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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
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.
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.
The University of Jordan
Amman, Amman Governorate, Jordan
Jordan University Hospital
Amman, Amman Governorate, Jordan
Blood concentration of androgen hormone
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Time frame: Change from Baseline sample at 3 months
Ovarian volume
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Time frame: Change from Baseline ovarian morphology at 3 months
Ovulatory dysfunction
Assessed by measuring the duration of the menstrual cycle
Time frame: During nine months
Lipid profile
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Time frame: 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
Time frame: 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)
Time frame: Change from Baseline point at 3 months
Blood pressure
In mmHg.(Systolic and Diastolic)
Time frame: Change from Baseline Systolic Blood Pressure at 3 months
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