Clinical trial NCT05469503: Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
Official title: A 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: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prehypertension
Elevated Blood Pressure
Blood Pressure
Metabolic Syndrome
Keywords: Diet supplement
Plant extracts
Hygiene and dietary recommendations
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: Excelya
First posted: 2022-07-21
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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 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

Primary outcomes:
measure: Systolic Blood Pressure at V4
timeFrame: V4 (12 weeks of intervention)
Secondary outcomes:
measure: Evolution of Systolic Blood Pressure
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of Diastolic Blood Pressure
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood glycemia
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood concentration of triglycerides
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood concentration of total cholesterol
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood concentration of HDL cholesterol
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood concentration of non-HDL cholesterol
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the fasting blood hsCRP concentration
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the body weight
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the waist circumference
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the hip circumference
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Evolution of the cardiovascular disease risk (SCORE value)
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
measure: Delay of occurence of pharmacological treatment requirement for hypertension from V1
timeFrame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Other outcomes:
Locations:
city: Haskovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Cardiology Department
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department
city: Plovdiv
country: Bulgaria
facility: Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center XX- Sofia EOOD
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand PIC/CIC Inserm 1405
city: Bydgoszcz
country: Poland
facility: Vitamed Gałaj i Cichomski sp.j
city: Kraków
country: Poland
facility: Centrum Medyczne Linden
city: Słupca
country: Poland
facility: Przychodnia Zespołu Lekarza Rodzinnego "Medyk"
city: Wrocław
country: Poland
facility: Centrum Medyczne Oporów
Study officials:
affiliation: Centrum Medyczne Linden
name: Katarzyna Pałka, Dr
role: PRINCIPAL_INVESTIGATOR
References: