Clinical trial · Observational
The Results of the Mediterranean Diet for PCOS
Prospective Evaluation of the Effects of the Mediterranean Diet on the Reproductive and Metabolic Parameters of Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) and a Body Mass Indexof Over 25 kg/m2
NCT06442189CI-TRIAL-00082729PCOScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diet Habit | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean Diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 3. month
- description
- Once the baseline values have been determined at the first visit, all tests are repeated after the diet has been followed for 3 months.
- interventionNames
- Dietary Supplement: Mediterranean Diet
Primary outcomes (4)
- measure
- the effect of applying a Mediterranean diet on Homa-IR in PCOS
- timeFrame
- 3 months
- description
- Homeostasis model assessment (HoMA)-IR
- measure
- PREDIMED in PCOS
- timeFrame
- 3 months
- description
- PREDIMED questionnaire
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * At the age of 18-40 years, * No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia), * With a body mass index of 25 and above, * Female patients attending the PCOS clinic and under the care of our hospital's dietitian will be enrolled in the study. Exclusion Criteria: 1. Age \< 18 and \> 40 years; 2. Menopause, pregnancy or breastfeeding in the last 6 months; 3. Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders), 4. Pre-existing systemic or psychiatric disease 5. Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil); 6. Certain eating regimens or hypocaloric diet in the last three months; supplementing with antioxidants, vitamins or minerals; 7. Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that may affect fluid balance 8. Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity.
References
Publications (2)
- RESULTLegro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393. PMID 9920077
- RESULTBarrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278. PMID 31547562