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
Parallel
Cardiol Forte
Dietary supplementEach 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
Other interventionMatching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.
Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)
Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Change from baseline in total cholesterol (TC)
Between-group comparison of the change from baseline in plasma TC after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Between-group comparison of the change from baseline in plasma LDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Change from baseline in triglycerides (TG)
Between-group comparison of the change from baseline in plasma TG after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Change from baseline in high-density lipoprotein cholesterol (HDL-C)
Between-group comparison of the change from baseline in plasma HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Change from Week 8 to Week 16 in total cholesterol (TC)
Exploratory evaluation of the change in plasma TC from Week 8 to Week 16 during the open-label extension, when all participants receive Cardiol Forte.
Change from Week 8 to Week 16 in low-density lipoprotein cholesterol (LDL-C)
Exploratory evaluation of the change in plasma LDL-C from Week 8 to Week 16 during the open-label extension, when all participants receive Cardiol Forte.
Change from Week 8 to Week 16 in triglycerides (TG)
Exploratory evaluation of the change in plasma TG from Week 8 to Week 16 during the open-label extension, when all participants receive Cardiol Forte.
Change from Week 8 to Week 16 in high-density lipoprotein cholesterol (HDL-C)
Exploratory evaluation of the change in plasma HDL-C from Week 8 to Week 16 during the open-label extension, when all participants receive Cardiol Forte.
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