NCT06910111

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

Cardio and Atherosclerosis Prevention and Treatment Via Fat Uptake REduction With a Specified Biopolymer: One Year Randomized Double-blind Placebo-controlled Clinical Investigation to Improve Vascular Health in Patients at Cardiovascular Risk: CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atherosclerotic Disease

Interventions

Type	Name	Description
DEVICE	Polyglucosamine	The treatment will continue for 12 months administering a customized Polyglucosamine (formoline AtheroGuard) (twice/day) before the two main meals for a total of 4 tabs/day (each tab consists of 750 mg). Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months
DEVICE	Placebo	2x 2 Placebo tablets The treatment will continue for 12 months administering Placebo (twice/day) before the two main meals for a total of 4 tabs/day. Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

3 sites across 1 country: Italy