Metabolic Effect of an Innovative Chitosan Formulation

University of Bologna60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia Overweight and Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Metabolic Effect of an Innovative Chitosan Formulation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts