NCT05370625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

May 6, 2022

Last Update Submit

July 17, 2023

Conditions

Elevated Blood Pressure

Keywords

Dietary supplementPlant extracts

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure at V4

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

    V4 (12 weeks of intervention)

Secondary Outcomes (15)

  • Evolution of Systolic Blood Pressure

    V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

  • Evolution of Diastolic Blood Pressure

    V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

  • Evolution of fasting blood glycemia

    V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

  • Evolution of the fasting blood concentration of triglycerides

    V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

  • Evolution of the fasting blood concentration of total cholesterol

    V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)

  • +10 more secondary outcomes

Study Arms (2)

Totum-854

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Five capsules per day to consume orally in two intakes

Dietary Supplement: Placebo

Interventions

Totum-854DIETARY_SUPPLEMENT

To compare Totum-854 with Placebo on blood pressure

Also known as: Active product
Totum-854
PlaceboDIETARY_SUPPLEMENT

Five capsules per day to consume orally in two intakes

Also known as: Comparator product
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys

Esslingen am Neckar, 73728, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Daniel Menzel, MD

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique SAPONE

CONTACT

+33 5 17 06 84 80veronique.sapone@valbiotis.com

Maxime Bargetto

CONTACT

+33 5 17 06 84 80

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

May 30, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

DE(1)