Tolerance Study of the Dietary Supplement Valedia

Study Overview
=================
Brief Summary
-----------------
The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters : Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea. Urinary parameters: urea, creatinine. Hemodynamic parameters: heart rate and blood pressure. Cardiac function: ECG. Weight.

Official Title
-----------------
Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Valedia


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: 25 <= BMI < 30 kg.m2 Main Exclusion Criteria: ASAT <= 1,55 microkat/L ALAT <= 1,70 microkat/L gGT <= 2,55 microkat/L 55 <= Creatinine <= 104 micromol/L (+- 10%) Bilirubin < 17,1 micromol/L (+- 10%) 1,7 <= Urea <= 8,3 mmol/L (+- 10%) us-CRP <= 5 mg/L (+- 10%) 0,70 <= Fasting glycemia <= 1,25 g/L (+- 10%) HbA1c <= 6% Medications for diabetes and/or dyslipidemia

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valedia<br>Dose 1 : 2,5 g (4 capsules) Valedia per day during 4 weeks Dose 2 : 5 g (8 capsules) Valedia per day during 4 weeks 2 weeks (wash-out period) between the 2 doses | Dietary Supplement: Valedia<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on urine urea | Urine urea | 10 weeks | 
| Effect on urine creatinine | Urine creatinine | 10 weeks | 
| Effect on fasting glycemia | Fasting blood glucose | 10 weeks | 
| Effect on insulin | Plasma insulin | 10 weeks | 
| Effect on fructosamine | Blood fructosamine | 10 weeks | 
| Effect on total cholesterol | Blood total cholesterol | 10 weeks | 
| Effect on HDL cholesterol | Blood HDL cholesterol | 10 weeks | 
| Effect on LDL cholesterol | Blood LDL cholesterol | 10 weeks | 
| Effect on triglycerides | Blood triglycerides | 10 weeks | 
| Effect on oxidized LDL cholesterol | Blood oxidized LDL cholesterol | 10 weeks | 
| Effect on inflammation | Blood us-CRP | 10 weeks | 
| Effect on AST | Blood AST | 10 weeks | 
| Effect on ALT | Blood ALT | 10 weeks | 
| Effect on gamma GT | Blood gamma GT | 10 weeks | 
| Effect on alkaline phosphatase | Blood phosphatase alkaline | 10 weeks | 
| Effect on bilirubin | Blood bilirubin | 10 weeks | 
| Effect on cardiac function | ECG | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response during an oral glucide tolerance test after a standardized breakfast | Oral glucose tolerance test (after a standardized breakfast) with glycemia and insulinemia measurements (-10 min, -5 min, +15 min, +30 min, +45 min, +60 min, +90 min, +120 min, arrival at center in fasting state) | 10 weeks |