Metabolic Effect of an Innovative Chitosan Formulation | NCT05188430

Studies
Metabolic Effect of an Innovative Chitosan Formulation

NCT05188430

Sponsor

University of Bologna

Status

Unknown status

Last Update Posted

Jan 12, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hypercholesterolemia
Overweight and Obesity

Interventions

Medical Device (Kaptufat®)
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Estimated

Primary Completion Date

Sep 3, 2022Estimated

Completion Date

Sep 3, 2022Estimated

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 26, 2021

First Posted Date

Jan 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2021

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Active Comparator	Medical Device (Kaptufat®)	Device: Medical Device (Kaptufat®)
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arrigo F.G. Cicero, MD, PhD	Contact	+39516362224		arrigo.cicero@unibo.it

Overall Officials

Name	Affiliation	Role
Arrigo F.G. Cicero, MD, PhD	AOU Policlinico S. Orsola-Malpighi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico S.Orsola-Malpighi		Bologna			Italy

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided