To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure (INSIGHT-2)

Valbiotis

Status: Enrolling

Conditions: Elevated Blood Pressure

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05370625

VCT-012

BTS1815/21 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Totum-854

Experimental group

Description:

2.65-g dose of Totum-854 dietary supplement, a mix of 6 plant extracts. Five capsules per day to consume orally in two intakes Other names: active product

Treatment:

Dietary Supplement: Totum-854

Placebo

Placebo Comparator group

Description:

Five capsules per day to consume orally in two intakes

Treatment:

Dietary Supplement: Placebo