To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentric, 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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Elevated Blood Pressure

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 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

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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Accepts Healthy Volunteers

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>2.65-g dose of Totum-854 dietary supplement, a mix of 6 plant extracts. Five capsules per day to consume orally in two intakes Other names: active product | Dietary Supplement: Totum-854<br>* To compare Totum-854 with Placebo on blood pressure<br>* Other names: Active product;|
| Placebo Comparator: Placebo<br>Five capsules per day to consume orally in two intakes | Dietary Supplement: Placebo<br>* Five capsules per day to consume orally in two intakes<br>* Other names: Comparator product;|

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 | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of Diastolic Blood Pressure | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of fasting blood glycemia | Glycemia (in mg/dL), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of the fasting blood concentration of triglycerides | Triglycerides (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of the fasting blood concentration of total cholesterol | Total cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of the fasting blood concentration of HDL cholesterol | HDL cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of the fasting blood concentration of non-HDL cholesterol | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of the fasting blood concentration of LDL cholesterol | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of fasting blood concentration of hsCRP | hsCRP (in mg/L), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of body weight | Body weight (in kg), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of waist circumference | Waist circumference (in cm), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of hip circumference | Hip circumference (in cm), TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of waist hip Ratio | Waist Hip Ratio, TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Evolution of cardiovascular disease risk | Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo | V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 
| Delay of occurence of pharmacological treatment requirement for hypertension from V1 | 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 | V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplement, Plant extracts