Clinical trial · Interventional
Low-Carb Versus Mediterranean Diet in PCOS
Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.
NCT05272657CI-TRIAL-00057496unknownN/AClinicalTrials.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)
This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.
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 (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-carbohydrate diet | Other | — | UNRESOLVED |
| Mediterranean diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- low-carbohydrate diet
- description
- subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
- interventionNames
- Other: low-carbohydrate diet
- type
- EXPERIMENTAL
- label
- Mediterranean diet
- description
- subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
- interventionNames
- Other: Mediterranean diet
Primary outcomes (2)
- measure
- 1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45. * Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group): * signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone) * signs of chronic anovulation * ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche. Exclusion Criteria: * The presence of hyperprolactinemia * Cushing's syndrome * Ongenital hyperplasia of the adrenal cortex * Hypothyroidism * Androgen-producing tumors * Regular use of drugs and dietary supplements that affect the function of the ovaries * Adrenal glands * Metabolism of carbohydrates * Lipids * Microbiota composition during the 2 months preceding the study * Pregnancy * Lactation * Significant comorbidities
References
Publications (0)
Data not yet available
No reference posted for this study.