CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

Not Applicable

Not yet recruiting

• Conditions: Atherosclerotic Disease

• Registration Number: NCT06910111
• Lead Sponsor: Certmedica International GmbH

Brief Summary

This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device. Therefore, it is a pivotal clinical investigation with a confirmatory type of design.

Detailed Description

Background and rationale The Investigational Product (formoline AtheroGuard, main ingredient: customized Polyglucosamine) administered by oral route before main meals binds fats in the stomach and intestine simply by physicochemical reaction and reduces their absorption and hydrolysis. The lower fat availability stimulates the mobilization of reserve lipids to be used for the metabolic processes and reduce the inflammatory cascade that can activate reactive cells (macrophages) in triggering atherosclerosis. Clinical data: Polyglucosamine treatment for 2 years significantly reduced Carotid Intima Media Thickness (CIMT). A recent meta-analysis has suggested a positive association between the progression of the Intima-Media Thickness (IMT) and cardiovascular risk. The results showed that interventional effects on the Carotid Intima-Media Thickness (CIMT) are also likely to reduce CV event rates.

Objective(s) The primary objective is to reduce or stabilize the increase of the arterial CIMT.

The reduction of plaque area, the change in plaques deposits, body weight, abdominal circumference, BMI, blood pressure, blood glucose, insulin resistance, insulin blood levels, hsCRP, oxidative stress, and the improvement of the lipid profile (reduction of triglycerides, total cholesterols, LDL and increase of HDL) are considered secondary objectives.

The safety objectives are to demonstrate the safety of formoline AtheroGuard 750 mg tablets administered for 12 months Design Two arms multicenter randomized double-blind placebo controlled clinical investigation

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study Start: 2025-04-01
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound)	Screening visit/baseline; after 6 months; after 12 months of treatment	To demonstrate the benefit of formoline AtheroGuard reducing or stabilizing CIMT and plaques volume in patients suffering from dyslipidemia, hypertension, or type II diabetes.

Trial Locations

Locations (3)

Pisa University Hospital - Clinical Research Unit; 🇮🇹 Pisa, Tuscany, Italy

University Gabriele d'Annunzio Chieti - Pescara; 🇮🇹 Chieti, Italy

S. Maria della Misericordia Hospital; 🇮🇹 Perugia, Italy