A Comparison of a PULSE Diet and the TLC Diet on Reproductive, Metabolic Parameters in Women with PCOS

Last updated: October 29, 2024
Sponsor: University of Jordan
Overall Status: Completed

Phase

N/A

Condition

Reproductive Health

Diabetes Prevention

Metabolic Syndrome

Treatment

TLC diet

Pulse-based diet

Clinical Study ID

NCT05428566
2020-2019/27
  • Ages 18-35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Diagnosis of PCOS in addition to insulin resistance (Homeostasis model assessment (HOMA)-insulin resistance index ≥ 2).

  • Aged 18-35 years

Exclusion

Exclusion Criteria:

  • Individuals that are Keto diet, vegetarian, pregnant, lactating, class 2 obese (bodymass 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.

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: TLC diet
Phase:
Study Start date:
January 01, 2022
Estimated Completion Date:
October 30, 2024

Study 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.

Connect with a study center

  • Jordan University Hospital

    Amman,
    Jordan

    Site Not Available

  • The University of Jordan

    Amman, 11942
    Jordan

    Site Not Available

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