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

July 17, 2023 updated by: Valbiotis

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Maxime Bargetto
  • Phone Number: +33 5 17 06 84 80

Study Locations

  • Germany
      • Esslingen, Germany, 73728
        • Recruiting
        • BioTeSys

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure at V4
Time Frame: V4 (12 weeks of intervention)
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
V4 (12 weeks of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of Systolic Blood Pressure
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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
Time Frame: V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valbiotis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioTeSys GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Menzel, MD, BioTeSys GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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