Tolerance Study of the Dietary Supplement Valedia

Overweight Clinical Trial

— ECPH1-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790489
• Other study ID #: 2015-A01864-45
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2016
• Last updated: August 8, 2016
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Valbiotis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• Valedia

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
Valbiotis	Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France, Laboratoire AME2P, Université Blaise Pascal, Clermont-Ferrand, France

Country where clinical trial is conducted

France, 

Outcome

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