Metabolic Effect of an Innovative Chitosan Formulation (CHITOCHOL)

University of Bologna

Status: Unknown

Conditions: Hypercholesterolemia; Overweight and Obesity

Treatments: Device: Medical Device (Kaptufat®); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05188430

Chito_RCT2022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects agree to participate in the study and having dated and signed the informed consent form;
• Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
• Male or female aged ≥ 18 years and ≤ 70 years old;
• Subjects free from cardiovascular diseases (CVDs) (primary prevention for CVDs);
• Subjects with sub-optimal serum levels of cholesterol (total cholesterol (TC) of 200-240 mg/dl OR LDL-C of 130-190 mg/dl);
• Subjects with body mass index (BMI) 25 -34.9 Kg/m2

Exclusion criteria

• Subjects already affected by CVDs (secondary prevention for CVDs);
• Subjects with serum levels of triglycerides (TG)> 400 mg/dl;
• Type 1 or type 2 diabetes;
• Lipid-lowering treatment not stabilized since at least 2 months;
• Known current gastrointestinal diseases and use of medications for their treatment;
• Known clinically relevant decline in renal function;
• Women in fertile age not using consolidated contraceptive methods
• Pregnancy and Breastfeeding;
• History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
• Any medical or surgical condition that would limit the patient adhesion to the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Active treatment

Active Comparator group

Description:

Medical Device (Kaptufat®)

Treatment:

Device: Medical Device (Kaptufat®)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo