Metabolic Syndrome, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Metabolic Syndrome, Therapeutic Lifestyle Changes Diet, Pulse-Based Diet, Aerobic Exercise
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.
Interventions
DIETARY_SUPPLEMENTPulse-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.
DIETARY_SUPPLEMENTTLC 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.
Sponsors
Abdul Hameed Shoman Foundation
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Change from Baseline Systolic Blood Pressure at 3 months | In mmHg.(Systolic and Diastolic) |
| Ovarian volume | Change from Baseline ovarian morphology at 3 months | An experienced ultrasonographer will evaluate the ovarian volume for each ovary. |
| Blood concentration of androgen hormone | Change from Baseline sample at 3 months | Androgen hormone; testosterone will be evaluated for all participants across the 2 study arms |
| Ovulatory dysfunction | During nine months | Assessed by measuring the duration of the menstrual cycle |
| Lipid profile | Change from Baseline sample at 3 months | Blood Cholesterol will be evaluated for all participants across the 2 study arms |
| Change in fat mass | 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 |
| Physical activity | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Previous dietary consumption | 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. |
Countries
Jordan
Outcome results
None listed