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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
Completed |
NCT06158932 -
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04932070 -
Berberine and Polycystic Ovary Syndrome
|
N/A | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT03480022 -
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
|
Phase 3 | |
Active, not recruiting |
NCT03043924 -
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
|
N/A | |
Completed |
NCT05246306 -
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
|
||
Completed |
NCT05981742 -
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
|
Phase 2 | |
Completed |
NCT05702957 -
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT05029492 -
Effect of Visceral Manipulation on PCOS
|
N/A | |
Completed |
NCT02924025 -
Motivational Interviewing as an Intervention for PCOS
|
N/A | |
Not yet recruiting |
NCT02255578 -
Endobarrier Treatment in Women With PCOS
|
Phase 3 | |
Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
Withdrawn |
NCT01638988 -
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
|
Phase 3 | |
Completed |
NCT02098668 -
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
|
N/A | |
Completed |
NCT01462864 -
Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome
|
N/A | |
Recruiting |
NCT01431352 -
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
|
N/A | |
Completed |
NCT00989781 -
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
|
N/A |