NCT05469503Unknown不适用
A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Valbiotis
- 入组人数
- 410
- 试验地点
- 12
- 主要终点
- Systolic Blood Pressure at V4
研究概览
简要总结
This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure < 100 mmHg
- •Body Mass Index (BMI) between 18.5 and 35 kg/m²
- •Weight stable within ± 5 % in the last three months
- •No significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to keep them unchanged throughout the study
排除标准
- •Known or suspected secondary hypertension
- •Subjects with a very high Cardio Vascular risk SCORE2 or SCORE2-OP according to their risk regions: (Subjects <50 years old: ≥7.5%; Subjects between 50 and 69 years old: ≥10%; Subjects ≥70 years old: ≥15%)
- •Known hypertensive retinopathy and/or hypertensive encephalopathy
- •History of spontaneous or drug-induced angioedema
- •Clinically significant valvular heart disease or severe aortic stenosis
- •History of an acute coronary syndrome (non-ST elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to inclusion
- •Newly diagnosed or suffering from a non-treated or uncontrolled metabolic disorder such as diabetes, dyslipidemia, thyroidal dysfunction or other metabolic disorder
- •Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator
结局指标
主要结局
Systolic Blood Pressure at V4
时间窗: V4 (12 weeks of intervention)
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
次要结局
- Evolution of the fasting blood concentration of triglycerides(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood concentration of non-HDL cholesterol(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the body weight(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the waist circumference(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of Systolic Blood Pressure(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of Diastolic Blood Pressure(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood glycemia(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood concentration of total cholesterol(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood concentration of HDL cholesterol(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the fasting blood hsCRP concentration(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the hip circumference(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Evolution of the cardiovascular disease risk (SCORE value)(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
- Delay of occurence of pharmacological treatment requirement for hypertension from V1(V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention))
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)Prediabetic StateDiabetes type2DysglycemiaNCT04423302Valbiotis636
招募中
不适用
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLDNon-Alcoholic Fatty Liver DiseaseNCT06704321Valbiotis70
已完成
不适用
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic RiskPrediabetic StateDysglycemiaOverweight and ObesityNCT05369585Valbiotis20
已完成
不适用
Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic SubjectsHypercholesterolemiaCardiovascular Risk FactorDyslipidemiasOverweight and ObesityAtherosclerosisNCT04760951Valbiotis120
招募中
不适用
To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood PressureElevated Blood PressureNCT05370625Valbiotis400