Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380010
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Brief Title:
Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome
Sponsor:
Iaso Maternity Hospital Athens Greece
Organization:
Iaso Maternity Hospital Athens Greece
Study Overview
Official Title:
Optimizing Dietary Habits in Adolescents With Polycystic Ovary Syndrome Personalized Mediterranean Diet Intervention Via Clinical Decision Support System A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n20 or a Control group receiving general nutritional advice n20 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 n20 or a Control group CG n20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None