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

Valbiotis400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

400

Conditions

Elevated Blood Pressure

Interventions

Totum-854DIETARY_SUPPLEMENT

To compare Totum-854 with Placebo on blood pressure

PlaceboDIETARY_SUPPLEMENT

Five capsules per day to consume orally in two intakes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

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 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

Locations (1)

BioTeSys

Esslingen am Neckar, Germany

RECRUITING

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)