This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Institut Pasteur de Lille
Lille, France
Unité d'Investigation Clinique Biofortis Mérieux NutriSciences
Paris, France
Biofortis Mérieux NutriSciences
Saint-Herblain, France
Biotesys
Esslingen am Neckar, Germany
Fasting blood LDL cholesterol concentration at V3 with ultracentrifugation method
Fasting blood LDL concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo
Time frame: V3 (24 weeks of intervention)
Evolution of the fasting blood LDL cholesterol concentration with ultracentrifugation method
Fasting blood LDL cholesterol concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo
Time frame: V1 (baseline) and V2 (12 weeks of intervention)
Evolution of the fasting blood concentration of triglycerides
Triglycerides (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of total cholesterol
Total cholesterol (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of HDL cholesterol
HDL cholesterol (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of non-HDL cholesterol
non-HDL cholesterol (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)
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LDL cholesterol (in g/L, Friedewald method), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of free fatty acids
Free fatty acids (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood glycemia
Glycemia (in mg/dL), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood hsCRP concentration
hsCRP (in mg/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of apolipoprotein-A1
Apolipoprotein-A1 (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentration of apolipoprotein-B
Apolipoprotein-B (in g/L), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of atherogenic index
Atherogenic index, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of atherogenic coefficient
Atherogenic coefficient, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of Cardiac risk ratio 1
Cardiac risk ratio 1, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of Cardiac risk ratio 2
Cardiac risk ratio 2, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of Apo-B/Apo-A1 ratio
Apo-B/Apo-A1 ratio, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the body weight
Body weight (in kg), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the waist circumference
Waist circumference (in cm), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the hip circumference
Hip circumference (in cm), TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the waist to hip ratio
Waist to hip ratio, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Delay of occurence of pharmacological treatment requirement for hypercholesterolemia 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 hypercholesterolemia, TOTUM-070 vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the cardiovascular disease risk (SCORE value)
Systematic Coronary Risk Estimation value from Heartscore calculator
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)