A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group Clinical Trial With an Open-Label Extension to Evaluate the Effects of a Combination Dietary Supplement (Cardiol Forte) on Lipid and Glycemic Parameters in Subjects at Low Cardiovascular Risk With Suboptimal Cholesterol Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Phase 1 (Weeks 0 to 8) is quadruple-masked (participant, care provider, investigator, outcomes assessor). Phase 2 (Weeks 8 to 16) is an open-label extension in which all participants receive Cardiol Forte; therefore, no masking applies during Phase 2.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Weeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.
干预措施: Placebo (Other)
Placebo
Weeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.
干预措施: Cardiol Forte (Dietary Supplement)
Dietary supplement - Cardiol Forte
Weeks 0-8: double-blind phase; Cardiol Forte, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.
干预措施: Cardiol Forte (Dietary Supplement)
结局指标
主要结局
Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)
时间窗: Baseline to Week 8 (Day 56 ± 3 days)
Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
次要结局
- Change from baseline in total cholesterol (TC)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in low-density lipoprotein cholesterol (LDL-C)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in triglycerides (TG)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in high-density lipoprotein cholesterol (HDL-C)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in very-low-density lipoprotein cholesterol (VLDL-C)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in remnant cholesterol(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in fasting plasma glucose(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in triglyceride-glucose index (TyG index)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in aspartate aminotransferase (AST)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in alanine aminotransferase (ALT)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in gamma-glutamyl transferase (gamma-GT)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in hepatic steatosis index (HSI)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in fatty liver index (FLI)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in uric acid(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in high-sensitivity C-reactive protein (hs-CRP)(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in endothelial reactivity(Baseline to Week 8 (Day 56 ± 3 days))
- Change from baseline in Omega-3 Index(Baseline to Week 8 (Day 56 ± 3 days))