NCT02005003

Cognitive and Metabolic Effects of a Probiotic Supplement

Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: Male
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

Summary

To examine the cognitive and metabolic effects of a probiotic supplement that is readily and already available for purchase in public drug stores. This study is a double-blinded randomized cross-over placebo-controlled intervention study. Participants will be randomized to receive either the probiotic supplement or the placebo during the first intervention period which will last 2 weeks. This will be followed by a washout period, after which they will proceed to the second intervention period, also lasting 2 weeks and also followed by a washout period.

Conditions

• Dietary Supplements
• Probiotics
• Metabolism
• Food Preferences
• Microbiota

Interventions

Type	Name	Description
BEHAVIORAL	Inhibitory task	Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event
PROCEDURE	Blood samples	Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
BIOLOGICAL	Feces collection	Feces samples will be collected on the morning of each visit, before and after each 2-week intervention period, as well as after each 2-week washout period following each intervention period.
PROCEDURE	Caloric preload	A caloric preload will be given to participants, following which blood will be taken at 65 minutes later (specified in Blood sampling) following the ingestion of the caloric preload.
BEHAVIORAL	Food selection task	Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume
BEHAVIORAL	Memory task	Participants perform short memory tasks on each visit
BEHAVIORAL	Food consumption task	Participants are given a selection of food items to consume on each visit

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-09
• Last updated: 2014-11-18

Locations

1 site across 1 country: Sweden