Hypercholesterolemia, Overweight and Obesity
Conditions
Keywords
Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device
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.
Interventions
DEVICEMedical 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
OTHERPlacebo
Oral administration: 3 tablets twice a day before the main meals
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in LDL-C from baseline and between groups | 12 weeks | Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups | 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 after 12 weeks of treatment with MD compared to placebo |
| Absolute change in lipids ratios from baseline and between groups | 6 weeks | 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 | 6 weeks | Absolute change in LAP from baseline and between groups after 6 weeks of treatment with MD compared to placebo |
| Absolute change in LAP from baseline and between groups | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 insulin from baseline and between groups | 6 weeks | Absolute change in fasting insulin from baseline and between groups after 6 weeks of treatment with MD compared to placebo |
| Absolute change in LDL-C from baseline and between groups | 6 weeks | Absolute change in LDL-C 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 | 12 weeks | 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 | 12 weeks | Absolute change in weight from baseline and between groups after 12 weeks of treatment with MD compared to placebo |
| Absolute change in waist circumference from baseline and between groups | 6 weeks | Absolute change in waist circumference from baseline and between groups after 6 weeks of treatment with MD compared to placebo |
| Absolute change in body mass index (BMI) from baseline and between groups | 12 weeks | Absolute change in BMI 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 | 6 weeks | 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 | 6 weeks | Absolute change in ICO 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 | 6 weeks | Absolute change in HOMA-IR index from baseline and between groups after 6 weeks of treatment with MD compared to placebo |
Countries
Italy
Contacts
Primary ContactArrigo F.G. Cicero, MD, PhD
Outcome results
None listed