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NCT06308757: KETONASH
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
NA trial testing Very-low-calorie ketogenic diet (VLCKD) with meal replacements in NASH in 42 participants. Currently enrolling.
24 November 2024
Quick facts
| Lead sponsor | University of Bologna |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 29 September 2021 |
| Primary completion | 24 November 2024 |
| Estimated completion | 12 December 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Very-low-calorie ketogenic diet (VLCKD) with meal replacements
- Mediterranean low-calorie diet (LCD)
Conditions studied
- NASH — all drugs for NASH →
- NAFLD — all drugs for NAFLD →
- Obesity — all drugs for Obesity →
- Liver Fibrosis — all drugs for Liver Fibrosis →
Sponsor
University of Bologna
Who can join
18 and older, any sex, with NASH or NAFLD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06308757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Bologna trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06308757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bologna
- Last refreshed: 15 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06308757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing