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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05469503
Other study ID # VCT-009
Secondary ID 2022-A00131-42
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 15, 2022
Est. completion date December 1, 2024

Study information

Verified date April 2024
Source Valbiotis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 410
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
TOTUM-854
12 weeks of TOTUM-854 supplementation
Placebo
12 weeks of placebo supplementation

Locations

Country Name City State
Bulgaria 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
France CHU Clermont Ferrand PIC/CIC Inserm 1405 Clermont-Ferrand
Poland Vitamed Galaj i Cichomski sp.j Bydgoszcz
Poland Centrum Medyczne Linden Kraków
Poland Przychodnia Zespolu Lekarza Rodzinnego "Medyk" Slupca
Poland Centrum Medyczne Oporów Wroclaw

Sponsors (2)

Lead Sponsor Collaborator
Valbiotis Excelya

Countries where clinical trial is conducted

Bulgaria,  France,  Poland, 

Outcome

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