NCT Number: NCT05428566
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.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Jordan University Hospital, Amman, Amman Governorate, Jordan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change from Baseline sample at 3 months
Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms
Time frame: Change from Baseline ovarian morphology at 3 months
An experienced ultrasonographer will evaluate the ovarian volume for each ovary.
Time frame: During nine months
Assessed by measuring the duration of the menstrual cycle
Time frame: Change from Baseline sample at 3 months
Blood Cholesterol will be evaluated for all participants across the 2 study arms
Time frame: 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
Time frame: 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)
Time frame: Change from Baseline Systolic Blood Pressure at 3 months
In mmHg.(Systolic and Diastolic)
Time frame: Baseline point. (At the beginning of the study)
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.
University of Jordan
Other
A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
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