To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Elevated Blood Pressure Clinical Trial

— INSIGHT-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370625
• Other study ID #: VCT-012
• Secondary ID: BTS1815/21
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Valbiotis
• Contact: Veronique SAPONE
• Phone: +33 5 17 06 84 80
• Email: veronique.sapone[@]valbiotis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• Totum-854
To compare Totum-854 with Placebo on blood pressure
• Placebo
Five capsules per day to consume orally in two intakes

Locations

Country	Name	City	State
Germany	BioTeSys	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Valbiotis	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure at V4	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo	V4 (12 weeks of intervention)
Secondary	Evolution of Systolic Blood Pressure	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of Diastolic Blood Pressure	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of fasting blood glycemia	Glycemia (in mg/dL), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of the fasting blood concentration of triglycerides	Triglycerides (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of the fasting blood concentration of total cholesterol	Total cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of the fasting blood concentration of HDL cholesterol	HDL cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of the fasting blood concentration of non-HDL cholesterol	non-HDL cholesterol (in g/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of the fasting blood concentration of LDL cholesterol	LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of fasting blood concentration of hsCRP	hsCRP (in mg/L), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of body weight	Body weight (in kg), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of waist circumference	Waist circumference (in cm), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of hip circumference	Hip circumference (in cm), TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of waist hip Ratio	Waist Hip Ratio, TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	Evolution of cardiovascular disease risk	Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)
Secondary	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	V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)