Clinical trial NCT05428566: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Metabolic Syndrome
Keywords: Polycystic Ovary Syndrome
Metabolic Syndrome
Therapeutic Lifestyle Changes Diet
Pulse-Based Diet
Aerobic Exercise
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Abdul Hameed Shoman Foundation
First posted: 2022-06-23
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Blood concentration of androgen hormone
timeFrame: Change from Baseline sample at 3 months
measure: Ovarian volume
timeFrame: Change from Baseline ovarian morphology at 3 months
measure: Ovulatory dysfunction
timeFrame: During nine months
measure: Lipid profile
timeFrame: Change from Baseline sample at 3 months
measure: Change in fat mass
timeFrame: Change from Baseline measurements at 3 months
measure: Physical activity
timeFrame: Change from Baseline point at 3 months
measure: Blood pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 3 months
Secondary outcomes:
Other outcomes:
measure: Previous dietary consumption
timeFrame: Baseline point. (At the beginning of the study)
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: The University of Jordan
name: Shatha Hammad, PhD
role: PRINCIPAL_INVESTIGATOR
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