Clinical trial · Interventional
Effects of a Ketogenic Diet on PCOS Outcomes
Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
NCT04163120CI-TRIAL-00041638completedN/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)
The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- In this single arm study subjects follow a low calorie mediterranean ketogenci diet
- interventionNames
- Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)
Primary outcomes (13)
- measure
- Body Weight
- timeFrame
- 12 weeks
- description
- Body weight will be measured by an electronic scale
- measure
- Fat body mass
- timeFrame
- 12 weeks
- description
- will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between * oligo/anovulation * hyperandrogenism * clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria * fertile age (18-45 years); * BMI\> 25 kg/m2, * desire to lose weight; * acceptance not to use contraceptives during the experimental period Exclusion Criteria: * pregnancy and lactation, * hormonal therapy and/or insulin-sensitizers in the last 2 months, * hepatic, renal and heart diseases
References
Publications (7)
- BACKGROUNDPaoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A. Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11. PMID 22327146
- BACKGROUNDPaoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26. PMID 23801097
- BACKGROUNDPaoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534. PMID 31311141
- 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
- BACKGROUNDGalletly C, Moran L, Noakes M, Clifton P, Tomlinson L, Norman R. Psychological benefits of a high-protein, low-carbohydrate diet in obese women with polycystic ovary syndrome--a pilot study. Appetite. 2007 Nov;49(3):590-3. doi: 10.1016/j.appet.2007.03.222. Epub 2007 Apr 4. PMID 17509728
- DERIVEDMoro T, Monaco L, Naro F, Reggiani C, Paoli A. Exercise Intensity and Rest Intervals Effects on Intracellular Signals and Anabolic Response of Skeletal Muscle to Resistance Training. J Strength Cond Res. 2024 Oct 1;38(10):1695-1703. doi: 10.1519/JSC.0000000000004209. Epub 2022 Jan 5. PMID 40168063
- DERIVEDPaoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020 Feb 27;18(1):104. doi: 10.1186/s12967-020-02277-0. PMID 32103756