Clinical trial · Interventional
Role of the Ketogenic Diet in Women With PCOS
NCT04175964CI-TRIAL-00061223unknownN/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)
For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caloric diet | Behavioral | — | UNRESOLVED |
| caloric diet with Metformin | Combination Product | — | UNRESOLVED |
| ketogenic diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- PCO patients that will receive ketogenic diet only
- interventionNames
- Behavioral: ketogenic diet
- type
- EXPERIMENTAL
- label
- Group 2
- description
- PCO patients that will receive caloric diet with Metformin
- interventionNames
- Combination Product: caloric diet with Metformin
- type
- EXPERIMENTAL
- label
- Group 3
- description
- PCO patients that will receive caloric diet only
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age range between 16-35 years. 2. BMI ≥ 27. 3. Normal Renal Function. 4. Rotterdam criteria for the diagnosis of polycystic ovary syndrome: * Oligo/anovulation * Hyperandrogenism * Polycystic ovaries on ultrasound. Exclusion Criteria: 1. Age \<16 or \>35 years. 2. BMI \< 27. 3. Pregnancy. 4. Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia 5. Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.
References
Publications (3)
- BACKGROUNDMavropoulos JC, Yancy WS, Hepburn J, Westman EC. The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Nutr Metab (Lond). 2005 Dec 16;2:35. doi: 10.1186/1743-7075-2-35. PMID 16359551
- BACKGROUNDPalomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23. PMID 18158291
- BACKGROUNDMoran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9. doi: 10.1210/jc.2002-020815. PMID 12574218