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
Sponsored by
About this trial
This is an interventional prevention trial for Elevated Blood Pressure focused on measuring Dietary supplement, Plant extracts
Eligibility Criteria
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of Diastolic Blood Pressure
Description
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of fasting blood glycemia
Description
Glycemia (in mg/dL), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of the fasting blood concentration of triglycerides
Description
Triglycerides (in g/L), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of the fasting blood concentration of total cholesterol
Description
Total cholesterol (in g/L), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of the fasting blood concentration of HDL cholesterol
Description
HDL cholesterol (in g/L), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of the fasting blood concentration of non-HDL cholesterol
Description
non-HDL cholesterol (in g/L), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of the fasting blood concentration of LDL cholesterol
Description
LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of fasting blood concentration of hsCRP
Description
hsCRP (in mg/L), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of body weight
Description
Body weight (in kg), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of waist circumference
Description
Waist circumference (in cm), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of hip circumference
Description
Hip circumference (in cm), TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of waist hip Ratio
Description
Waist Hip Ratio, TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Evolution of cardiovascular disease risk
Description
Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo
Time Frame
V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Title
Delay of occurence of pharmacological treatment requirement for hypertension from V1
Description
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
Time Frame
V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique SAPONE
Phone
+33 5 17 06 84 80
Email
veronique.sapone@valbiotis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Bargetto
Phone
+33 5 17 06 84 80
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Menzel, MD
Organizational Affiliation
BioTeSys GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
BioTeSys
City
Esslingen
ZIP/Postal Code
73728
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
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