Dietary SupplementsNCT02005003
Cognitive and Metabolic Effects of a Probiotic Supplement
A study testing Inhibitory task, Blood samples and Feces collection in people with Dietary Supplements and Probiotics, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements, Probiotics, Metabolism
- What is being tested?
- Inhibitory task, Blood samples and Feces collection
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Jonathan Cedernaes, M.D., PhD contact
Christian Benedict, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Neuroscience, Uppsala University
Uppsala, 75324
Jonathan Cedernaes, M.D., PhD, jonathan.cedernaes@neuro.uu.se
Christian Benedict, PhD, christian.benedict@neuro.uu.se
About this study
Official title: 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.
- Conditions
- Dietary Supplements, Probiotics, Metabolism, Food Preferences, Microbiota
- Being tested
- Inhibitory task, Blood samples, Feces collection, Caloric preload, Food selection task
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibitory taskBehavioural
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
Blood samplesProcedure or surgery
Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
Feces collectionBiological
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.
Caloric preloadProcedure or surgery
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.
Food selection taskBehavioural
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 taskBehavioural
Participants perform short memory tasks on each visit
Food consumption taskBehavioural
Participants are given a selection of food items to consume on each visit
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | 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. Receives: Behavioral: Inhibitory task; Procedure: Blood samples; Biological: Feces collection; Procedure: Caloric preload; Behavioral: Food selection task; Behavioral: Memory task; Behavioral: Food consumption task |
| Placebo | Placebo comparator | 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. Receives: Behavioral: Inhibitory task; Procedure: Blood samples; Biological: Feces collection; Procedure: Caloric preload; Behavioral: Food selection task; Behavioral: Memory task; Behavioral: Food consumption task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory function
Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory)
Measured: 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 outcomes (6)
Glycometabolic regulation
Glucose, insulin and other hormonal values during fasting and 1 hour following a standardized caloric preload
Measured: 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
Will test whether participants food preferences are changed following each intervention, as compared with before each intervention. Test will be written and computer-based.
Measured: 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
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.
Measured: 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
Participants will be offered a food selection and their consumption will be measured.
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
Measured: 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
Changes in microbiome will be assessed following treatment with either placebo or probiotics; feces will be collected according to standardized criteria.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Cedernaes, Uppsala University
- Investigators
- Christian Benedict, PhD, Principal investigator, Department of Neuroscience, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005003
- Sponsor's protocol ID
- FF8vsPlaceboJC2013
- Status last verified
- Nov 2014
- First submitted
- 27 Nov 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement
- ClinicalTrials.gov ID
- NCT02005003
- Acronym / sponsor ID
- FF8vsPlaceboJC2013
- Conditions
- Dietary Supplements, Probiotics, Metabolism, Food Preferences, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Behavioral: Inhibitory task, Procedure: Blood samples, Biological: Feces collection, Procedure: Caloric preload, Behavioral: Food selection task, Behavioral: Memory task, Behavioral: Food consumption taskProbiotic 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. |
| Placebo | Placebo comparator | Behavioral: Inhibitory task, Procedure: Blood samples, Biological: Feces collection, Procedure: Caloric preload, Behavioral: Food selection task, Behavioral: Memory task, Behavioral: Food consumption taskPlacebo 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhibitory taskParticipants 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 | Behavioural | Placebo, Probiotic |
| Blood samplesHormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit | Procedure or surgery | Placebo, Probiotic |
| Feces collectionFeces 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. | Biological | Placebo, Probiotic |
| Caloric preloadA 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. | Procedure or surgery | Placebo, Probiotic |
| Food selection taskParticipants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume | Behavioural | Placebo, Probiotic |
| Memory taskParticipants perform short memory tasks on each visit | Behavioural | Placebo, Probiotic |
| Food consumption taskParticipants are given a selection of food items to consume on each visit | Behavioural | Placebo, Probiotic |
Primary outcome
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)
6 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Cedernaes, M.D., PhD contact
Christian Benedict, PhD contact
Christian Benedict, PhD principal investigator
Department of Neuroscience, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibitory task, Blood samples and Feces collection in people with Dietary Supplements and Probiotics, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Cedernaes, M.D., PhD (jonathan.cedernaes@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.