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NCT05188430: CHITOCHOL

Metabolic Effect of an Innovative Chitosan Formulation

Status unknown NA Last updated 12 January 2022
What this trial tests

NA trial testing Medical Device (Kaptufat®) in Hypercholesterolemia in 60 participants. Status unknown.

Timeline
1 March 2022
Primary endpoint
3 September 2022
3 September 2022

Quick facts

Lead sponsorUniversity of Bologna
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date1 March 2022
Primary completion3 September 2022
Estimated completion3 September 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Hypercholesterolemia

Currently open trials in the same condition.

Other University of Bologna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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