The goal of this clinical trial is to observe a decrease in plasma LDL cholesterol concentration of 10% (or 0.20g/L) in subjects with untreated moderate hypercholesterolemia after 3 months of consumption of the Limicol®-NG food supplement, compared with a historical placebo group
The objective is to evaluate the effect of the Limicol®-NG food supplement during the 3 months of taking it (after 1 and 3 months of consumption versus T0) and comparison versus placebo history of the evolution over time (from 0 to 3 months) of the following parameters: * Weight, * BMI, * Waist circumference, * Systolic and diastolic blood pressures, * Resting heart rate. * Fasting blood sugar * LDL cholesterol * Non-HDL cholesterol (NHC) * Total cholesterol (TC) * HDL cholesterol * Triglycerides (TG) * LDL/HDL and TC/HDL ratios, * Safety parameters measured from blood samples at VS and V2: ASAT, ALAT, Gamma-GT, Creatine Kinase, Lactate DeHydrogenase, Bilirubin, Creatinine, and Urea.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
35
All subjects will consume 2 tablets per day during the entire intervention period, i.e. 12 weeks between V0 and V2, distributed as follows: 1 tablet in the morning at the end of or after breakfast (no taking on an empty stomach) and 1 tablet in the evening during dinner. If a dose is missed, 2 tablets can be taken at the next dose.
NutrInvest - Institut Pasteur de Lille
Lille, Nord, France
RECRUITINGEvolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol
Historical placebo comparison of the evolution over time (from 0 to 3 months) of plasma LDL cholesterol concentration measured according to the Friedwald method (in g/L and %).
Time frame: To baseline at 3 months
Weight
Anthropometric parameters: weight (unit: kg)
Time frame: 0 month (baseline), 1 month, 3 months
Body Mass Index
Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
Time frame: 0 month (baseline), 1 month, 3 months
Waist circumference
Waist circumference (unit: cm)
Time frame: 0 month (baseline), 1 month, 3 months
Blood pressure
Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
Time frame: 0 month (baseline), 1 month, 3 months
Heart rate
Hemodynamic parameters: Heart rate (unit: Pul/min)
Time frame: 0 month (baseline), 1 month, 3 months
Fasting glycemia
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
Time frame: 0 month (baseline), 1 month, 3 months
Lipid metabolism
Total cholesterol, HDL, LDL, non-HDL, Triglycerides, LDL/HDL ratio and TC/HDL ratio (unit: g/l)
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Time frame: 0 month (baseline), 1 month, 3 months
Hepatic metabolism
Creatinine, bilirubin (unit: mg/dl)
Time frame: 0 month (baseline), 1 month, 3 months
Transaminases
Hepatic metabolism: ASAT/ALAT, GGT (unit: UI/l)
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Urea)
Renal metabolism: Urea (unit: mg/dl)
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Creatinine Phophoskinase)
Renal metabolism: CPK (unit : UI/l)
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Lactate Deshydrogenase)
Renal metabolism: LDH (unit : UI/l)
Time frame: 0 month (baseline), 1 month, 3 months