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Cognitive and Metabolic Effects of a Probiotic Supplement

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

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

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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

Resource links provided by the National Library of Medicine


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




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.



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005003


Contacts
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Contact: Jonathan Cedernaes, M.D., PhD jonathan.cedernaes@neuro.uu.se
Contact: Christian Benedict, PhD christian.benedict@neuro.uu.se

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

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