Healthy Volunteer
Conditions
Keywords
Prevention, Food supplement, Hypercholesterolemia
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLIMICOL® NG
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.
Sponsors
Institut Pasteur de Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Group receiving the food supplement
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* For women * If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study, * If menopausal: without estrogenic Hormone Replacement Therapy (HRT) * 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
* Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.) * Subjects presenting triglyceridemia \> 4g/L (Friedewald) * Subject requiring immediate treatment with statin * Subject requiring immediate dietary intervention or having fluctuating eating behavior * Diabetic subjects treated or not with medication * Subjects with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the investigator, could interfere with the evaluation of the study criteria (efficacy: LDL, TG, HDL, blood sugar, blood pressure, weight; safety: markers of liver, muscle or kidney function) * Subjects who have consumed in the last 3 months food supplements or functional foods that could impact cholesterol or TG levels (phytosterol, phytostanol, red yeast rice, policosanols, beta-glucans at a dose greater than 3 g/day, probiotics) * Subjects suffering from a severe chronic condition deemed incompatible with the study by the investigator (serious digestive pathologies, renal failure, coronary pathology, immunodeficiency, heart failure, rhythm disorders, progressive tumor pathology, blood disease) * Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating disorder) * Pregnant woman or planning to become pregnant during the study period or breastfeeding * Whose state of health or concomitant treatments are judged by the principal investigator or a qualified co-investigator to be incompatible with the proper conduct of the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol | To baseline at 3 months | 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 %). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 0 month (baseline), 1 month, 3 months | Anthropometric parameters: determined Body Mass Index (unit: kg/m²) |
| Waist circumference | 0 month (baseline), 1 month, 3 months | Waist circumference (unit: cm) |
| Blood pressure | 0 month (baseline), 1 month, 3 months | Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg) |
| Heart rate | 0 month (baseline), 1 month, 3 months | Hemodynamic parameters: Heart rate (unit: Pul/min) |
| Fasting glycemia | 0 month (baseline), 1 month, 3 months | Carbohydrate metabolism: Fasting glycemia (unit: g/l) |
| Weight | 0 month (baseline), 1 month, 3 months | Anthropometric parameters: weight (unit: kg) |
| Hepatic metabolism | 0 month (baseline), 1 month, 3 months | Creatinine, bilirubin (unit: mg/dl) |
| Transaminases | 0 month (baseline), 1 month, 3 months | Hepatic metabolism: ASAT/ALAT, GGT (unit: UI/l) |
| Renal metabolism (Urea) | 0 month (baseline), 1 month, 3 months | Renal metabolism: Urea (unit: mg/dl) |
| Renal metabolism (Creatinine Phophoskinase) | 0 month (baseline), 1 month, 3 months | Renal metabolism: CPK (unit : UI/l) |
| Renal metabolism (Lactate Deshydrogenase) | 0 month (baseline), 1 month, 3 months | Renal metabolism: LDH (unit : UI/l) |
| Lipid metabolism | 0 month (baseline), 1 month, 3 months | Total cholesterol, HDL, LDL, non-HDL, Triglycerides, LDL/HDL ratio and TC/HDL ratio (unit: g/l) |
Countries
France
Contacts
Primary ContactCoralie Berthier, PhD
Backup ContactFrédéric Batteux, MD
Outcome results
None listed