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

This monocentric, randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to 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. In routine clinical practice, many individuals in primary cardiovascular prevention have mildly to moderately altered lipid levels that do not necessarily require immediate pharmacological treatment, but may still benefit from non-pharmacological strategies aimed at improving cardiometabolic risk factors. Cardiol Forte contains omega-3 fatty acids, artichoke leaf extract, bergamot extract, olive extract standardized in hydroxytyrosol, coenzyme Q10, folic acid, and vitamin E, and may have favorable effects on lipid metabolism and related cardiometabolic parameters.

A total of 50 participants will be enrolled. After screening and a 14- to 28-day run-in period with standardized dietary and behavioral instructions, eligible 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 enter an 8-week open-label extension and will receive Cardiol Forte. Study product will be administered orally at a dose of 2 capsules per day, preferably 15 to 30 minutes before dinner. The total duration of participation will therefore be 16 weeks, in addition to the run-in period.

The primary objective is to compare the change in plasma non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to the end of the 8-week double-blind phase between Cardiol Forte and placebo. Secondary objectives include evaluation of changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglycerides, remnant cholesterol, fasting plasma glucose, Omega-3 Index, triglyceride-glucose index, liver-related indices, uric acid, high-sensitivity C-reactive protein, and endothelial reactivity. Participants will attend screening, randomization, end-of-double-blind, and final study visits. Blood samples for efficacy and safety assessments will be collected at scheduled visits, Omega-3 Index will be assessed at baseline, Week 8, and Week 16, and endothelial reactivity will be assessed by flow-mediated dilation. Safety will be monitored throughout the study through adverse event collection, vital signs, clinical assessments, and laboratory evaluations.

• Change from baseline in total cholesterol (TC) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in low-density lipoprotein cholesterol (LDL-C) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in triglycerides (TG) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in high-density lipoprotein cholesterol (HDL-C) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in very-low-density lipoprotein cholesterol (VLDL-C) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in remnant cholesterol [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in fasting plasma glucose [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in Omega-3 Index [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in triglyceride-glucose index (TyG index) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in aspartate aminotransferase (AST) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in alanine aminotransferase (ALT) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]
• Change from baseline in gamma-glutamyl transferase (gamma-GT) [Time frame: Baseline to Week 8 (Day 56 ± 3 days)]