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NCT Number: NCT06380010

Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

15 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IASO Hospital

Athens, 15123, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed with PCOS females <18 years of age.
  • Females with guardians who provided signed participation consent.

Exclusion criteria

  • 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.

Treatment and study plan

Mediterranean diet group

Other

Females who met the inclusion and exclusion criteria were allocated in groups of one to either the Control group or the Intervention (MD) group using a random assignment method applied by an independent statistician. During the trial, every participant in both groups had two individual sessions with the assigned researchers. These sessions took place at the beginning of the trial and three months later, and involved anthropometry measurements, evaluation of dietary habits, assessment of psychological well-being, and collection of blood samples. Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes.

Primary outcomes

  1. Adherance to the Mediterranean diet

    Time frame: 3 months

    Adherance was assessed with the Kidmed score

Secondary outcomes

  1. Improvement of psychological well-being

    Time frame: 3 months

    Psychological well-being was assessed by the Hospital Anxiety-Depression Scale (HADS)

Sponsors and collaborators

Lead sponsor

Iaso Maternity Hospital, Athens, Greece

Other

Collaborators

  • Harokopio University
  • University of Peloponnese

Registry information

Official study title

Optimizing Dietary Habits in Adolescents With Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention Via Clinical Decision Support System. A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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