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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02005003
Other study ID # FF8vsPlaceboJC2013
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2013
Last updated November 17, 2014
Start date November 2013
Est. completion date December 2015

Study information

Verified date November 2014
Source Uppsala University
Contact Jonathan Cedernaes, M.D., PhD
Email jonathan.cedernaes@neuro.uu.se
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 28 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Intervention

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
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

Locations

Country Name City State
Sweden Department of Neuroscience, Uppsala University Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory function Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory) 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) No
Secondary Glycometabolic regulation Glucose, insulin and other hormonal values during fasting and 1 hour following a standardized caloric preload 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) No
Secondary Food preferences Will test whether participants food preferences are changed following each intervention, as compared with before each intervention. Test will be written and computer-based. 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) No
Secondary 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. 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) No
Secondary Food consumption task Participants will be offered a food selection and their consumption will be measured. 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) No
Secondary Sleep patterns 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) No
Secondary Microbiome changes Changes in microbiome will be assessed following treatment with either placebo or probiotics; feces will be collected according to standardized criteria. 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) No
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