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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428566
• Other study ID #: 2020-2019/27
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: University of Jordan
• Contact: Shatha Hammad, PhD
• Phone: +96265355000
• Email: sh.hammad[@]ju.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Pulse-based diet
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.
• TLC diet
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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman
Jordan	The University of Jordan	Amman

Sponsors (2)

Lead Sponsor	Collaborator
University of Jordan	Abdul Hameed Shoman Foundation

Country where clinical trial is conducted

Jordan, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Previous dietary consumption	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.	Baseline point. (At the beginning of the study)
Primary	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
Primary	Ovarian volume	An experienced ultrasonographer will evaluate the ovarian volume for each ovary.	Change from Baseline ovarian morphology at 3 months
Primary	Ovulatory dysfunction	Assessed by measuring the duration of the menstrual cycle	During nine months
Primary	Lipid profile	Blood Cholesterol will be evaluated for all participants across the 2 study arms	Change from Baseline sample at 3 months
Primary	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
Primary	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
Primary	Blood pressure	In mmHg.(Systolic and Diastolic)	Change from Baseline Systolic Blood Pressure at 3 months

External 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