Clinical trial NCT05370625: To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Keywords: Dietary supplement
Plant extracts
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2022-05-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Systolic Blood Pressure at V4
timeFrame: V4 (12 weeks of intervention)
Secondary outcomes:
measure: Evolution of Systolic Blood Pressure
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of Diastolic Blood Pressure
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of fasting blood glycemia
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of the fasting blood concentration of triglycerides
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of the fasting blood concentration of total cholesterol
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of the fasting blood concentration of HDL cholesterol
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of the fasting blood concentration of non-HDL cholesterol
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of the fasting blood concentration of LDL cholesterol
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of fasting blood concentration of hsCRP
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of body weight
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of waist circumference
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of hip circumference
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of waist hip Ratio
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Evolution of cardiovascular disease risk
timeFrame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
measure: Delay of occurence of pharmacological treatment requirement for hypertension from V1
timeFrame: V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References: