Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-20 @ 1:06 AM
Study NCT ID:
NCT06828159
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Wild Blueberries and Joint Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum biomarkers of joint function', 'timeFrame': '12 weeks', 'description': 'Serum biomarkers of inflammation and cartilage degradation will be measured in the wild blueberry and placebo groups and compared for outcomes. Pain scores will also be measured using self-reported questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiome', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gut -Microbiota', 'Inflammation Biomarkers', 'Pain Assessment', 'Joint Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. Each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with documented multi-joint/knee arthritis\n\nExclusion Criteria:\n\n* inability to give informed consent\n* pregnancy or lactation\n* planned knee replacement surgery\n* allergy or contraindication to berries\n* recent trauma of the knee responsible of the symptomatic knee\n* intra-articular injection in the target knee/hip in the last 3 months\n* oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline\n* use of berry extracts in the last 3 months\n* special diets\n* cancer treatment\n* bone diseases'}, 'identificationModule': {'nctId': 'NCT06828159', 'briefTitle': 'Dietary Wild Blueberries and Joint Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Effects of Dietary Wild Blueberries on Gut Health and Inflammation and Joint Pain', 'orgStudyIdInfo': {'id': 'OMRF WB01'}, 'secondaryIdInfos': [{'id': 'WBANA01', 'type': 'OTHER_GRANT', 'domain': 'WBANA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wild blueberries', 'description': '25g freeze-dried wild blueberries daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Wild blueberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo powder free from polyphenols matched for calories', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Wild blueberry', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Freeze-dried wild blueberry powder 25g/day', 'armGroupLabels': ['Wild blueberries']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo powder matched for calories and no polyphenols', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Judy Goodman', 'role': 'CONTACT', 'email': 'judy-goodman@omrf.org', 'phone': '405- 271-3007'}], 'facility': 'OMRF', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'centralContacts': [{'name': 'Arpita Basu', 'role': 'CONTACT', 'email': 'arpita.basu@unlv.edu', 'phone': '702-895-4576'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oklahoma Medical Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arpita Basu', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}