Atherosclerotic DiseaseCAPTURENCT06910111
CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)
A study testing Polyglucosamine in people with Atherosclerotic Disease, run by Certmedica International GmbH at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Atherosclerotic Disease
- What is being tested?
- Polyglucosamine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Apr 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- IBS
- Anemia (HB < 10 g/dl)
- Inability or unreliability of the Food Intake Assessment [4]
- Hypersensitivity to polyglucosamine
- Any medical condition or abnormality of clinical laboratory tests that needs systemic pharmacological treatment besides treatment for hypertension, type II diabetes or hypercholesterolemia. This means that local treatments will be allowed.
- Vulnerable subjects: incapacitated, immunocompromised, or other conditions which may bring to a condition of vulnerability.
- Subjects under emergency circumstances
- Treatment with orally applicable drugs exceeding application in the morning and in the late evening
- Current treatment with GLP-1 agonists, fosinopril, acarbose.
- In the case of treatment with food supplements the subject can be enrolled after 1 month of product withdrawal.
- Known allergy to crustaceans or one of the ingredients
- Chronic constipation
- Intestinal obstruction
- Intake of long-term medications that significantly slow down intestinal activity
- Current participation in any other investigational trials
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
University Gabriele d'Annunzio Chieti - Pescara
Chieti, 66100
Beatrice Feragalli, Prof, 00398713551, beatrice.feragalli@unich.it
Beatrice Feragalli, Prof
S. Maria della Misericordia Hospital
Perugia, 06129
Matteo Pirro, Prof, 0039755784020, matteo.piro@unipg.it
Matteo Pirro, Prof
Pisa University Hospital - Clinical Research Unit
Pisa, Tuscany, 56126
Stefano Masi, Prof, 0039-50995732, stefano.masi@unipi.it
About this study
Official title: 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)
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.
Read the 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
- Being tested
- Polyglucosamine, Placebo
- Keywords
- CAPTURE formoline AtheroGuard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyglucosamineDevice
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
PlaceboDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo consists of tablets Receives: Device: Placebo |
| Device | Experimental | 750 mg tablets main ingredient Polyglucosamin Receives: Device: Polyglucosamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit/baseline; after 6 months; after 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic DiseaseStudies 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
- Model description
- Two arms multicenter randomized double-blind placebo controlled clinical investigation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910111
- Sponsor's protocol ID
- CIV-IT-24-07-048534
- Acronym
- CAPTURE
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06910111
- Acronym / sponsor ID
- CAPTURE / CIV-IT-24-07-048534
- Conditions
- Atherosclerotic Disease
- Keywords
- CAPTURE formoline AtheroGuard
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms multicenter randomized double-blind placebo controlled clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboPlacebo consists of tablets |
| Device | Experimental | Device: Polyglucosamine750 mg tablets main ingredient Polyglucosamin |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (30 listed)
- 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
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 |
|---|---|---|
| PolyglucosamineThe 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 | Device |
| Placebo2x 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 | Device | Placebo |
Primary outcome
The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglucosamine in people with Atherosclerotic Disease, run by Certmedica International GmbH at 3 sites 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 12 inclusion and 30 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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound) (time frame: Screening visit/baseline; after 6 months; after 12 months of treatment). 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 4 Apr 2025.