Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-01 @ 11:38 AM
Study NCT ID:
NCT02005003
Status:
UNKNOWN
Last Update Posted:
2014-11-18
First Post:
2013-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive and Metabolic Effects of a Probiotic Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory function', 'timeFrame': '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)', 'description': 'Memory test to examine the influence of probiotic supplement compared with placebo on memory function (declarative and working memory)'}], 'secondaryOutcomes': [{'measure': 'Glycometabolic regulation', 'timeFrame': '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)', 'description': 'Glucose, insulin and other hormonal values during fasting and 1 hour following a standardized caloric preload'}, {'measure': 'Food preferences', 'timeFrame': '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)', 'description': 'Will test whether participants food preferences are changed following each intervention, as compared with before each intervention. Test will be written and computer-based.'}, {'measure': 'Inhibitory task', 'timeFrame': '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)', 'description': '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': 'Food consumption task', 'timeFrame': '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)', 'description': 'Participants will be offered a food selection and their consumption will be measured.'}, {'measure': 'Sleep patterns', 'timeFrame': '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)'}, {'measure': 'Microbiome changes', 'timeFrame': '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)', 'description': 'Changes in microbiome will be assessed following treatment with either placebo or probiotics; feces will be collected according to standardized criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dietary Supplements', 'Probiotics', 'Metabolism', 'Food Preferences', 'Microbiota']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 18-28y\n* Healthy (self-reported) and not on medication\n* Non-smoking\n* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)\n* Regular meal patterns with daily breakfast\n\nExclusion Criteria:\n\n* Major illness\n* Taking any serious medications\n* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)\n* Any dietary issues with the food items provided\n* Current or history of endocrine, neurological or psychiatric disorders\n* Shift work in the preceding three months or for a long duration\n* Time travel over a significant number of time zones in the preceding two months\n* Too much weight gain or weight loss in the preceding three months\n* Excessive intake of fermented dairy products\n* Intake of probiotics\n* Recent antibiotic treatment (last 6 months)\n* Recent intake of certain dietary supplements\n* Excessive caffeine (\\>5 cups daily) or alcohol intake (\\>2 alcohol units daily)'}, 'identificationModule': {'nctId': 'NCT02005003', 'briefTitle': 'Cognitive and Metabolic Effects of a Probiotic Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Placebo-controlled Randomized Trial of Cognitive and Metabolic Effects of a Probiotic Supplement', 'orgStudyIdInfo': {'id': 'FF8vsPlaceboJC2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': '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.', 'interventionNames': ['Behavioral: Inhibitory task', 'Procedure: Blood samples', 'Biological: Feces collection', 'Procedure: Caloric preload', 'Behavioral: Food selection task', 'Behavioral: Memory task', 'Behavioral: Food consumption task']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Behavioral: Inhibitory task', 'Procedure: Blood samples', 'Biological: Feces collection', 'Procedure: Caloric preload', 'Behavioral: Food selection task', 'Behavioral: Memory task', 'Behavioral: Food consumption task']}], 'interventions': [{'name': 'Inhibitory task', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Blood samples', 'type': 'PROCEDURE', 'description': 'Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Feces collection', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Caloric preload', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Food selection task', 'type': 'BEHAVIORAL', 'description': 'Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Memory task', 'type': 'BEHAVIORAL', 'description': 'Participants perform short memory tasks on each visit', 'armGroupLabels': ['Placebo', 'Probiotic']}, {'name': 'Food consumption task', 'type': 'BEHAVIORAL', 'description': 'Participants are given a selection of food items to consume on each visit', 'armGroupLabels': ['Placebo', 'Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75324', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jonathan Cedernaes, M.D., PhD', 'role': 'CONTACT', 'email': 'jonathan.cedernaes@neuro.uu.se'}, {'name': 'Christian Benedict, PhD', 'role': 'CONTACT', 'email': 'christian.benedict@neuro.uu.se'}, {'name': 'Christian Benedict, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neuroscience, Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Jonathan Cedernaes, M.D., PhD', 'role': 'CONTACT', 'email': 'jonathan.cedernaes@neuro.uu.se'}, {'name': 'Christian Benedict, PhD', 'role': 'CONTACT', 'email': 'christian.benedict@neuro.uu.se'}], 'overallOfficials': [{'name': 'Christian Benedict, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neuroscience, Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, PhD', 'investigatorFullName': 'Jonathan Cedernaes', 'investigatorAffiliation': 'Uppsala University'}}}}