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

NCT05370625 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-07-18

No results posted yet for this study

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.

Conditions

  • Elevated Blood Pressure

Interventions

DIETARY_SUPPLEMENT

Totum-854

To compare Totum-854 with Placebo on blood pressure

DIETARY_SUPPLEMENT

Placebo

Five capsules per day to consume orally in two intakes

Sponsors & Collaborators

  • BioTeSys GmbH

    collaborator OTHER

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • Daniel Menzel, MD · BioTeSys GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2023-12-31
Completion
2024-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370625 on ClinicalTrials.gov