Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk

Study Overview
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Brief Summary
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This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.

Official Title
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An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk

Conditions
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Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias, Atherosclerosis, Cardio-metabolic Risk

Intervention / Treatment
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* Dietary Supplement: TOTUM-070


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Body mass index (BMI) between 18.5 and 35 kg/m² Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (European Society of Cardiology /European Atherosclerosis Society, 2019) Fasting blood LDL cholesterol level (using Friedewald estimation method) between 1.3 and 1.9 g/L Fasting blood triglycerides level ≤ 2.2 g/L Main Exclusion Criteria: Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) With a history of ischemic cardiovascular event Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease) Fasting glucose plasma concentration > 1.26 g/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOTUM-070<br>Experimental active diet supplement TOTUM-070 taken 2 times per day | Dietary Supplement: TOTUM-070<br>* 2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of blood LDL cholesterol concentration at 6 weeks | LDL cholesterol (Friedewald method) | V1 (baseline) and V2 (6 weeks of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the fasting blood concentration of triglycerides | Triglycerides | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of total cholesterol | Total cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of HDL cholesterol | HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of non-HDL cholesterol | Non-HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of free fatty acids | Free fatty acids | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of apolipoprotein-A1 | Apolipoprotein-A1 | V1 (baseline) and V2 (6 weeks of intervention) | 
| Change from baseline of the fasting blood concentration of apolipoprotein-B | Apolipoprotein-B | V1 (baseline) and V2 (6 weeks of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts