HypercholesterolemiaCHITOCHOLNCT05188430
Metabolic Effect of an Innovative Chitosan Formulation
A study testing Medical Device (Kaptufat®) in people with Hypercholesterolemia and Overweight and Obesity, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Overweight and Obesity
- What is being tested?
- Medical Device (Kaptufat®)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 3 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation
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
- Being tested
- Medical Device (Kaptufat®), Placebo
- Keywords
- Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device
- Medical subject headings
- Hypercholesterolemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
Oral administration: 3 tablets twice a day before the main meals
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Medical Device (Kaptufat®) Receives: Device: Medical Device (Kaptufat®) |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (23)
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
Measured: 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
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
Measured: 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
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion3 Sep 2022 (estimated)
- Study completion3 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arrigo F.G. Cicero, University of Bologna
- Investigators
- Arrigo F.G. Cicero, MD, PhD, Principal investigator, AOU Policlinico S. Orsola-Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188430
- Sponsor's protocol ID
- Chito_RCT2022
- Acronym
- CHITOCHOL
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation
- ClinicalTrials.gov ID
- NCT05188430
- Acronym / sponsor ID
- CHITOCHOL / Chito_RCT2022
- Conditions
- Hypercholesterolemia, Overweight and Obesity
- Keywords
- Hypercholesterolemia, Overweight, Class I obesity, Low-density lipoprotein cholesterol, Lipids, Chitosan, Medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 3 Sep 2022 (estimated)
- Study completion
- 3 Sep 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Device: Medical Device (Kaptufat®)Medical Device (Kaptufat®) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical 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 | Device | Active treatment |
| PlaceboOral administration: 3 tablets twice a day before the main meals | Other | Placebo |
Primary outcome
Absolute change in LDL-C from baseline and between groups
Time frame: 12 weeks
Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo
23 secondary outcomes
Absolute change in LDL-C from baseline and between groups
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Absolute change in lipids ratios from baseline and between groups
Time frame: 6 weeks
Absolute change in lipid accumulation product (LAP) from baseline and between groups
Time frame: 6 weeks
Absolute change in lipids ratios from baseline and between groups
Time frame: 12 weeks
Absolute change in LAP from baseline and between groups
Time frame: 12 weeks
Absolute change in fasting plasma glucose (FPG) from baseline and between groups
Time frame: 12 weeks
Absolute change in fasting plasma insulin from baseline and between groups
Time frame: 12 weeks
Absolute change in fasting plasma glucose (FPG) from baseline and between groups
Time frame: 6 weeks
Absolute change in fasting insulin from baseline and between groups
Time frame: 6 weeks
Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups
Time frame: 6 weeks
Absolute change in HOMA-IR index from baseline and between groups
Time frame: 12 weeks
Absolute change in weight from baseline and between groups
Time frame: 12 weeks
Absolute change in weight from baseline and between groups
Time frame: 6 weeks
Absolute change in waist circumference from baseline and between groups
Time frame: 6 weeks
Absolute change in waist circumference from baseline and between groups
Time frame: 12 weeks
Absolute change in body mass index (BMI) from baseline and between groups
Time frame: 12 weeks
Absolute change in body mass index (BMI) from baseline and between groups
Time frame: 6 weeks
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
Time frame: 6 weeks
Absolute change in index of central obesity (ICO) from baseline and between groups
Time frame: 6 weeks
Absolute change in index of central obesity (ICO) from baseline and between groups
Time frame: 12 weeks
Absolute change in index of visceral adiposity index (VAI) from baseline and between groups
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arrigo F.G. Cicero, MD, PhD principal investigator
AOU Policlinico S. Orsola-Malpighi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device (Kaptufat®) in people with Hypercholesterolemia and Overweight and Obesity, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arrigo F.G. Cicero, MD, PhD (+39516362224, arrigo.cicero@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in LDL-C from baseline and between groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.