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Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals
Sponsor: U.G.A. Nutraceuticals
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, selected inflammatory and liver-related markers, and endothelial reactivity.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group Clinical Trial With an Open-Label Extension to Evaluate the Effects of a Combination Dietary Supplement (Cardiol Forte) on Lipid and Glycemic Parameters in Subjects at Low Cardiovascular Risk With Suboptimal Cholesterol Levels
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-05-04
Completion Date
2028-05-04
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, BO, Italy