NCT05428566Completed
A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS
A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women with Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 25 Jul 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- University of Jordan
- NCT number
- NCT05428566
What you commit to
- Study type: Interventional
- Participants enrolled: 144
- From 1 Jan 2022 to the primary completion date, 1 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Any individual who has an allergy or intolerance to pulses.
Lab values
- 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.
Who the study is looking for
- Female
- Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).
- Aged 18-35 years
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Jordan Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
| Jordan University Hospital Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.