- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005003
Cognitive and Metabolic Effects of a Probiotic Supplement
November 17, 2014 updated by: Jonathan Cedernaes, Uppsala University
Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
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.
Study Overview
Status
Unknown
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan Cedernaes, M.D., PhD
- Email: jonathan.cedernaes@neuro.uu.se
Study Contact Backup
- Name: Christian Benedict, PhD
- Email: christian.benedict@neuro.uu.se
Study Locations
-
-
-
Uppsala, Sweden, 75324
- Recruiting
- Department of Neuroscience, Uppsala University
-
Contact:
- Jonathan Cedernaes, M.D., PhD
- Email: jonathan.cedernaes@neuro.uu.se
-
Contact:
- Christian Benedict, PhD
- Email: christian.benedict@neuro.uu.se
-
Principal Investigator:
- Christian Benedict, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
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.
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.
Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume
Participants perform short memory tasks on each visit
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.
|
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
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
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.
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.
Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume
Participants perform short memory tasks on each visit
Participants are given a selection of food items to consume on each visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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)
|
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.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Benedict, PhD, Department of Neuroscience, Uppsala University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
December 3, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
November 18, 2014
Last Update Submitted That Met QC Criteria
November 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- FF8vsPlaceboJC2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Probiotics
-
Sanjay Gandhi Postgraduate Institute of Medical...Indian Council of Medical ResearchCompleted
-
Cheng-Hsin General HospitalCompleted
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.Completed
-
Stanford UniversityCompleted
-
Texas Christian UniversityCompleted
-
University of TurkuUniversity of Michigan; The Forsyth InstituteCompleted
-
Chang Gung Memorial HospitalGlac Biotech Co., LtdRecruiting
-
Taipei Medical University Shuang Ho HospitalTaipei Medical University; Delta ElectronicsUnknownProbiotics | Vancomycin-Resistant EnterococciTaiwan
-
Chr HansenUniversity of Copenhagen; Herlev HospitalCompleted
-
Lund UniversityRecruitingProbiotics | Healthy Diet | Gastrointestinal MicrobiomeSweden
Clinical Trials on Inhibitory task
-
Uppsala UniversityCompletedSleep | Sleep DeprivationSweden
-
King's College LondonUniversity of ExeterCompleted
-
Assiut UniversityNot yet recruitingSystemic Lupus Erythematosus
-
Boston Children's HospitalNeuroscouting, L.L.C.CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Drexel UniversityDrexel Coulter Translational Research Partnership ProgramCompletedBinge Eating | Inhibition (Psychology)United States
-
Brigham Young UniversityCompletedOverweight and ObesityUnited States
-
Na LiuNot yet recruiting
-
University of Nevada, RenoNot yet recruitingHealthy AgingUnited States
-
University of Colorado, DenverCompletedAnxiety DisordersUnited States
-
University of BernCompletedMajor Depressive Disorder | Schizophrenia and Related Disorders | Psychomotor Retardation | Psychomotor SlowingSwitzerland