Clinical trial NCT02005003: Cognitive and Metabolic Effects of a Probiotic Supplement
Official title: Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dietary Supplements
Probiotics
Metabolism
Food Preferences
Microbiota
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male
* 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:

* Major illness
* 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)

Primary outcomes:
measure: Memory function
timeFrame: Change in memory function assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
Secondary outcomes:
measure: Glycometabolic regulation
timeFrame: Change in glycometabolic regulation assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
measure: Food preferences
timeFrame: Change in food preferences assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
measure: Inhibitory task
timeFrame: Change in inhibitory task performance assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
measure: Food consumption task
timeFrame: Change in food consumption task assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
measure: Sleep patterns
timeFrame: Change in sleep patterns as assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
measure: Microbiome changes
timeFrame: Microbiome assessed at baseline (week 0), post-intervention 1 (at week 2), pre intervention 2 (week 6), post intervention 2 (week 8) and post-washout intervention 2 (week 12)
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Neuroscience, Uppsala University
Study officials:
affiliation: Department of Neuroscience, Uppsala University
name: Christian Benedict, PhD
role: PRINCIPAL_INVESTIGATOR
References: