To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure (INSIGHT-2)

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

The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.

Study Overview

• Status: Recruiting
• Conditions: Elevated Blood Pressure
• Intervention / Treatment: Dietary supplement: Totum-854; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronique SAPONE; Phone Number: +33 5 17 06 84 80; Email: veronique.sapone@valbiotis.com
• Study Contact Backup: Name: Maxime Bargetto; Phone Number: +33 5 17 06 84 80

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • Recruiting
    • Biotesys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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 prior to randomization and agreeing to keep them unchanged throughout the study

Main Exclusion Criteria:

• Known or suspected secondary hypertension
• 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 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 screening
• 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; 2.65-g dose of Totum-854 dietary supplement, a mix of 6 plant extracts. Five capsules per day to consume orally in two intakes Other names: active product	Dietary supplement: Totum-854; To compare Totum-854 with Placebo on blood pressure; Other Names: Active product
Placebo Comparator: Placebo; Five capsules per day to consume orally in two intakes	Dietary supplement: Placebo; Five capsules per day to consume orally in two intakes; Other Names: Comparator product

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	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of Diastolic Blood Pressure	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood glycemia	Glycemia (in mg/dL), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of triglycerides	Triglycerides (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of total cholesterol	Total cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of HDL cholesterol	HDL cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of non-HDL cholesterol	non-HDL cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of LDL cholesterol	LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood concentration of hsCRP	hsCRP (in mg/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of body weight	Body weight (in kg), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist circumference	Waist circumference (in cm), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of hip circumference	Hip circumference (in cm), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist hip Ratio	Waist Hip Ratio, TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of cardiovascular disease risk	Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Delay of occurence of pharmacological treatment requirement for hypertension from V1	Dealy 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 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

Collaborators and Investigators

• Sponsor: Valbiotis
• Collaborators: BioTeSys GmbH
• Investigators: Principal Investigator: Daniel Menzel, MD, BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Dietary supplement; Plant extracts
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: VCT-012; BTS1815/21 (Other Identifier: Biotesys)

Drug and device information, study documents

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