Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06380010 |
Other study ID # |
IASO HOSPITAL (ATHENS-GREECE) |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.