Study Comparing Two Dietary Supplements and Placebo on Cholesterol Levels in Adults with Mild Hypercholesterolemia

What this Trial Is About

Researchers are evaluating the effects of two different dietary supplement formulations on lipid profiles in adults with mild hypercholesterolemia who have not responded to the Mediterranean diet. This single-center, randomized, parallel-group, single-blind, placebo-controlled clinical study includes 99 participants and aims to compare the impact of these supplements on cholesterol levels and other cardiovascular risk markers. Participants are divided into three groups one receiving an innovative formulation Test Product A, another receiving a classic formulation Test Product B, and a placebo group. All groups take their assigned product daily for the first 8 weeks during the double-blind phase. Afterward, all participants continue with Test Product A for an additional 8 weeks in an open-label phase to observe longer-term effects and whether differences between the initial groups change when all receive the same supplement. Participants will attend scheduled visits at screening 35 days before baseline, enrollment 28 days before baseline, randomization baseline, interim visit at 8 weeks, and final visit at 16 weeks. Researchers will monitor various blood markers including LDL cholesterol, total cholesterol, HDL cholesterol, triglycerides, and apolipoprotein B, as well as blood pressure and body measurements. Compliance, tolerability, lifestyle adherence, and adverse events are also tracked throughout the study, which lasts about 16 weeks from baseline.

Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia