Cognitive and Metabolic Effects of a Probiotic Supplement
NCT ID: NCT02005003
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2013-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Probiotic
Probiotic pills given for 2 weeks, during one of the interventions that the participants is either randomized to as the first or second intervention period. At day 0 and following each intervention period (at week 2 and week 6), participants will be tested using Inhibitory task, Blood samples, Feces collection, Caloric preload, Food selection task, Memory task and Food consumption task.
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
Blood samples
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
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.
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.
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
Memory task
Participants perform short memory tasks on each visit
Food consumption task
Participants are given a selection of food items to consume on each visit
Placebo
Placebo pills given for 2 weeks, during one of the interventions that the participants is either randomized to as the first or second intervention period. At day 0 and following each intervention period (at week 2 and week 6), participants will be tested using Inhibitory task, Blood samples, Feces collection, Caloric preload, Food selection task, Memory task and Food consumption task.
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
Blood samples
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
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.
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.
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
Memory task
Participants perform short memory tasks on each visit
Food consumption task
Participants are given a selection of food items to consume on each visit
Interventions
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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
Blood samples
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
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.
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.
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
Memory task
Participants perform short memory tasks on each visit
Food consumption task
Participants are given a selection of food items to consume on each visit
Eligibility Criteria
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Inclusion Criteria
* Age 18-28y
* Healthy (self-reported) and not on medication
* Non-smoking
* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)
* Regular meal patterns with daily breakfast
Exclusion Criteria
* Taking any serious medications
* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
* Any dietary issues with the food items provided
* Current or history of endocrine, neurological or psychiatric disorders
* Shift work in the preceding three months or for a long duration
* Time travel over a significant number of time zones in the preceding two months
* Too much weight gain or weight loss in the preceding three months
* Excessive intake of fermented dairy products
* Intake of probiotics
* Recent antibiotic treatment (last 6 months)
* Recent intake of certain dietary supplements
* Excessive caffeine (\>5 cups daily) or alcohol intake (\>2 alcohol units daily)
18 Years
28 Years
MALE
Yes
Sponsors
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Uppsala University
OTHER
Responsible Party
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Jonathan Cedernaes
Medical doctor, PhD
Principal Investigators
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Christian Benedict, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neuroscience, Uppsala University
Locations
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Department of Neuroscience, Uppsala University
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FF8vsPlaceboJC2013
Identifier Type: -
Identifier Source: org_study_id