Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk In… (NCT07515573) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals
Italy50 participantsStarted 2026-05-04
Plain-language summary
This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, Omega-3 Index, selected inflammatory and liver-related markers, and endothelial reactivity.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged 18 to 79 years
* Individuals in primary cardiovascular prevention
* Estimated 10-year cardiovascular risk \<10%
* Screening non-HDL-C between 140 and 220 mg/dL, or screening LDL-C between 110 and 190 mg/dL
* Ability to communicate adequately, to be understood, and to comply with the study requirements
* Willingness to participate in the study and provision of written, signed, and dated informed consent
Exclusion Criteria:
* Triglycerides \>400 mg/dL at screening
* Type 1 or type 2 diabetes mellitus
* Body mass index \>35 kg/m²
* Current treatment with lipid-lowering drugs or use of dietary supplements active on lipid metabolism
* Antihypertensive treatment not stabilized for at least 3 months
* Known clinically significant alterations of thyroid, hepatic, and/or renal function
* Women of childbearing potential not using adequate contraceptive methods
* Pregnancy or breastfeeding
* Any medical or surgical condition that, in the investigator's judgment, could make adherence to the protocol difficult or inconsistent, compromise participant safety, or interfere with study completion
* Known intolerance or hypersensitivity to any component of the study products
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)