CHITOCHOL: Metabolic Effect of an Innovative Chitosan Formulation

Sponsor

University of Bologna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05188430

Collaborator

(none)

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Overweight and Obesity	Device: Medical Device (Kaptufat®) Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 3, 2022

Anticipated Study Completion Date :

Sep 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active treatment Medical Device (Kaptufat®)	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
Placebo Comparator: Placebo Placebo	Other: Placebo Oral administration: 3 tablets twice a day before the main meals

Arm

Intervention/Treatment

Active Comparator: Active treatment

Medical Device (Kaptufat®)

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

Placebo Comparator: Placebo

Placebo

Other: Placebo

Oral administration: 3 tablets twice a day before the main meals

Outcome Measures

Primary Outcome Measures

Absolute change in LDL-C from baseline and between groups [12 weeks]
Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo

Secondary Outcome Measures

Absolute change in LDL-C from baseline and between groups [6 weeks]
Absolute change in LDL-C from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups [12 weeks]
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups [6 weeks]
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in lipids ratios from baseline and between groups [6 weeks]
Absolute change in lipids ratios from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in lipid accumulation product (LAP) from baseline and between groups [6 weeks]
Absolute change in LAP from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in lipids ratios from baseline and between groups [12 weeks]
Absolute change in lipids ratios from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in LAP from baseline and between groups [12 weeks]
Absolute change in LAP from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in fasting plasma glucose (FPG) from baseline and between groups [12 weeks]
Absolute change in FPG from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in fasting plasma insulin from baseline and between groups [12 weeks]
Absolute change in fasting plasma insulin from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in fasting plasma glucose (FPG) from baseline and between groups [6 weeks]
Absolute change in FPG from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in fasting insulin from baseline and between groups [6 weeks]
Absolute change in fasting insulin from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups [6 weeks]
Absolute change in HOMA-IR index from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in HOMA-IR index from baseline and between groups [12 weeks]
Absolute change in HOMA-IR index from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in weight from baseline and between groups [12 weeks]
Absolute change in weight from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in weight from baseline and between groups [6 weeks]
Absolute change in weight from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in waist circumference from baseline and between groups [6 weeks]
Absolute change in waist circumference from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in waist circumference from baseline and between groups [12 weeks]
Absolute change in waist circumference from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in body mass index (BMI) from baseline and between groups [12 weeks]
Absolute change in BMI from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in body mass index (BMI) from baseline and between groups [6 weeks]
Absolute change in BMI from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups [6 weeks]
Absolute change in VAI from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in index of central obesity (ICO) from baseline and between groups [6 weeks]
Absolute change in ICO from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Absolute change in index of central obesity (ICO) from baseline and between groups [12 weeks]
Absolute change in ICO from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups [12 weeks]
Absolute change in VAI from baseline and between groups after 12 weeks of treatment with MD compared to placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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