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Clinical Trials in Italy / NCT07515573
Starting soon Not applicable

Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals

NCT07515573 · tracked via the Priya Life Science Italy tracker
Sponsor
U.G.A. Nutraceuticals
Phase
Not applicable
Started
2026-05-04
Last updated
2026-04-20

Condition(s) studied

Dyslipidemia

Investigational drug(s) / intervention(s)

Cardiol FortePlacebo

Cardiol Forte: Each capsule of Cardiol Forte contains fish oil 5025 TG 550.488 mg, corresponding to total omega-3 fatty acids 456 mg, of which eicosapentaenoic acid (EPA) 275 mg and docosahexaenoic acid (DHA) 137 mg; artichoke extract leaves (Altilix®) 150 mg; Citrus bergamia Risso et Poit. dry extract (BPF®) 100 mg; Cynara scolymus L. dry extract 10 mg; olive fruit dry extract standardized to 9% hydroxytyrosol 55.600 mg, corresponding to hydroxytyrosol 5.004 mg; coenzyme Q10 10 mg; folic acid 0.3 mg; and vitamin E 12 mg.

Placebo: Matching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C) — Baseline to Week 8 (Day 56 ± 3 days)
    Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).

Trial sites (1)

FacilityCityRegionStatus
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy Bologna BO

Other trials for the same condition

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia Active, not recruiting
Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07515573 on ClinicalTrials.gov ↗ ← All trials in Italy