Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
NCT ID: NCT05768724
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-01-01
2022-02-01
Brief Summary
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Detailed Description
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Anthropometric measurements, body composition analysis, and a physical activity questionnaire were performed at the beginning and end of the study, and three-day food consumption records and blood samples for the measurement of biochemical parameters were collected. In addition, the physical activity and food consumption records of the participants were repeated in monthly controls and their anthropometric measurements and body composition were analyzed and compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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İntervention group
METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS
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.
conrol group
American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Age 13-18 years,
* Body mass index (BMI) ≥ 95th percentile
Exclusion Criteria
* Cardiovascular and cerebrovascular diseases,
* Hematologic disorders
* Liver and kidney failure
* Mental disorders
* Eating disorders
* Contraceptive use in the last 3 months
* Use of insulin-sensitizing agents
* Use of drugs affecting lipid metabolism (such as fish oil)
* Smoking.
13 Years
18 Years
FEMALE
Yes
Sponsors
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Gazi University
OTHER
Responsible Party
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Esra Döğer
Principal Investigator
Principal Investigators
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Rukiye BOZBULUT, Dr
Role: STUDY_CHAIR
Gazi Univeristy
Mahmut Orhun Çamurdan, prof
Role: STUDY_CHAIR
Gazi University
Aysun Bideci, prof
Role: STUDY_DIRECTOR
Gazi University
Locations
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Esra Döğer
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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Gazi University Medicine
Identifier Type: -
Identifier Source: org_study_id
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