Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Obesity; Androgen; Hypersecretion; Diet, Healthy
MeSH terms: Polycystic Ovary Syndrome; Obesity; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      The purpose of this study was to investigate the effect of a high meal frequency, low
      carbohydrate, high protein, high n-3 PUFA, healthy fatty acid and antioxidant content, low
      glycemic load Resmena diet or a control diet based on AHA recommendations on anthropometric
      measurements, body composition, insulin resistance, lipid metabolism levels, inflammatory
      markers and reproductive endocrine levels in adolescents with obesity and PCOS..Randomized
      controlled study design was used in the study. Patients in the study were allocated to the
      control and study intervention groups. Participants were invited to face-to-face interviews
      at the beginning of the study and monthly for 6 months.

      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.
    

Intervention name(s): intervention diet; control diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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: 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blind, randomized, two-arm, parallel six-month dietary intervention.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment