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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

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date November 18, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Memory function [ Time Frame: Change in memory function assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
Memory test to examine the influence of probiotic supplement compared with placebo on memory function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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
  • 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.
  • 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.
  • 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.
  • 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) ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Glycometabolic regulation [ Time Frame: Change in glycometabolic regulation assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
    Glucose and insulin values during fasting and following an oral glucose tolerance test (OGTT)
  • Food preferences [ Time Frame: Change in food preferences assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
    Will test whether participants food preferences are changed following each intervention, as compared with before each intervention. Test will be written and computer-based.
  • Inhibitory task [ Time Frame: Change in inhibitory task performance assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
    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
  • Food consumption task [ Time Frame: Change in food consumption task assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
    2 hours after intake of an oral glucose tolerance test, participants will be offered a food selection and their consumption will be measured.
  • Oral glucose tolerance test [ Time Frame: Change in oral glucose tolerance assessed at baseline (week 0), post-intervention 1 (at week 4), pre intervention 2 (week 8), post intervention 2 (week 12) and post-washout intervention 2 (week 16) ]
    75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90 and 120 minutes following the ingestion of the glucose solution.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive and Metabolic Effects of a Probiotic Supplement
Official Title  ICMJE Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Dietary Supplements
  • Probiotics
  • Metabolism
  • Food Preferences
  • Microbiota
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Inhibitory task
    • Procedure: Blood samples
    • Biological: Feces collection
    • Procedure: Caloric preload
    • Behavioral: Food selection task
    • Behavioral: Memory task
    • Behavioral: Food consumption task
  • 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.
    Interventions:
    • Behavioral: Inhibitory task
    • Procedure: Blood samples
    • Biological: Feces collection
    • Procedure: Caloric preload
    • Behavioral: Food selection task
    • Behavioral: Memory task
    • Behavioral: Food consumption task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 28 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005003
Other Study ID Numbers  ICMJE FF8vsPlaceboJC2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Cedernaes, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Benedict, PhD Department of Neuroscience, Uppsala University
PRS Account Uppsala University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP