The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass
The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass
NCT ID: NCT01978691 Phase: PHASE2 Status: COMPLETED Enrollment: 225 Completion: 2015-05
Conditions
Obesity, Hyperglycemia, Insulin Resistance
Interventions
Bifidobacterium animalis ssp. lactis 420, Polydextrose, Placebo
Summary
Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The supplement is ingested once per day for the duration of six months, and participants will attend a follow-up visit one month after the end of the intervention. The study will enroll 232 participants (58 per study arm) in four research centers in southern Finland.
Primary Outcome
Difference in body fat mass from baseline to end-of-treatment (6 months)