Clinical trial · Interventional
Combination of D-chiro-inositol With Ketogenic Diet
Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of Overweight/Obese Patients With Insulin Resistance and Polycystic Ovary Syndrome
NCT05348967CI-TRIAL-00090539withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No partecipants enrolled
Summary
Brief summary (as posted)
The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone
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 |
|---|---|---|---|
| TECADRIOL | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Ketogenic diet
- type
- EXPERIMENTAL
- label
- TECADRIOL
- description
- Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
- interventionNames
- Dietary Supplement: TECADRIOL
Primary outcomes (1)
- measure
- HOMA index
- timeFrame
- Three time points: change in HOMA index from the baseline to 2 and 4 months
- description
- Reduction of HOMA index
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Women with age between 25 and 40 years * Diagnosis of Polycystic Ovary Syndrome (PCOS) * Diagnosis of insulin-resistance (HOMA ≥2.5) * 26 ≤ BMI ≤32 Exclusion Criteria: * Subjects with no indication for treatment * Pregnancy, breastfeeding * Treatment with drugs or supplements that interfere with the mechanism of action of insulin
References
Publications (0)
Data not yet available
No reference posted for this study.