Blood Pressure, Elevated Blood Pressure, Metabolic Syndrome, Prehypertension
Conditions
Keywords
Diet supplement, Plant extracts, Hygiene and dietary recommendations
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTTOTUM-854
12 weeks of TOTUM-854 supplementation
DIETARY_SUPPLEMENTPlacebo
12 weeks of placebo supplementation
Sponsors
Excelya
Valbiotis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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 Main
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure at V4 | V4 (12 weeks of intervention) | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Systolic Blood Pressure | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention) | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo |
| 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) | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo |
| 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) | Glycemia (in mg/dL), TOTUM-854 vs placebo |
| 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) | Triglycerides (in g/L), TOTUM-854 vs placebo |
| 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) | Total cholesterol (in g/L), TOTUM-854 vs placebo |
| 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) | HDL cholesterol (in g/L), TOTUM-854 vs placebo |
| 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) | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo |
| 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) | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo |
| 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) | hsCRP (in mg/L), TOTUM-854 vs placebo |
| 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) | Body weight (in kg), TOTUM-854 vs placebo |
| 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) | Waist circumference (in cm), TOTUM-854 vs placebo |
| 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) | Hip circumference (in cm), TOTUM-854 vs placebo |
| 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) | Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo |
| 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) | Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his hypertension, TOTUM-854 vs placebo |
Countries
Bulgaria, France, Poland
Outcome results
None listed