NCT03052062

Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03)

Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Valbiotis · Industry
• Sex: Male
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Obese

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lipidrive	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

Timeline

• Start date: 2017-03-02
• Primary completion: 2018-07-03
• Completion: 2018-07-03
• First posted: 2017-02-14
• Last updated: 2018-07-06

Locations

1 site across 1 country: France