Clinical trial · Interventional
Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome
- 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)
Currently, there is still insufficient data to support the long-term efficacy, safety, and health benefits of time-restricted feeding models in women diagnosed with Polycystic ovary syndrome (PCOS), and further studies are needed to test and validate the effects of long-term dietary management in PCOS. On the other hand, similarly, studies investigating the effects of the Mediterranean Diet on body composition and dietary intake in women with PCOS are limited. The primary aim of this research is to examine the effect of time-restricted feeding and the Mediterranean diet model on body composition and dietary intake in adult women diagnosed with PCOS. The secondary aim is to evaluate the effect of different dietary models on quality of life in women diagnosed with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intermittent fasting | Other | — | UNRESOLVED |
| Mediterranean diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mediterranean diet group
- description
- Mediterranean diet
- interventionNames
- Other: Mediterranean diet
- type
- ACTIVE_COMPARATOR
- label
- intermittent fasting group
- description
- intermittent fasting
- interventionNames
- Other: intermittent fasting
Primary outcomes (1)
- measure
- Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50)
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Being between 20-49 years of age * Having been diagnosed with PCOS by a specialist according to Rotterdam criteria * Having a BMI between 25-35 kg/m2 * Not having any conditions that impair reality testing and cognitive functions, preventing interviews or completing scales * Being literature * Having signed the informed consent form by agreeing to participate in the study. Exclusion Criteria: * Combination of other endocrine etiological disorders according to Rotterdam criteria (congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, thyroid, adrenal and other endocrine disorders) * Combination of cardiovascular and cerebrovascular diseases, hematological disorders, hepatic and renal failure and other serious diseases * Liver and kidney disease * Use of insulin or oral antidiabetic drugs, * Being pregnant and lactating * Low compliance and non-compliance with treatment during the intervention (individuals with less than 80% compliance will be excluded from the study) * Preparation for pregnancy status during the dietary intervention * Women with pacemakers or defibrillators implanted due to the theoretical possibility of interference with device activity due to the current field caused by impedance measurements * Use of medication affecting carbohydrate or lipid metabolism in the last 6 months (oral contraceptive pills, insulin sensitizers, antiepileptics, antipsychotics, statins and fish oil) * A psychiatric condition diagnosed by a physician It has been determined as a disease state.
References
Publications (1)
- 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