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

NCT05469503 | Active Not Recruiting DMC

• 2 other identifiers: VCT-0092022-A00131-42
• Study Type: interventional
• Target: 410
• Locations: 3 countries
• Sites: 10

Brief 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. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.

Conditions

Prehypertension; Elevated Blood Pressure; Blood Pressure; Metabolic Syndrome

Keywords

Diet supplement; Plant extracts; Hygiene and dietary recommendations

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure at V4

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

  V4 (12 weeks of intervention)

Secondary Outcomes (14)

• Evolution of Systolic Blood Pressure

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

• Evolution of Diastolic Blood Pressure

  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

  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

  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

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

Study Arms (2)

TOTUM-854

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo comparator Seven capsules per day to consume orally in two intakes

Dietary Supplement: Placebo

Interventions

TOTUM-854 DIETARY_SUPPLEMENT

12 weeks of TOTUM-854 supplementation

TOTUM-854

Placebo DIETARY_SUPPLEMENT

12 weeks of placebo supplementation

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Valbiotis: lead
• Excelya: collaborator

Study Sites (10)

Multiprofile Hospital for Active Treatment Cardiology Department

Haskovo, Bulgaria

Location

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

Panagyurishte, Bulgaria

Location

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

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department

Plovdiv, Bulgaria

Location

Diagnostic Consultative Center XX- Sofia EOOD

Sofia, Bulgaria

Location

CHU Clermont Ferrand PIC/CIC Inserm 1405

Clermont-Ferrand, France

Location

Vitamed Gałaj i Cichomski sp.j

Bydgoszcz, Poland

Location

Centrum Medyczne Linden

Krakow, Poland

Location

Przychodnia Zespołu Lekarza Rodzinnego "Medyk"

Słupca, Poland

Location

Centrum Medyczne Oporów

Wroclaw, Poland

Location

MeSH Terms

Conditions

Prehypertension; Hypertension; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katarzyna Pałka, Dr

  Centrum Medyczne Linden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: July 15, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

PL (4); BU (5); FR (1)