams a day of soluble fiber. The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein.
Pulse-based diet	Pulse-based diet	The pulse diet will include two pulse-based meals; each pulse meal will be consisted of about one cup of non-oil seed pulses, different varieties of pulses (dried beans, peas, lentils, lupine, and chickpeas) will be used. Varieties of pulses will be included and the participants will be provided with recipes and preparation ideas, which would enhance the palatability of pulses, give different taste choices, and ease the follow of the prescribed diet and encourage the participants to consume it for the target duration. The diet is isocaloric and balanced with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein.

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