Metabolic Effect of an Innovative Chitosan Formulation (CHITOCHOL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercholesterolemia; Overweight and Obesity
• Intervention / Treatment: Device: Medical Device (Kaptufat®); Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arrigo F.G. Cicero, MD, PhD; Phone Number: +39516362224; Email: arrigo.cicero@unibo.it

Study Locations

• Italy
  • Bologna, Italy
    • AOU Policlinico S.Orsola-Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Oral administration: 3 tablets twice a day before the main meals
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in LDL-C from baseline and between groups	Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in LDL-C from baseline and between groups	Absolute change in LDL-C from baseline and between groups after 6 weeks of treatment with MD compared to placebo	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	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	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	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	6 weeks
Absolute change in lipids ratios from baseline and between groups	Absolute change in lipids ratios from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in lipid accumulation product (LAP) from baseline and between groups	Absolute change in LAP from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in lipids ratios from baseline and between groups	Absolute change in lipids ratios from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in LAP from baseline and between groups	Absolute change in LAP from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in fasting plasma glucose (FPG) from baseline and between groups	Absolute change in FPG from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in fasting plasma insulin from baseline and between groups	Absolute change in fasting plasma insulin from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in fasting plasma glucose (FPG) from baseline and between groups	Absolute change in FPG from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in fasting insulin from baseline and between groups	Absolute change in fasting insulin from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups	Absolute change in HOMA-IR index from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in HOMA-IR index from baseline and between groups	Absolute change in HOMA-IR index from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in weight from baseline and between groups	Absolute change in weight from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in weight from baseline and between groups	Absolute change in weight from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in waist circumference from baseline and between groups	Absolute change in waist circumference from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in waist circumference from baseline and between groups	Absolute change in waist circumference from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in body mass index (BMI) from baseline and between groups	Absolute change in BMI from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in body mass index (BMI) from baseline and between groups	Absolute change in BMI from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups	Absolute change in VAI from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in index of central obesity (ICO) from baseline and between groups	Absolute change in ICO from baseline and between groups after 6 weeks of treatment with MD compared to placebo	6 weeks
Absolute change in index of central obesity (ICO) from baseline and between groups	Absolute change in ICO from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups	Absolute change in VAI from baseline and between groups after 12 weeks of treatment with MD compared to placebo	12 weeks

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Arrigo F.G. Cicero, MD, PhD, AOU Policlinico S. Orsola-Malpighi

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): September 3, 2022
• Study Completion (ANTICIPATED): September 3, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (ACTUAL): January 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Overweight; Hypercholesterolemia; Lipids; Medical device; Chitosan; Low-density lipoprotein cholesterol; Class I obesity
• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Overweight; Hypercholesterolemia
• Other Study ID Numbers: Chito_RCT2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No