Metabolic Effect of an Innovative Chitosan Formulation

Hypercholesterolemia Clinical Trial

— CHITOCHOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05188430
• Other study ID #: Chito_RCT2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 3, 2022

Study information

• Verified date: December 2021
• Source: University of Bologna
• Contact: Arrigo F.G. Cicero, MD, PhD
• Phone: +39516362224
• Email: arrigo.cicero[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 3, 2022
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Italy	AOU Policlinico S.Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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