Clinical trial NCT05188430: Metabolic Effect of an Innovative Chitosan Formulation
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Overweight and Obesity
Keywords: Hypercholesterolemia
Overweight
Class I obesity
Low-density lipoprotein cholesterol
Lipids
Chitosan
Medical device
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in LDL-C from baseline and between groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Absolute change in LDL-C from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in lipids ratios from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in lipid accumulation product (LAP) from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in lipids ratios from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in LAP from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in fasting plasma glucose (FPG) from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in fasting plasma insulin from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in fasting plasma glucose (FPG) from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in fasting insulin from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in HOMA-IR index from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in weight from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in weight from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in waist circumference from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in waist circumference from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in body mass index (BMI) from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in body mass index (BMI) from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in index of central obesity (ICO) from baseline and between groups
timeFrame: 6 weeks
measure: Absolute change in index of central obesity (ICO) from baseline and between groups
timeFrame: 12 weeks
measure: Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: AOU Policlinico S.Orsola-Malpighi
Study officials:
affiliation: AOU Policlinico S. Orsola-Malpighi
name: Arrigo F.G. Cicero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: