Tolerance Study of the Dietary Supplement Valedia | NCT02790489 | Trialant

Tolerance Study of the Dietary Supplement Valedia | NCT02790489 | Trialant

Sponsor/Collaborators Module

Collaborators

Name	Class
Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France	UNKNOWN
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Valedia	Experimental	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Contacts/Locations Module

Condition Browse Module