Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06380010
• Other study ID #: IASO HOSPITAL (ATHENS-GREECE)
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2024
• Source: Iaso Maternity Hospital, Athens, Greece
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Newly diagnosed with PCOS females <18 years of age.

2. Females with guardians who provided signed participation consent.

Exclusion Criteria:

1. Females =18 years of age.

2. 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.

3. Pregnant or lactating females.

4. Females diagnosed with alcoholism or drug addiction.

5. Females being under any drug treatment.

6. 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.

7. Females with guardians non able to read and understand the consent information.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Mediterranean diet group
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.

Locations

Country	Name	City	State
Greece	IASO Hospital	Athens

Sponsors (3)

Lead Sponsor	Collaborator
Iaso Maternity Hospital, Athens, Greece	Harokopio University, University of Peloponnese

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherance to the Mediterranean diet	Adherance was assessed with the Kidmed score	3 months
Secondary	Improvement of psychological well-being	Psychological well-being was assessed by the Hospital Anxiety-Depression Scale (HADS)	3 months