To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
NCT ID: NCT05370625
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2022-05-30
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Totum-854
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
Totum-854
To compare Totum-854 with Placebo on blood pressure
Placebo
Five capsules per day to consume orally in two intakes
Placebo
Five capsules per day to consume orally in two intakes
Interventions
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Totum-854
To compare Totum-854 with Placebo on blood pressure
Placebo
Five capsules per day to consume orally in two intakes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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BioTeSys GmbH
OTHER
Valbiotis
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Menzel, MD
Role: PRINCIPAL_INVESTIGATOR
BioTeSys GmbH
Locations
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BioTeSys
Esslingen am Neckar, , Germany
Countries
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Central Contacts
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Maxime Bargetto
Role: CONTACT
Other Identifiers
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BTS1815/21
Identifier Type: OTHER
Identifier Source: secondary_id
VCT-012
Identifier Type: -
Identifier Source: org_study_id
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