Cognitive and Metabolic Effects of a Probiotic Supplement

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02005003
• Other study ID #: FF8vsPlaceboJC2013
• 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

Related Conditions & MeSH terms

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

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