Tolerance Study of the Dietary Supplement Valedia

Phase 1

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Valedia

• Registration Number: NCT02790489
• Lead Sponsor: Valbiotis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-06
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valedia	Valedia	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The response during an oral glucide tolerance test after a standardized breakfast	10 weeks	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)

Trial Locations

Locations (1)

Centre d'Investigation Clinique; 🇫🇷 Clermont-Ferrand, France