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

A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Syndrome; Prehypertension; Blood Pressure; Elevated Blood Pressure
• Intervention / Treatment: Dietary supplement: TOTUM-854; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Haskovo, Bulgaria
    • Multiprofile Hospital for Active Treatment Cardiology Department
  • Panagyurishte, Bulgaria
    • Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department
  • Plovdiv, Bulgaria
    • Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology
  • Plovdiv, Bulgaria
    • Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department
  • Sofia, Bulgaria
    • Diagnostic Consultative Center XX- Sofia EOOD
• France
  • Clermont-Ferrand, France
    • CHU Clermont Ferrand PIC/CIC Inserm 1405
• Poland
  • Bydgoszcz, Poland
    • Vitamed Gałaj i Cichomski sp.j
  • Kraków, Poland
    • Centrum Medyczne Linden
  • Słupca, Poland
    • Przychodnia Zespołu Lekarza Rodzinnego "Medyk"
  • Wrocław, Poland
    • Centrum Medyczne Oporow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOTUM-854; Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes	Dietary supplement: TOTUM-854; 12 weeks of TOTUM-854 supplementation
Placebo Comparator: Placebo; Placebo comparator Seven capsules per day to consume orally in two intakes	Dietary supplement: Placebo; 12 weeks of placebo supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure at V4	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo	V4 (12 weeks of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Valbiotis
• Collaborators: Excelya
• Investigators: Principal Investigator: Katarzyna Pałka, Dr, Centrum Medyczne Linden

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Plant extracts; Diet supplement; Hygiene and dietary recommendations
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Hypertension; Metabolic Syndrome; Prehypertension
• Other Study ID Numbers: VCT-009; 2022-A00131-42 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No