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| Name | Class |
|---|---|
| University Hospital, Clermont-Ferrand | OTHER |
| Université Blaise Pascal, Clermont-Ferrand | OTHER |
| Biofortis Mérieux NutriSciences | OTHER |
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The objectives of this clinical study are to determine the tolerance of dietary supplement Lipidrive through the evaluation of several parameters :
Primary objectives of this study :
Evaluate the effects of two doses of the product on:
Secondary objectives of this study:
Evaluate the effects of the highest dose on:
- Adiponectin, leptin, TNF-α, and the evolution kinetics of blood glucose and blood insulin levels following a standard breakfast, with or without the acute administration of the Lipidrive dietary supplement.
Two questionnaires (one on eating habits over 3 days and another on physical and sports activities) will be completed at various times (cf. below). A "satisfaction" questionnaire will also be completed at the end of the study.
A serum bank will be created (ghrelin, resistin, GIP, GLP-1, IL-6, IL-1 beta, CCK), and stools will be collected at V2 and V5 for subsequent microbiota analysis (aliquoting performed by the AME2P laboratory, which will send the samples to BIOFORTIS Nantes at the end of the trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipidrive | Experimental | Dose 1 : 2,6 g (4 capsules) Lipidrive per day during 12 weeks Dose 2 : 5,2 g (8 capsules) Lipidrive per day during 12 weeks, 2 weeks (wash-out period) between the 2 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipidrive | Dietary Supplement | LipiDrive, 4 to 8 capsules per day, oral administration. Dose 1: 2.6 g Lipidrive per day Dose 2: 5.2 g Lipidrive per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fasting blood glucose | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in fasting blood glucose | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in fasting insulinemia | Defined as the difference V3 (12 weeks) - V2 (baseline)) in mUI/L | 12 weeks |
| Changes in fasting insulinemia | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mUI/L | 26 weeks |
| Changes in fasting HOMA-IR | Defined as the difference V3 (12 weeks) - V2 (baseline) | 12 weeks |
| Changes in fasting HOMA-IR | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in glycated hemoglobin | Defined as the difference V3 (12 weeks) - V2 (baseline) in % | 12 weeks |
| Changes in glycated hemoglobin | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in % | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fasting blood adiponectin | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in fasting blood leptin | Defined as the difference V5 (26 weeks) - V4 (14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in stools microbiota | Changes between V5 (26 weeks) and V4 (14 weeks) | 26 weeks |
Inclusion Criteria:
Following the biological screening conducted during the inclusion visit, run-in subjects will be included at the following visit according to the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle Pickering, MD, PhD | Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France | Principal Investigator |
| Sébastien Peltier, PhD | Valbiotis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Changes in fasting fructosamin | Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L | 12 weeks |
| Changes in fasting fructosamin | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L | 26 weeks |
| Changes in fasting total cholesterol | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in fasting total cholesterol | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in fasting HDL cholesterol | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in fasting HDL cholesterol | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in fasting LDL cholesterol | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in fasting LDL cholesterol | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in fasting triglycerides | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in fasting triglycerides | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in oxidized LDL | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L | 12 weeks |
| Changes in oxidized LDL | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in us-CRP | Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/L | 12 weeks |
| Changes in us-CRP | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L | 26 weeks |
| Changes in blood creatinine | Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL | 12 weeks |
| Changes in blood creatinine | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL | 26 weeks |
| Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase) | Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L | 12 weeks |
| Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L | 26 weeks |
| Changes in fasting blood levels of GGT (Gamma glutamyltransferase) | Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L | 12 weeks |
| Changes in fasting blood levels of GGT (Gamma glutamyltransferase) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L | 26 weeks |
| Changes in fasting alkaline phosphatase | Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L | 12 weeks |
| Changes in fasting alkaline phosphatase | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L | 26 weeks |
| Changes in fasting blood bilirubin | Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L | 12 weeks |
| Changes in fasting blood bilirubin | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L | 26 weeks |
| Changes in fasting blood urea | Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL | 12 weeks |
| Changes in fasting blood urea | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL | 26 weeks |
| Changes in heart rate | Defined as the difference V3 (12 weeks) - V2 (baseline) in bpm | 12 weeks |
| Changes in heart rate | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in bpm | 26 weeks |
| Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure) | Defined as the difference V3 (12 weeks) - V2 (baseline) in mmHg (mean of the two measures for each parameter at each visit) | 12 weeks |
| Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmHg (mean of the two measures for each parameter at each visit) | 26 weeks |
| Changes in cardiac function (electrocardiogram, ECG) | Defined as the difference V3 (12 weeks) - V2 (baseline) | 12 weeks |
| Changes in cardiac function (electrocardiogram, ECG) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in body weight | Defined as the difference V3 (12 weeks) - V2 (baseline) in kg | 12 weeks |
| Changes in body weight | Defined as the difference V5 (26 weeks) - V4 (14 weeks) in kg | 26 weeks |
| Changes in WC (waist circumference) | Defined as the difference V3 (12 weeks) - V2 (baseline) | 12 weeks |
| Changes in WC (waist circumference) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in HC (hip circumference) | Defined as the difference V3 (12 weeks) - V2 (baseline) | 12 weeks |
| Changes in HC (hip circumference) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in WHR (waist to hip ratio) | Defined as the difference V3 (12 weeks) - V2 (baseline) | 12 weeks |
| Changes in WHR (waist to hip ratio) | Defined as the difference V5 (26 weeks) - V4 (14 weeks) | 26 weeks |
| Changes in body composition | Defined as the difference V3 (12 weeks) - V2 (baseline), using bioelectric impendence analysis | 12 weeks |
| Changes in body composition | Defined as the difference V5 (26 weeks) - V4 (14 weeks), using bioelectric impendence analysis | 26 weeks |
| 26 weeks |
| Changes in the evolution of glycemia during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of glycemia at 15, 30, 45, 60, 90 and 120 minutes between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the incremental area under the curve (glycemia response) during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of incremental Area Under the Curve (iAUC) of glycemia between T0 and T120 minutes following a standard breakfast (iAUC0-120min) and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the glycemia Cmax during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of glycemia Cmax between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the glycemia Δpeak during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of Δpeak (difference from the baseline at Cmax), between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the evolution of insulinemia during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUI/L) of insulinemia at 15, 30, 45, 60, 90 and 120 minutes between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the incremental area under the curve (insulinemia response) during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUI/L) of incremental Area Under the Curve (iAUC) of insulinemia between T0 and T120 minutes following a standard breakfast (iAUC0-120min) and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the insulinemia Cmax during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of insulinemia Cmax between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| Changes in the insulinemia Δpeak during an oral glucid tolerance test | Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of Δpeak (difference from the baseline at Cmax), between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120 | 26 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |