Metabolic Effect of an Innovative Chitosan Formulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia, Overweight and Obesity

Intervention / Treatment
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* Device: Medical Device (Kaptufat®)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment<br>Medical Device (Kaptufat®) | Device: Medical Device (Kaptufat®)<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Oral administration: 3 tablets twice a day before the main meals<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device