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

Valbiotis

Status: Active, not recruiting

Conditions: Prehypertension; Elevated Blood Pressure; Metabolic Syndrome; Blood Pressure

Treatments: Dietary Supplement: Placebo; Dietary Supplement: TOTUM-854

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05469503

2022-A00131-42 (Other Identifier)

VCT-009

Details and patient eligibility

About

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.

Enrollment: 410 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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410 participants in 2 patient groups, including a placebo group

TOTUM-854

Experimental group

Description:

Experimental active diet supplement TOTUM-854 3.71-g dose. Seven capsules per day to consume orally in two intakes

Treatment:

Dietary Supplement: TOTUM-854

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo