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NCT05188430: CHITOCHOL
Metabolic Effect of an Innovative Chitosan Formulation
NA trial testing Medical Device (Kaptufat®) in Hypercholesterolemia in 60 participants. Status unknown.
3 September 2022
Quick facts
| Lead sponsor | University of Bologna |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 March 2022 |
| Primary completion | 3 September 2022 |
| Estimated completion | 3 September 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Medical Device (Kaptufat®)
- Placebo
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
- Overweight and Obesity — all drugs for Overweight and Obesity →
Sponsor
University of Bologna
Who can join
Adults 18 to 70, any sex, with Hypercholesterolemia or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine. In addition to reducing low-density lipoprotein cholesterol (LDL-C) levels, several studies showed that chitosan administration may help reduce body weight. For this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of CVDs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05188430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05188430 (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: 12 January 2022
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/NCT05188430.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing