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PrehypertensionINSIGHTNCT05469503

Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

A study testing TOTUM-854 in people with Prehypertension and Elevated Blood Pressure, run by Valbiotis at 10 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. Read more about this study

Who is it for?
Ages 18 to 75 years
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
410 participants
Where
10 sitesin 3 countries
Study dates
15 Jul 2022to 1 Dec 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
  • No healthy volunteers
  • 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 before the randomization and agreeing to keep them unchanged throughout the study

Main Exclusion Criteria:

  • Known or suspected secondary hypertension
  • Subjects with a very high Cardio Vascular risk SCORE2 or SCORE2-OP according to their risk regions: (Subjects <50 years old: ≥7.5%; Subjects between 50 and 69 years old: ≥10%; Subjects ≥70 years old: ≥15%)
  • 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 an 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 inclusion
  • Newly diagnosed or suffering from a non-treated or uncontrolled metabolic disorder such as diabetes, dyslipidemia, thyroidal dysfunction or other metabolic disorder
  • 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

10 sites in 3 countries.

10 sites in 3 countries

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment Cardiology Department

    Haskovo

  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department

    Panagyurishte

  • Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology

    Plovdiv

  • Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department

    Plovdiv

  • Diagnostic Consultative Center XX- Sofia EOOD

    Sofia

Other trials in Bulgaria

Poland4 sites

  • Vitamed Gałaj i Cichomski sp.j

    Bydgoszcz

  • Centrum Medyczne Linden

    Krakow

  • Przychodnia Zespołu Lekarza Rodzinnego "Medyk"

    Słupca

  • Centrum Medyczne Oporów

    Wroclaw

Other trials in Poland

France1 site

  • CHU Clermont Ferrand PIC/CIC Inserm 1405

    Clermont-Ferrand

Other trials in France

About this study

Official title: A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.

Being tested
TOTUM-854, Placebo
Keywords
Diet supplement, Plant extracts, Hygiene and dietary recommendations
Medical subject headings
Prehypertension, Hypertension, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOTUM-854Dietary supplement

    12 weeks of TOTUM-854 supplementation

  • PlaceboDietary supplement

    12 weeks of placebo supplementation

Study groups in NCT05469503
Study groupRoleWhat they receive
TOTUM-854ExperimentalExperimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes
Receives: Dietary Supplement: TOTUM-854
PlaceboPlacebo comparatorPlacebo comparator Seven 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.

  1. Systolic Blood Pressure at V4

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

    Measured: V4 (12 weeks of intervention)

Secondary outcomes (14)

  1. Evolution of Systolic Blood Pressure

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

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)

  2. Evolution of Diastolic Blood Pressure

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

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  3. Evolution of the fasting blood glycemia

    Glycemia (in mg/dL), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  4. Evolution of the fasting blood concentration of triglycerides

    Triglycerides (in g/L), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  5. Evolution of the fasting blood concentration of total cholesterol

    Total cholesterol (in g/L), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  6. Evolution of the fasting blood concentration of HDL cholesterol

    HDL cholesterol (in g/L), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  7. Evolution of the fasting blood concentration of non-HDL cholesterol

    non-HDL cholesterol (in g/L), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  8. Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)

    LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  9. Evolution of the fasting blood hsCRP concentration

    hsCRP (in mg/L), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  10. Evolution of the body weight

    Body weight (in kg), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  11. Evolution of the waist circumference

    Waist circumference (in cm), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  12. Evolution of the hip circumference

    Hip circumference (in cm), TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  13. Evolution of the cardiovascular disease risk (SCORE value)

    Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo

    Measured: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

  14. Delay of occurence of pharmacological treatment requirement for hypertension from V1

    Delay 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 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469503
Sponsor's protocol ID
VCT-009
Other IDs
2022-A00131-42
Acronym
INSIGHT
Status last verified
Apr 2024
First submitted
18 Jul 2022
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing TOTUM-854 in people with Prehypertension and Elevated Blood Pressure, run by Valbiotis at 10 sites in 3 countries.

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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Bulgaria, Poland, France. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT05469503.

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 23 Apr 2024.

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