Metabolic Effect of an Innovative Chitosan Formulation (NCT05188430) | Clinical Trial Compass
UnknownNot Applicable
Metabolic Effect of an Innovative Chitosan Formulation
Italy60 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change in LDL-C from baseline and between groups