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

Primary Purpose

Elevated Blood Pressure

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Totum-854

Placebo

About this trial

This is an interventional prevention trial for Elevated Blood Pressure focused on measuring Dietary supplement, Plant extracts

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

BioTeSysRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Totum-854

Placebo

Arm Description

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

Five capsules per day to consume orally in two intakes

Outcomes

Primary Outcome Measures

Systolic Blood Pressure at V4

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Secondary Outcome Measures

Evolution of Systolic Blood Pressure

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Evolution of Diastolic Blood Pressure

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Evolution of fasting blood glycemia

Glycemia (in mg/dL), TOTUM-854 vs placebo

Evolution of the fasting blood concentration of triglycerides

Triglycerides (in g/L), TOTUM-854 vs placebo

Evolution of the fasting blood concentration of total cholesterol

Total cholesterol (in g/L), TOTUM-854 vs placebo

Evolution of the fasting blood concentration of HDL cholesterol

HDL cholesterol (in g/L), TOTUM-854 vs placebo

Evolution of the fasting blood concentration of non-HDL cholesterol

non-HDL cholesterol (in g/L), TOTUM-854 vs placebo

Evolution of the fasting blood concentration of LDL cholesterol

LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo

Evolution of fasting blood concentration of hsCRP

hsCRP (in mg/L), TOTUM-854 vs placebo

Evolution of body weight

Body weight (in kg), TOTUM-854 vs placebo

Evolution of waist circumference

Waist circumference (in cm), TOTUM-854 vs placebo

Evolution of hip circumference

Hip circumference (in cm), TOTUM-854 vs placebo

Evolution of waist hip Ratio

Waist Hip Ratio, TOTUM-854 vs placebo

Evolution of cardiovascular disease risk

Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo

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

Full Information

NCT ID

NCT05370625

First Posted

May 6, 2022

Last Updated

July 17, 2023

Sponsor

Valbiotis

Collaborators

BioTeSys GmbH

1. Study Identification

Unique Protocol Identification Number

NCT05370625

Brief Title

To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Acronym

INSIGHT-2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 30, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valbiotis

Collaborators

BioTeSys GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elevated Blood Pressure

Keywords

Dietary supplement, Plant extracts

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Totum-854

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Five capsules per day to consume orally in two intakes

Intervention Type

Dietary Supplement

Intervention Name(s)

Totum-854

Other Intervention Name(s)

Active product

Intervention Description

To compare Totum-854 with Placebo on blood pressure

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Comparator product

Intervention Description

Five capsules per day to consume orally in two intakes

Primary Outcome Measure Information:

Title

Systolic Blood Pressure at V4

Description

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Time Frame

V4 (12 weeks of intervention)

Secondary Outcome Measure Information:

Title

Evolution of Systolic Blood Pressure

Description

Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Time Frame