Metabolic Effect of an Innovative Chitosan Formulation

NCT05188430 | Unknown

• 1 other identifier: Chito_RCT2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Overweight and Obesity

Keywords

Hypercholesterolemia; Overweight; Class I obesity; Low-density lipoprotein cholesterol; Lipids; Chitosan; Medical device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Absolute change in LDL-C from baseline and between groups

  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

  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

  6 weeks

• Absolute change in lipids ratios from baseline and between groups

  6 weeks

• Absolute change in lipid accumulation product (LAP) from baseline and between groups

  6 weeks

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Medical Device (Kaptufat®)

Device: Medical Device (Kaptufat®)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Medical Device (Kaptufat®) DEVICE

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

Active treatment

Placebo OTHER

Oral administration: 3 tablets twice a day before the main meals

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

AOU Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

MeSH Terms

Conditions

Hypercholesterolemia; Overweight; Obesity

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arrigo F.G. Cicero, MD, PhD

  AOU Policlinico S. Orsola-Malpighi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arrigo F.G. Cicero, MD, PhD

CONTACT

+39516362224; arrigo.cicero@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 12, 2022
• Study Start: March 1, 2022
• Primary Completion: September 3, 2022
• Study Completion: September 3, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

IT (1)