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

N/ANot Yet RecruitingNCT07515573

U.G.A. Nutraceuticals50 enrolled

Overview

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.

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.

Interventions

Cardiol ForteDIETARY_SUPPLEMENT

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.

PlaceboOTHER

Matching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Ability to communicate adequately, to be understood, and to comply with the study requirements * Willingness to participate in the study and provision of written, signed, and dated informed consent Exclusion Criteria: * 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 * Antihypertensive treatment not stabilized for at least 3 months * Known clinically significant alterations of thyroid, hepatic, and/or renal function * Women of childbearing potential not using adequate contraceptive methods * Pregnancy or breastfeeding * Any medical or surgical condition that, in the investigator's judgment, could make adherence to the protocol difficult or inconsistent, compromise participant safety, or interfere with study completion * Known intolerance or hypersensitivity to any component of the study products

Outcomes

Primary Outcomes

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).