Assessing a dietary supplement for lowering blood pressure
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
NA · Valbiotis · NCT05370625
This study is testing if a dietary supplement called TOTUM-854 can help people with slightly high blood pressure lower their blood pressure over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Valbiotis (industry) |
| Locations | 1 site (Esslingen) |
| Trial ID | NCT05370625 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a dietary supplement called TOTUM-854 in reducing systolic blood pressure (SBP) in individuals with moderately elevated blood pressure and Grade I hypertension. Participants will receive either the supplement or a placebo for a duration of 12 weeks, with a focus on measuring changes in blood pressure levels. The study will include individuals with specific blood pressure and BMI criteria while excluding those with certain cardiovascular conditions or significant health issues.
Who should consider this trial
Good fit: Ideal candidates are adults with office systolic blood pressure between 130 and 159 mmHg and a BMI between 18.5 and 35 kg/m².
Not a fit: Patients with known secondary hypertension or significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary approach to managing elevated blood pressure, potentially reducing the need for medication.
How similar studies have performed: While there have been studies on dietary supplements for blood pressure management, the specific approach of using TOTUM-854 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Esslingen
- BioTeSys — Esslingen, Germany (RECRUITING)
Study contacts
- Principal investigator: Daniel Menzel, MD — BioTeSys GmbH
- Study coordinator: Veronique SAPONE
- Email: veronique.sapone@valbiotis.com
- Phone: +33 5 17 06 84 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Elevated Blood Pressure, Dietary supplement, Plant extracts