NCT05188430

Metabolic Effect of an Innovative Chitosan Formulation

A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hypercholesterolemia
• Overweight and Obesity

Interventions

Type	Name	Description
DEVICE	Medical Device (Kaptufat®)	140 mg chitosan, 460 mg cellulose and 35.384 mg ascorbic acid for 1 tablet Oral administration: 3 tablets twice a day before the main meals
OTHER	Placebo	Oral administration: 3 tablets twice a day before the main meals

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-09-03
• Completion: 2022-09-03
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: Italy