Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-01-01 @ 5:40 PM
Study NCT ID:
NCT04556032
Status:
TERMINATED
Last Update Posted:
2020-11-04
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery', 'timeFrame': 'Baseline to Week 16'}], 'secondaryOutcomes': [{'measure': 'Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery', 'timeFrame': 'Baseline to weeks 4 and 8'}, {'measure': 'Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery', 'timeFrame': 'Baseline to weeks 4, 8 and 16'}, {'measure': 'Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)', 'timeFrame': 'Baseline to weeks 4, 8 and 16'}, {'measure': 'Changes in mood based on Profile of Mood States Questionnaire (POMS)', 'timeFrame': 'Baseline to weeks 4, 8 and 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.', 'detailedDescription': 'This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals 55-79 years of age.\n* Body mass index (BMI) 18.50-34.99 kg/m2\n* Non-smoker defined as no smoking for at least 6 months.\n* Willing to limit alcohol and caffeine consumption\n* Generally, in good health based on medical history and laboratory assessments\n* Agree to avoid consumption of mushrooms and excluded medications/supplements for the duration of the study\n* Willing to commit to all study procedures\n\nExclusion Criteria:\n\n* Consumption of mushrooms more than once per week\n* History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease.\n* Scores ≥17 on the Beck Depression Inventory\n* History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder\n* History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years\n* Use of any product containing marijuana (THC) and/or cannabidiol (CBD) including oral consumption, inhalation, \\& other\n* Any intolerance to any components of the study products\n* Exposure to any non-registered drug product within the past 30 days\n* History of drug or alcohol abuse\n* Considered unfit for any reason as determined by the principal investigator"}, 'identificationModule': {'nctId': 'NCT04556032', 'briefTitle': 'Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women', 'organization': {'class': 'OTHER', 'fullName': 'Midwest Center for Metabolic and Cardiovascular Research'}, 'officialTitle': 'A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women', 'orgStudyIdInfo': {'id': 'MB-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-Ergothioneine 10 mg/d', 'description': 'Participants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks.', 'interventionNames': ['Dietary Supplement: L-Ergothioneine 10 mg/d']}, {'type': 'EXPERIMENTAL', 'label': 'L-Ergothioneine 25 mg/d', 'description': 'Participants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks.', 'interventionNames': ['Dietary Supplement: L-Ergothioneine 25 mg/d']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally once daily for 16 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'L-Ergothioneine 10 mg/d', 'type': 'DIETARY_SUPPLEMENT', 'description': 'L-Ergothioneine 10 mg/d', 'armGroupLabels': ['L-Ergothioneine 10 mg/d']}, {'name': 'L-Ergothioneine 25 mg/d', 'type': 'DIETARY_SUPPLEMENT', 'description': 'L-Ergothioneine 25 mg/d', 'armGroupLabels': ['L-Ergothioneine 25 mg/d']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0 mg/d L-Ergothioneine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Center for Metabolic and Cardiovascular Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue California Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}