Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
NCT05768724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-03-14
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
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