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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food supplement group | Experimental | Two tablets of Limicol®-NG per day (1 during or after breakfast and 1 during or after dinner) Food supplements are consumed during 3 months by healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIMICOL® NG | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution 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 %). | To baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Anthropometric parameters: weight (unit: kg) | 0 month (baseline), 1 month, 3 months |
| Body Mass Index | Anthropometric parameters: determined Body Mass Index (unit: kg/m²) |
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Inclusion Criteria:
For women
LDL cholesterol >1.3 g/L (according to Friedewald calculation);
Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
Agreeing to maintain their lifestyle habits throughout the duration of the study;
Agreeing to follow the constraints generated by the study;
Having signed the informed consent form;
Social security insured.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Coralie Berthier, PhD | Contact | 3 20 87 73 33 | +33 | coralie.berthier@pasteur-lille.fr |
| Frédéric Batteux, MD | Contact | 3.20.87.73.16 | +33 | frederic.batteux@pasteur-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric Batteux, MD | Institut Pasteur de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NutrInvest - Institut Pasteur de Lille | Recruiting | Lille | Nord | 59019 | France |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Group receiving the food supplement
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|
| 0 month (baseline), 1 month, 3 months |
| Waist circumference | Waist circumference (unit: cm) | 0 month (baseline), 1 month, 3 months |
| Blood pressure | Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg) | 0 month (baseline), 1 month, 3 months |
| Heart rate | Hemodynamic parameters: Heart rate (unit: Pul/min) | 0 month (baseline), 1 month, 3 months |
| Fasting glycemia | Carbohydrate metabolism: Fasting glycemia (unit: g/l) | 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) | 0 month (baseline), 1 month, 3 months |
| Hepatic metabolism | Creatinine, bilirubin (unit: mg/dl) | 0 month (baseline), 1 month, 3 months |
| Transaminases | Hepatic metabolism: ASAT/ALAT, GGT (unit: UI/l) | 0 month (baseline), 1 month, 3 months |
| Renal metabolism (Urea) | Renal metabolism: Urea (unit: mg/dl) | 0 month (baseline), 1 month, 3 months |
| Renal metabolism (Creatinine Phophoskinase) | Renal metabolism: CPK (unit : UI/l) | 0 month (baseline), 1 month, 3 months |
| Renal metabolism (Lactate Deshydrogenase) | Renal metabolism: LDH (unit : UI/l) | 0 month (baseline), 1 month, 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |