Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
PrediabetesType 2 DiabetesHypertriglyceridemiaObesityDiseaseInsulin Resistance
Interventions
DIETARY_SUPPLEMENT

Totum-63

Each randomized subject will consume 8 capsules daily of either active (5200 mg of Totum-63) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

DIETARY_SUPPLEMENT

Placebo

Each randomized subject will consume 8 capsules daily of placebo (5064 mg of maltodextrine) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

Trial Locations (6)

21000

Clinical Center of Vojvodina / Poseidon CRO, Novi Sad

44800

Biofortis Mérieux NutriSciences Clinical Investigation Center, Saint-Herblain

59019

Institut Pasteur de Lille, Lille

T23 R50R

Atlantia Food Clinical Trials, Cork

Unknown

Clinical center of Kragujevac, / Poseidon CRO, Kragujevac

University Medical Centre Ljubljana / Poseidon CRO, Ljubljana

All Listed Sponsors
collaborator

Biofortis Mérieux NutriSciences

OTHER

collaborator

Institut Pasteur de Lille

OTHER

lead

Valbiotis

INDUSTRY

NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes | Biotech Hunter | Biotech Hunter