Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary Syndrome
- Registration Number
- NCT06380010
- Lead Sponsor
- Iaso Maternity Hospital, Athens, Greece
- Brief Summary
The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial.
- Detailed Description
The aim of the present randomised controlled trial was to investigate the effects of a Mediterranean Diet (MD) intervention delivered through a Clinical Decision Support System (CDSS) on various dietary, health parameters and anxiety in adolescent females, aged 15-17 years, with PCOS. A randomized controlled trial was conducted with 40 adolescent females diagnosed with PCOS, randomly assigned to either an Intervention group (IG) (n=20) or a Control group (CG) (n=20). The IG received personalized dietary guidance based on the MD principles, delivered through a CDSS, while the CG received general nutritional advice. Measurements of dietary intake, anthropometric indices, biochemical markers, and psychological well-being were collected at baseline and after a 3-month intervention period. After 3 months, significant improvements were observed in the IG compared to the CG. Adherence to the MD increased significantly in the IG, leading to decreased caloric intake, fat, saturated fatty acids, and dietary cholesterol, and increased intake of monounsaturated fatty acids. Conversely, the CG experienced an increase in fat and dietary cholesterol intake. Both groups exhibited an increase in fiber intake, with a more pronounced rise observed in the MD group. Psychological well-being showed a significant reduction in anxiety levels in the IG group, while no significant change was observed in the CG. The intervention led to improvements in dietary patterns, body composition, and psychological well-being. These results underscore the importance of dietary interventions tailored to the MD principles in the management of PCOS among adolescent females.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- Newly diagnosed with PCOS females <18 years of age.
- Females with guardians who provided signed participation consent.
- Females ≥18 years of age.
- Females suffering from severe illnesses (i.e., organ failure, autoimmune diseases, congenital metabolic disorders), psychiatric disease or with emerging health issues that could hinder the trial.
- Pregnant or lactating females.
- Females diagnosed with alcoholism or drug addiction.
- Females being under any drug treatment.
- Females followed a specific type of diet within the past 5 years or have used nutrient or non-nutrient supplements within the last 6 months.
- Females with guardians non able to read and understand the consent information.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adherance to the Mediterranean diet 3 months Adherance was assessed with the Kidmed score
- Secondary Outcome Measures
Name Time Method Improvement of psychological well-being 3 months Psychological well-being was assessed by the Hospital Anxiety-Depression Scale (HADS)
Trial Locations
- Locations (1)
IASO Hospital
🇬🇷Athens, Greece
IASO Hospital🇬🇷Athens, Greece