Metabolic Effect of an Innovative Chitosan Formulation (CHITOCHOL)
Primary Purpose
Hypercholesterolemia, Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Medical Device (Kaptufat®)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device
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
Sites / Locations
- AOU Policlinico S.Orsola-Malpighi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active treatment
Placebo
Arm Description
Medical Device (Kaptufat®)
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05188430
First Posted
December 9, 2021
Last Updated
December 26, 2021
Sponsor
University of Bologna
1. Study Identification
Unique Protocol Identification Number
NCT05188430
Brief Title
Metabolic Effect of an Innovative Chitosan Formulation
Acronym
CHITOCHOL
Official Title
A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
September 3, 2022 (Anticipated)
Study Completion Date
September 3, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Overweight and Obesity
Keywords
Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Medical Device (Kaptufat®)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Device
Intervention Name(s)
Medical Device (Kaptufat®)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral administration: 3 tablets twice a day before the main meals
Primary Outcome Measure Information:
Title
Absolute change in LDL-C from baseline and between groups
Description
Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Absolute change in LDL-C from baseline and between groups
Description
Absolute change in LDL-C from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups
Description
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
Title
Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups
Description
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
Title
Absolute change in lipids ratios from baseline and between groups
Description
Absolute change in lipids ratios from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in lipid accumulation product (LAP) from baseline and between groups
Description
Absolute change in LAP from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in lipids ratios from baseline and between groups
Description
Absolute change in lipids ratios from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in LAP from baseline and between groups
Description
Absolute change in LAP from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in fasting plasma glucose (FPG) from baseline and between groups
Description
Absolute change in FPG from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in fasting plasma insulin from baseline and between groups
Description
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
Title
Absolute change in fasting plasma glucose (FPG) from baseline and between groups
Description
Absolute change in FPG from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in fasting insulin from baseline and between groups
Description
Absolute change in fasting insulin from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups
Description
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
Title
Absolute change in HOMA-IR index from baseline and between groups
Description
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
Title
Absolute change in weight from baseline and between groups
Description
Absolute change in weight from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in weight from baseline and between groups
Description
Absolute change in weight from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in waist circumference from baseline and between groups
Description
Absolute change in waist circumference from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in waist circumference from baseline and between groups
Description
Absolute change in waist circumference from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in body mass index (BMI) from baseline and between groups
Description
Absolute change in BMI from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in body mass index (BMI) from baseline and between groups
Description
Absolute change in BMI from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
Description
Absolute change in VAI from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in index of central obesity (ICO) from baseline and between groups
Description
Absolute change in ICO from baseline and between groups after 6 weeks of treatment with MD compared to placebo
Time Frame
6 weeks
Title
Absolute change in index of central obesity (ICO) from baseline and between groups
Description
Absolute change in ICO from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
Title
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
Description
Absolute change in VAI from baseline and between groups after 12 weeks of treatment with MD compared to placebo
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arrigo F.G. Cicero, MD, PhD
Phone
+39516362224
Email
arrigo.cicero@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arrigo F.G. Cicero, MD, PhD
Organizational Affiliation
AOU Policlinico S. Orsola-Malpighi
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico S.Orsola-Malpighi
City
Bologna
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Metabolic Effect of an Innovative Chitosan Formulation
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