Cognitive and Metabolic Effects of a Probiotic Supplement

• ClinicalTrials.gov Identifier: NCT02005003
• Recruitment Status: Unknown
• First Posted: December 9, 2013
• Last Update Posted: November 18, 2014
• Sponsor: Uppsala University
• Information provided by (Responsible Party): Jonathan Cedernaes, Uppsala University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dietary Supplements; Probiotics; Metabolism; Food Preferences; Microbiota	Behavioral: Inhibitory task; Procedure: Blood samples; Biological: Feces collection; Procedure: Caloric preload; Behavioral: Food selection task; Behavioral: Memory task; Behavioral: Food consumption task	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
• Study Start Date: November 2013
• Estimated Primary Completion Date: December 2015
• Estimated Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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
Placebo Comparator: 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.	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

Outcome Measures

Primary Outcome Measures :

1. Memory function [ Time Frame: 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) ]
   Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory)

Secondary Outcome Measures :

1. Glycometabolic regulation [ Time Frame: 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) ]
   Glucose, insulin and other hormonal values during fasting and 1 hour following a standardized caloric preload
2. Food preferences [ Time Frame: 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) ]
   Will test whether participants food preferences are changed following each intervention, as compared with before each intervention. Test will be written and computer-based.
3. Inhibitory task [ Time Frame: 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) ]
   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.
4. Food consumption task [ Time Frame: 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) ]
   Participants will be offered a food selection and their consumption will be measured.
5. Sleep patterns [ Time Frame: 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) ]
6. Microbiome changes [ Time Frame: 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) ]
   Changes in microbiome will be assessed following treatment with either placebo or probiotics; feces will be collected according to standardized criteria.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 28 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Contacts

Contact: Jonathan Cedernaes, M.D., PhD; jonathan.cedernaes@neuro.uu.se

Contact: Christian Benedict, PhD; christian.benedict@neuro.uu.se

Locations

Sweden

Department of Neuroscience, Uppsala University; Recruiting

Uppsala, Sweden, 75324

Contact: Jonathan Cedernaes, M.D., PhD jonathan.cedernaes@neuro.uu.se

Contact: Christian Benedict, PhD christian.benedict@neuro.uu.se

Principal Investigator: Christian Benedict, PhD

Sponsors and Collaborators

Uppsala University

Investigators

• Principal Investigator: Christian Benedict, PhD; Department of Neuroscience, Uppsala University

More Information

• Responsible Party: Jonathan Cedernaes, Medical doctor, PhD, Uppsala University
• ClinicalTrials.gov Identifier: NCT02005003
• Other Study ID Numbers: FF8vsPlaceboJC2013
• First Posted: December 9, 2013
• Last Update Posted: November 18, 2014
• Last Verified: November 2014