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

Primary Purpose

Prehypertension, Elevated Blood Pressure, Blood Pressure

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

TOTUM-854

Placebo

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Diet supplement, Plant extracts, Hygiene and dietary recommendations

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

Multiprofile Hospital for Active Treatment Cardiology DepartmentRecruiting
Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology DepartmentRecruiting
Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology
Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology DepartmentRecruiting
Diagnostic Consultative Center XX- Sofia EOODRecruiting
CHU Clermont Ferrand PIC/CIC Inserm 1405Recruiting
Vitamed Gałaj i Cichomski sp.jRecruiting
Centrum Medyczne LindenRecruiting
Przychodnia Zespołu Lekarza Rodzinnego "Medyk"Recruiting
Centrum Medyczne OporówRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TOTUM-854

Placebo

Arm Description

Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes

Placebo comparator Seven 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 the 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 (Friedewald method)

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

Evolution of the fasting blood hsCRP concentration

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

Evolution of the body weight

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

Evolution of the waist circumference

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

Evolution of the hip circumference

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

Evolution of the cardiovascular disease risk (SCORE value)

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

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

Full Information

NCT ID

NCT05469503

First Posted

July 18, 2022

Last Updated

July 17, 2023

Sponsor

Valbiotis

Collaborators

Excelya

1. Study Identification

Unique Protocol Identification Number

NCT05469503

Brief Title

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

Acronym

INSIGHT

Official Title

A 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

July 15, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valbiotis

Collaborators

Excelya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Prehypertension, Elevated Blood Pressure, Blood Pressure, Metabolic Syndrome

Keywords

Diet supplement, Plant extracts, Hygiene and dietary recommendations

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

Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator Seven capsules per day to consume orally in two intakes

Intervention Type

Dietary Supplement

Intervention Name(s)

TOTUM-854

Intervention Description

12 weeks of TOTUM-854 supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

12 weeks of placebo supplementation

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

V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)

Title

Evolution of Diastolic Blood Pressure

Description

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

Time Frame