Status:
UNKNOWN
Metabolic Effect of an Innovative Chitosan Formulation
Lead Sponsor:
University of Bologna
Conditions:
Hypercholesterolemia
Overweight and Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05188430
Start Date
March 1 2022
End Date
September 3 2022
Last Update
January 12 2022
Active Locations (1)
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1
AOU Policlinico S.Orsola-Malpighi
Bologna, Italy