Elevated Blood Pressure
Conditions
Keywords
Dietary supplement, Plant extracts
Brief summary
The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.
Interventions
DIETARY_SUPPLEMENTTotum-854
To compare Totum-854 with Placebo on blood pressure
DIETARY_SUPPLEMENTPlacebo
Five capsules per day to consume orally in two intakes
Sponsors
BioTeSys GmbH
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
Yes
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 prior to randomization and agreeing to keep them unchanged throughout the study Main
Exclusion criteria
* Known or suspected secondary hypertension * 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 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 screening * 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 Diastolic Blood Pressure | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo |
| Evolution of fasting blood glycemia | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Glycemia (in mg/dL), TOTUM-854 vs placebo |
| Evolution of the fasting blood concentration of triglycerides | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Triglycerides (in g/L), TOTUM-854 vs placebo |
| Evolution of the fasting blood concentration of total cholesterol | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Total cholesterol (in g/L), TOTUM-854 vs placebo |
| Evolution of the fasting blood concentration of HDL cholesterol | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | HDL cholesterol (in g/L), TOTUM-854 vs placebo |
| Evolution of the fasting blood concentration of non-HDL cholesterol | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo |
| Evolution of the fasting blood concentration of LDL cholesterol | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo |
| Evolution of Systolic Blood Pressure | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo |
| Evolution of body weight | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Body weight (in kg), TOTUM-854 vs placebo |
| Evolution of waist circumference | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Waist circumference (in cm), TOTUM-854 vs placebo |
| Evolution of hip circumference | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Hip circumference (in cm), TOTUM-854 vs placebo |
| Evolution of waist hip Ratio | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Waist Hip Ratio, TOTUM-854 vs placebo |
| Evolution of cardiovascular disease risk | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo |
| Delay of occurence of pharmacological treatment requirement for hypertension from V1 | V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | Dealy 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 |
| Evolution of fasting blood concentration of hsCRP | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | hsCRP (in mg/L), TOTUM-854 vs placebo |
Countries
Germany
Contacts
Primary ContactVeronique SAPONE
Backup ContactMaxime Bargetto
Outcome results
None listed