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

Metabolic Syndrome Clinical Trial

— INSIGHT  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Elevated Blood Pressure
• Hypertension
• Metabolic Syndrome
• Prehypertension

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)