Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

NCT05768724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-14

No results posted yet for this study

Summary

This study was conducted to evaluate the efficacy of the MEtabolic Syndrome REduction in NAvarra (RESMENA) diet versus a control diet based on American Heart Association (AHA) recommendations for the treatment of PCOS in adolescents with obesity and PCOS. A total of 40 adolescents diagnosed with PCOS between the ages of 13-18 years were randomized to either a Resmena or control diet for 6 months. Dietary status, anthropometry, body composition, biochemical parameters, and reproductive endocrine hormones were compared between the 2 groups before and after the intervention.

Conditions

  • Polycystic Ovary Syndrome
  • Obesity
  • Androgen; Hypersecretion
  • Diet, Healthy

Interventions

BEHAVIORAL

intervention diet

The Resmena diet: It was characterized by a higher meal frequency, consisting of seven meals/d (including breakfast, lunch, dinner, and two snacks in the morning and two snacks in the afternoon), and by a different macronutrient distribution; 40% total energy value from CHO, 30% from proteins and 30% from lipids. This pattern tried to reinforce high n-3 polyunsaturated FA (n-3 PUFA) and high natural antioxidant food consumption and promoted low GL CHO intake as well as a high adherence to the Mediterranean diet. It also maintained a healthy FA profile and a cholesterol content of less than 300 mg/day. * Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked.

BEHAVIORAL

control diet

Control diet: It was based on the American Heart Association (AHA) guidelines, including 3-5 meals per day, a macronutrient distribution of 55% total energy value from carbohydrates, 15% proteins, and 30% lipids, a healthy fatty acids (FA) profile and a cholesterol consumption lower than 300 mg/day. \- Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Rukiye BOZBULUT, Dr · Gazi Univeristy

  • Mahmut Orhun Çamurdan, prof · Gazi University

  • Aysun Bideci, prof · Gazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-05
Completion
2022-02-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768724 on ClinicalTrials.gov