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.
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
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
U.G.A. Nutraceuticals
Lead sponsor