Atherosclerosis, Cardio-metabolic Risk, Cardiovascular Risk Factor, Dyslipidemias, Hypercholesterolemia
Conditions
Keywords
Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTTOTUM-070
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes
Sponsors
University Hospital, Clermont-Ferrand
Valbiotis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of blood LDL cholesterol concentration at 6 weeks | V1 (baseline) and V2 (6 weeks of intervention) | LDL cholesterol (Friedewald method) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the fasting blood concentration of total cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | Total cholesterol |
| Change from baseline of the fasting blood concentration of HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | HDL cholesterol |
| Change from baseline of the fasting blood concentration of non-HDL cholesterol | V1 (baseline) and V2 (6 weeks of intervention) | Non-HDL cholesterol |
| Change from baseline of the fasting blood concentration of triglycerides | V1 (baseline) and V2 (6 weeks of intervention) | Triglycerides |
| Change from baseline of the fasting blood concentration of apolipoprotein-A1 | V1 (baseline) and V2 (6 weeks of intervention) | Apolipoprotein-A1 |
| Change from baseline of the fasting blood concentration of apolipoprotein-B | V1 (baseline) and V2 (6 weeks of intervention) | Apolipoprotein-B |
| Change from baseline of the fasting blood concentration of free fatty acids | V1 (baseline) and V2 (6 weeks of intervention) | Free fatty acids |
Countries
France
Outcome results
None listed