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

NCT06910111 | Not Yet Recruiting

• 1 other identifier: CIV-IT-24-07-048534
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Atherosclerotic Disease

Keywords

CAPTURE formoline AtheroGuard

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound)

  To demonstrate the benefit of formoline AtheroGuard reducing or stabilizing CIMT and plaques volume in patients suffering from dyslipidemia, hypertension, or type II diabetes.

  Screening visit/baseline; after 6 months; after 12 months of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo consists of tablets

Device: Placebo

Device

EXPERIMENTAL

750 mg tablets main ingredient Polyglucosamin

Device: Polyglucosamine

Interventions

Polyglucosamine DEVICE

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 DEVICE

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

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of both genders, with CIMT \> 1.00 mm suffering from hypertension and/or type II diabetes and/or hypercholesterolemia, under stable treatment for these conditions since at least 6 months.
• Age between 45-65
• BMI \> 26 ≤35
• Total cholesterol ≥ 200 ≤ 240 mg/dL
• BP mm Hg: Mx ≥ 135 ≤ 160 ; Mn ≥ 75 ≤ 90 the subject must remain 10 min at rest in clinostatic position before measurement
• Blood glucose Mn ≥ 80 ; Mx ≤ 130 mg/dL
• The subjects suffering from hypertension, and/or diabetes, and/or hypercholesterolemia can be admitted provided that the diseases under chronic treatment are mitigated with no more than 2 drugs. By drug we mean any formulation (in tablets, capsules, fluid etc..) containing one or more active ingredients. This therapy has to be administered 4 hours before or after the product under evaluation.
• ESC score (European Society of Cardiology) \< 10
• Informed consent must be obtained prior to participation.
• Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
• Subjects must be willing and able to give informed consent/assent for participation in the study.
• Negative pregnancy test for women with childbearing capacity.

You may not qualify if:

• Age \< 45 or \> 65 years.
• Pregnancy or breastfeeding. During the study, women of reproductive age will have to use reliable contraceptive methods.
• Mx BP \> 160 Mn \> 90 despite a treatment of 6 months with common antihypertensive
• Total cholesterol \> 240 mg/dL despite a treatment of 6 months with the common hypolipemic drugs
• Morning blood glucose \> 130 mg/dL despite a treatment of 6 months with common oral hypoglycemic drugs
• BMI \> 35
• ESC score (European Society of Cardiology) ≥ 10
• Myocardial infarction
• Neurological disorders
• Cancer
• Gout
• Kidney dysfunction (creatinine \> 3 mg/dl)
• Liver dysfunction (ALT \> 40 U/L)
• COPD (FEV \< 80% of predicted value)
• Psychiatric diseases

Sponsors & Collaborators

• Certmedica International GmbH: lead
• Evidilya S.r.l.: collaborator

Study Sites (3)

Pisa University Hospital - Clinical Research Unit

Pisa, Tuscany, 56126, Italy

Location

University Gabriele d'Annunzio Chieti - Pescara

Chieti, 66100, Italy

Location

S. Maria della Misericordia Hospital

Perugia, 06129, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arms multicenter randomized double-blind placebo controlled clinical investigation

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)