This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.
Main objective The primary objective of the present trial is to assess the beneficial effect of VAL070-B compared to a placebo, on blood LDL cholesterol level in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks of consumption. Secondary objectives Secondary objectives of the study are to assess the effects of VAL070-A and VAL070-B, compared to a placebo and to each other, in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks if consumption through the following parameters: * Blood level of LDL cholesterol (VAL070-A compared to placebo and VAL070-A compared to VAL070-B), * Lipid profile: Blood levels of triglycerides, total cholesterol, HDL-cholesterol and non- HDL cholesterol, * Glycaemia, * Blood hsCRP, * Fructosamine, * Blood total free fatty acid levels, * Anthropometrics assessed by body weight (BW), waist circumference (WC), hip circumference (HC) and waist to hip ratio (WHR). Safety objectives The following parameters, analyzed at baseline and after 12 weeks of consumption, participated to the safety objectives: * Blood levels of urea and creatinine, * Blood levels of GGT, AST and ALT, * Complete blood count, * Hemodynamic measurements: heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), * Adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
Biofortis Mérieux NutriSciences Clinical Investigation Center
Saint-Herblain, France
Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Comparison between VAL070-A and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of triglycerides
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of total cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of HDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of non-HDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of glucose
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Time frame: 12 weeks
Changes in fasting blood concentrations of hsCRP
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Defined as the difference V2 (12 weeks) - V1 (baseline) in mg/L
Time frame: 12 weeks
Changes in fasting blood concentrations of fructosamine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Time frame: 12 weeks
Changes in fasting blood concentrations of total free fatty acid
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmol/L
Time frame: 12 weeks
Changes in body weight
Defined as the difference V2 (12 weeks) - V1 (baseline) in kg
Time frame: 12 weeks
Changes in waist circumference
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Time frame: 12 weeks
Changes in hip circumference
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Time frame: 12 weeks
Changes in waist to hip ratio
Defined as the difference V2 (12 weeks) - V1 (baseline)
Time frame: 12 weeks
Changes in fasting blood concentrations of urea
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmol/L
Time frame: 12 weeks
Changes in fasting blood concentrations of creatinine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Time frame: 12 weeks
Changes in fasting blood concentrations of AST (Aspartate aminotransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Time frame: 12 weeks
Changes in fasting blood concentrations of ALT (Alanine aminotransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Time frame: 12 weeks
Changes in fasting blood concentrations of GGT (Gamma glutamyltransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Time frame: 12 weeks
Changes in complete blood count
Defined as the difference V2 (12 weeks) - V1 (baseline)
Time frame: 12 weeks
Changes in heart rate
Defined as the difference V2 (12 weeks) - V1 (baseline) in bpm
Time frame: 12 weeks
Changes in systolic blood pressure
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmHg
Time frame: 12 weeks
Changes in diastolic blood pressure
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmHg
Time frame: 12 weeks