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

Not Applicable

Active, not recruiting

• Conditions: Metabolic Syndrome; Prehypertension; Elevated Blood Pressure; Blood Pressure

• Registration Number: NCT05469503
• Lead Sponsor: Valbiotis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure at V4	V4 (12 weeks of intervention)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Secondary Outcome Measures

Name	Time	Method
Evolution of the fasting blood concentration of triglycerides	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Triglycerides (in g/L), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of non-HDL cholesterol	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	non-HDL cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of the body weight	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Body weight (in kg), TOTUM-854 vs placebo
Evolution of the waist circumference	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Waist circumference (in cm), TOTUM-854 vs placebo
Evolution of Systolic Blood Pressure	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Evolution of Diastolic Blood Pressure	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Evolution of the fasting blood glycemia	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Glycemia (in mg/dL), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of total cholesterol	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Total cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of HDL cholesterol	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	HDL cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo
Evolution of the fasting blood hsCRP concentration	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	hsCRP (in mg/L), TOTUM-854 vs placebo
Evolution of the hip circumference	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Hip circumference (in cm), TOTUM-854 vs placebo
Evolution of the cardiovascular disease risk (SCORE value)	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo
Delay of occurence of pharmacological treatment requirement for hypertension from V1	V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)	Delay 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

Trial Locations

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

Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department; 🇧🇬 Plovdiv, Bulgaria

Diagnostic Consultative Center XX- Sofia EOOD; 🇧🇬 Sofia, Bulgaria

CHU Clermont Ferrand PIC/CIC Inserm 1405; 🇫🇷 Clermont-Ferrand, France

Vitamed Gałaj i Cichomski sp.j; 🇵🇱 Bydgoszcz, Poland

Centrum Medyczne Linden; 🇵🇱 Kraków, Poland

Przychodnia Zespołu Lekarza Rodzinnego "Medyk"; 🇵🇱 Słupca, Poland

Centrum Medyczne Oporów; 🇵🇱 Wrocław, Poland