Obese Clinical Trial
Official title:
Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.
The objectives of this clinical study are to determine the tolerance of dietary supplement
Lipidrive through the evaluation of several parameters :
- Various blood biological parameters
- Urinary parameters
- Hemodynamic indicators
- Cardiac function
- Anthropometric variables
Primary objectives of this study :
Evaluate the effects of two doses of the product on:
- Various blood biological parameters for tolerance (preprandial): blood glucose, insulin,
HOMA-IR, glycated hemoglobin, fructosamine, total cholesterol, triglycerides,
HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT,
alkaline phosphatase, bilirubin, urea.
- Urinary parameters: urea, creatinine.
- Hemodynamic indicators: heart rate and blood pressure.
- Cardiac function: ECG.
- Anthropometric variables: weight, waist, hips, waist/hip ratio, body composition using
bioelectric impendence analysis.
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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