Elevated Blood PressureINSIGHT-2NCT05370625
To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
A study testing Totum-854 in people with Elevated Blood Pressure, run by Valbiotis at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- Totum-854
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Maxime Bargetto contact
About this study
Official title: 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
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
- Being tested
- Totum-854, Placebo
- Keywords
- Dietary supplement, Plant extracts
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totum-854Dietary supplement
Also called Active product
To compare Totum-854 with Placebo on blood pressure
PlaceboDietary supplement
Also called Comparator product
Five capsules per day to consume orally in two intakes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Totum-854 |
| Placebo | Placebo comparator | Five capsules per day to consume orally in two intakes Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure at V4
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Measured: V4 (12 weeks of intervention)
Secondary outcomes (15)
Evolution of Systolic Blood Pressure
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of Diastolic Blood Pressure
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood glycemia
Glycemia (in mg/dL), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of triglycerides
Triglycerides (in g/L), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of total cholesterol
Total cholesterol (in g/L), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of HDL cholesterol
HDL cholesterol (in g/L), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of non-HDL cholesterol
non-HDL cholesterol (in g/L), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of LDL cholesterol
LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood concentration of hsCRP
hsCRP (in mg/L), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of body weight
Body weight (in kg), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist circumference
Waist circumference (in cm), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of hip circumference
Hip circumference (in cm), TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist hip Ratio
Waist Hip Ratio, TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of cardiovascular disease risk
Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo
Measured: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Delay of occurence of pharmacological treatment requirement for hypertension from V1
Dealy 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
Measured: V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start30 May 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370625
- Sponsor's protocol ID
- VCT-012
- Other IDs
- BTS1815/21
- Acronym
- INSIGHT-2
- Status last verified
- Jul 2023
- First submitted
- 6 May 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05370625
- Acronym / sponsor ID
- INSIGHT-2 / VCT-012
- Conditions
- Elevated Blood Pressure
- Keywords
- Dietary supplement, Plant extracts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 30 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totum-854 | Experimental | Dietary Supplement: Totum-8542.65-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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFive capsules per day to consume orally in two intakes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totum-854Also: Active productTo compare Totum-854 with Placebo on blood pressure | Dietary supplement | Totum-854 |
| PlaceboAlso: Comparator productFive capsules per day to consume orally in two intakes | Dietary supplement | Placebo |
Primary outcome
Systolic Blood Pressure at V4
Time frame: V4 (12 weeks of intervention)
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
15 secondary outcomes
Evolution of Systolic Blood Pressure
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of Diastolic Blood Pressure
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood glycemia
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of triglycerides
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of total cholesterol
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of HDL cholesterol
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of non-HDL cholesterol
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of the fasting blood concentration of LDL cholesterol
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of fasting blood concentration of hsCRP
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of body weight
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist circumference
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of hip circumference
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of waist hip Ratio
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Evolution of cardiovascular disease risk
Time frame: V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Delay of occurence of pharmacological treatment requirement for hypertension from V1
Time frame: V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Bargetto contact
Daniel Menzel, MD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totum-854 in people with Elevated Blood Pressure, run by Valbiotis at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronique SAPONE (+33 5 17 06 84 80, veronique.sapone@valbiotis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure at V4 (time frame: V4 (12 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.