NCT05594979终止不适用
An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Valbiotis
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change from baseline of blood LDL cholesterol concentration at 6 weeks
研究概览
简要总结
This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Body mass index (BMI) between 18.5 and 35 kg/m²
- •Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain...) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (European Society of Cardiology /European Atherosclerosis Society, 2019)
- •Fasting blood LDL cholesterol level (using Friedewald estimation method) between 1.3 and 1.9 g/L
- •Fasting blood triglycerides level ≤ 2.2 g/L
排除标准
- •Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations
- •Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- •With a history of ischemic cardiovascular event
- •Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease)
- •Fasting glucose plasma concentration > 1.26 g/L
结局指标
主要结局
Change from baseline of blood LDL cholesterol concentration at 6 weeks
时间窗: V1 (baseline) and V2 (6 weeks of intervention)
LDL cholesterol (Friedewald method)
次要结局
- Change from baseline of the fasting blood concentration of total cholesterol(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of apolipoprotein-A1(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of apolipoprotein-B(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of non-HDL cholesterol(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of triglycerides(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of HDL cholesterol(V1 (baseline) and V2 (6 weeks of intervention))
- Change from baseline of the fasting blood concentration of free fatty acids(V1 (baseline) and V2 (6 weeks of intervention))
研究者
研究点 (2)
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