Metabolic Syndrome Clinical Trial
— INSIGHTOfficial title:
A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
Verified date | April 2024 |
Source | Valbiotis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 410 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
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 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Multiprofile Hospital for Active Treatment Cardiology Department | Haskovo | |
Bulgaria | Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department | Panagyurishte | |
Bulgaria | Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology | Plovdiv | |
Bulgaria | Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department | Plovdiv | |
Bulgaria | Diagnostic Consultative Center XX- Sofia EOOD | Sofia | |
France | CHU Clermont Ferrand PIC/CIC Inserm 1405 | Clermont-Ferrand | |
Poland | Vitamed Galaj i Cichomski sp.j | Bydgoszcz | |
Poland | Centrum Medyczne Linden | Kraków | |
Poland | Przychodnia Zespolu Lekarza Rodzinnego "Medyk" | Slupca | |
Poland | Centrum Medyczne Oporów | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
Valbiotis | Excelya |
Bulgaria, France, Poland,
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 | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of Diastolic Blood Pressure | Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood glycemia | Glycemia (in mg/dL), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood concentration of triglycerides | Triglycerides (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood concentration of total cholesterol | Total cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood concentration of HDL cholesterol | HDL cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood concentration of non-HDL cholesterol | non-HDL cholesterol (in g/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method) | LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the fasting blood hsCRP concentration | hsCRP (in mg/L), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the body weight | Body weight (in kg), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the waist circumference | Waist circumference (in cm), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the hip circumference | Hip circumference (in cm), TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | Evolution of the cardiovascular disease risk (SCORE value) | Systematic Coronary Risk Estimation value from Heartscore calculator, TOTUM-854 vs placebo | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) | |
Secondary | 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 | V1 (baseline), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks) and V5 (4 weeks after the stop of intervention) |
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