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

NCT05428566 | Completed

• 1 other identifier: 2020-2019/27
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Keywords

Polycystic Ovary Syndrome; Metabolic Syndrome; Therapeutic Lifestyle Changes Diet; Pulse-Based Diet; Aerobic Exercise

Outcome Measures

Primary Outcomes (7)

• Blood concentration of androgen hormone

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

  Change from Baseline sample at 3 months

• Ovarian volume

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

  Change from Baseline ovarian morphology at 3 months

• Ovulatory dysfunction

  Assessed by measuring the duration of the menstrual cycle

  During nine months

• Lipid profile

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

  Change from Baseline sample at 3 months

• Change in fat mass

  Body composition scan using InBody 120 (the body composition analyzer) will be evaluated for all participants across the 2 study arms

  Change from Baseline measurements at 3 months

• Physical activity

  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)

  Change from Baseline point at 3 months

• Blood pressure

  In mmHg.(Systolic and Diastolic)

  Change from Baseline Systolic Blood Pressure at 3 months

Other Outcomes (1)

• Previous dietary consumption

  Baseline point. (At the beginning of the study)

Study Arms (2)

Pulse-based diet

EXPERIMENTAL

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.

Dietary Supplement: Pulse-based diet

TLC diet

PLACEBO COMPARATOR

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.

Dietary Supplement: TLC diet

Interventions

Pulse-based diet DIETARY_SUPPLEMENT

An isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. 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.

Pulse-based diet

TLC diet DIETARY_SUPPLEMENT

An isocaloric, balanced diet with a fixed macronutrient composition of 28% fat, 55% carbohydrate, and 17% protein. 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.

TLC diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
• Aged 18-35 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead
• Abdul Hameed Shoman Foundation: collaborator

Study Sites (2)

The University of Jordan

Amman, Amman Governorate, 11942, Jordan

Location

Jordan University Hospital

Amman, Amman Governorate, Jordan

Location

Related Publications (35)

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Related Links

• Campos-Vega R, Loarca-Piña G, Oomah BD. Minor components of pulses and their potential impact on human health. Food Research International. 2010;43:461-482

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shatha Hammad, PhD

  The University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: June 23, 2022
• Study Start: January 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)