Clinical Study to Investigate the Effect of the Food Supplement TOTUM-070 on Lipid Metabolism in Moderately Hypercholesterolemic Subjects After 3 Months of Supplementation
试验速览
- 阶段
- 不适用
- 发起方
- Valbiotis
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Evolution of fasting blood LDL cholesterol level
研究概览
简要总结
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).
详细描述
The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).
The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be conducted in a double-blind randomized manner. The random allocation sequence will be provided sealed to the independent pharmacist (not involved in the study) by an independent statistician. The ratio of randomization between the verum and placebo groups will be 1:1. Stratification randomization will be performed according to LDL-c at V0 (<160 mg/dL / ≥ 160 mg/dL) and site.
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:
- •From 18 to 70 years (including ranges);
- •BMI of ≥18.5 and ≤35 kg/m²;
- •Moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment;
- •Weight stable within ± 5% in the last three months before V0;
- •SCORE2 - SCORE2-OP (Older Persons) Cardiovascular Risk Chart
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;
- •With a history of ischemic cardiovascular event;
- •Having undergone recent surgical procedure in the past 6 months before V0 or planned in the 5 months to come;
- •History of bariatric surgery;
- •Suffering from a severe chronic disease;
- •For women: ongoing pregnancy (as evidenced by a positive test for β-Human Chorionic Gonadotropin, i.e. > 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months before V0 or intending to become pregnant within 5 months ahead;
- •Under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit V0;
- •Under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
- •Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women
结局指标
主要结局
Evolution of fasting blood LDL cholesterol level
时间窗: Baseline (V1) and End of consumption after 12 weeks (V3)
Fasting blood LDL cholesterol level by Ultracentrifugation method
次要结局
- Evolution of Lipid profile(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of Lipid homeostasis indices(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of fasting blood LDL cholesterol level(Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4))
- Evolution of Low grade inflammation(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of body weight(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of body mass index(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of fasting glycemia(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of waist circumference(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of hip circumference(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))
- Evolution of waist to hip ratio(Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4))