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

Primary Purpose

Polycystic Ovary Syndrome, Metabolic Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Jordan

Study Type

Interventional

Intervention

Pulse-based diet

TLC diet

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Metabolic Syndrome, Therapeutic Lifestyle Changes Diet, Pulse-Based Diet, Aerobic Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

The University of Jordan
Jordan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pulse-based diet

TLC diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood concentration of androgen hormone

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

Ovarian volume

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

Ovulatory dysfunction

Assessed by measuring the duration of the menstrual cycle

Lipid profile

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

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

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)

Blood pressure

In mmHg.(Systolic and Diastolic)

Secondary Outcome Measures

Full Information

NCT ID

NCT05428566

First Posted

July 25, 2021

Last Updated

August 27, 2023

Sponsor

University of Jordan

Collaborators

Abdul Hameed Shoman Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05428566

Brief Title

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

Official Title

A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women With Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jordan

Collaborators

Abdul Hameed Shoman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Metabolic Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulse-based diet

Arm Type

Experimental

Arm Description

Arm Title

TLC diet

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Pulse-based diet

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

TLC diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Blood concentration of androgen hormone

Description

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

Time Frame

Change from Baseline sample at 3 months

Title

Ovarian volume

Description

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

Time Frame

Change from Baseline ovarian morphology at 3 months

Title

Ovulatory dysfunction

Description

Assessed by measuring the duration of the menstrual cycle

Time Frame

During nine months

Title

Lipid profile

Description

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

Time Frame

Change from Baseline sample at 3 months

Title

Change in fat mass

Description

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

Time Frame

Change from Baseline measurements at 3 months

Title

Physical activity

Description

Time Frame

Change from Baseline point at 3 months

Title

Blood pressure

Description

In mmHg.(Systolic and Diastolic)

Time Frame

Change from Baseline Systolic Blood Pressure at 3 months

Other Pre-specified Outcome Measures:

Title

Previous dietary consumption

Description

A validated Arabic food frequency questionnaire will be completed by all participants to evaluate previous dietary consumption of these women and compare it with dietary recommendations.

Time Frame

Baseline point. (At the beginning of the study)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shatha Hammad, PhD

Phone

+96265355000

sh.hammad@ju.edu.jo

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shatha Hammad, PhD

Organizational Affiliation

The University of Jordan

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Jordan

City

Amman

ZIP/Postal Code

11942

Country

Jordan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shatha Hammad, PhD

Phone

+96265355000

sh.hammad@ju.edu.jo

First Name & Middle Initial & Last Name & Degree

Shatha Hammad, PhD

Facility Name

Jordan University Hospital

City

Amman

Country

Jordan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shatha Abu-AlNadi

pulse.tlcresearch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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

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