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

N/AActive Not RecruitingNCT05469503

Valbiotis410 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

410

Conditions

Prehypertension Elevated Blood Pressure Blood Pressure Metabolic Syndrome

Interventions

TOTUM-854DIETARY_SUPPLEMENT

12 weeks of TOTUM-854 supplementation

PlaceboDIETARY_SUPPLEMENT

12 weeks of placebo supplementation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Multiprofile Hospital for Active Treatment Cardiology Department

Haskovo, Bulgaria

Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department

Panagyurishte, Bulgaria

Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology

Plovdiv, Bulgaria

Outcomes

Primary Outcomes

Systolic Blood Pressure at V4

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Time frame: V4 (12 weeks of intervention)

Secondary Outcomes

Evolution of Systolic Blood Pressure

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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