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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhibitory task | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Memory function | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycometabolic regulation | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Cedernaes, M.D., PhD | Contact | jonathan.cedernaes@neuro.uu.se | ||
| Christian Benedict, PhD | Contact | christian.benedict@neuro.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Christian Benedict, PhD | Department of Neuroscience, Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroscience, Uppsala University | Recruiting | Uppsala | 75324 | Sweden |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood samples | Procedure | Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit |
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| Feces collection | Biological | 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. |
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| Caloric preload | Procedure | 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. |
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| Food selection task | Behavioral | Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume |
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| Memory task | Behavioral | Participants perform short memory tasks on each visit |
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| Food consumption task | Behavioral | Participants are given a selection of food items to consume on each visit |
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| 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. |
| 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. | 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. | 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 | 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. | 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) |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |