An interventional study of TOTUM-854 and Placebo in Prehypertension, Elevated Blood Pressure and Blood Pressure, sponsored by Valbiotis. Active, not recruiting at 10 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Valbiotis · Not applicable, Interventional, and Prevention
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 410 is above the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Valbiotis is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes
Dietary Supplement: TOTUM-854
Placebo comparator Seven capsules per day to consume orally in two intakes
Dietary Supplement: Placebo
12 weeks of TOTUM-854 supplementation
12 weeks of placebo supplementation
Systolic Blood Pressure at V4
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Time frame: V4 (12 weeks of intervention)
Evolution of Systolic Blood Pressure
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of Diastolic Blood Pressure
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood glycemia
Glycemia (in mg/dL), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood concentration of triglycerides
Triglycerides (in g/L), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood concentration of total cholesterol
Total cholesterol (in g/L), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood concentration of HDL cholesterol
HDL cholesterol (in g/L), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood concentration of non-HDL cholesterol
non-HDL cholesterol (in g/L), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)
LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the fasting blood hsCRP concentration
hsCRP (in mg/L), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the body weight
Body weight (in kg), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the waist circumference
Waist circumference (in cm), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the hip circumference
Hip circumference (in cm), TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Evolution of the cardiovascular disease risk (SCORE value)
Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
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
Time frame: V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention)
Started Jul 2022 (actual). Primary completion is estimated for Sep 2024, 25 months after the start.
Of 60 interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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