Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Conditions
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Prehypertension, Elevated Blood Pressure, Blood Pressure, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: TOTUM-854
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOTUM-854<br>Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes | Dietary Supplement: TOTUM-854<br>* 12 weeks of TOTUM-854 supplementation<br>|
| Placebo Comparator: Placebo<br>Placebo comparator Seven capsules per day to consume orally in two intakes | Dietary Supplement: Placebo<br>* 12 weeks of placebo supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure at V4 | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V4 (12 weeks of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Systolic Blood Pressure | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention) | 
| Evolution of Diastolic Blood Pressure | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | 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 | Glycemia (in mg/dL), TOTUM-854 vs placebo | 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 triglycerides | Triglycerides (in g/L), TOTUM-854 vs placebo | 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 | Total cholesterol (in g/L), TOTUM-854 vs placebo | 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 | HDL cholesterol (in g/L), TOTUM-854 vs placebo | 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 | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo | 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) | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo | 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 | hsCRP (in mg/L), TOTUM-854 vs placebo | 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 | Body weight (in kg), TOTUM-854 vs placebo | 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 | Waist circumference (in cm), TOTUM-854 vs placebo | 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 | Hip circumference (in cm), TOTUM-854 vs placebo | 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) | Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo | 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 | 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 | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet supplement, Plant extracts, Hygiene and dietary recommendations