Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT05534893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Blueberries on Immunity and Response to Flu Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'his will be a parallel, free-living, randomized controlled trial, where 52 overweight men and postmenopausal women will be randomized to receive either the freeze dried blueberries or a placebo powder'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in lymphocyte populations', 'timeFrame': 'baseline to 8 weeks', 'description': 'Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells'}, {'measure': 'changes in cytokine production', 'timeFrame': 'baseline to 8 weeks', 'description': 'PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA'}, {'measure': 'changes in natural killer (NK) cell activity', 'timeFrame': 'baseline to 8 weeks', 'description': 'The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a'}, {'measure': 'changes in serum inflammatory cytokine concentration', 'timeFrame': 'baseline to 8 weeks', 'description': 'Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)'}, {'measure': 'changes in complete blood count (CBC)', 'timeFrame': 'baseline to 8 weeks', 'description': 'changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility'}], 'secondaryOutcomes': [{'measure': 'changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain', 'timeFrame': 'week 8 to week 12', 'description': 'Neutralizing antibody titers in the serum against the hemagglutinin and neuraminidase of the vaccine strain will be measured using the standard commercial ELISA kits'}, {'measure': 'changes in the viral load in response to vaccination', 'timeFrame': 'week 8 to week 12', 'description': 'viral load in blood will be measured using a quantitative polymerase chain reaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Almonds', 'Immunity', 'Inflammation'], 'conditions': ['Immune Response', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight older men and postmenopausal women', 'detailedDescription': 'A free-living parallel, single-blind, RCT will be utilized. There will be two phases: Phase 1 - to examine the effects of Blueberries on plasma markers of immune strength, and Phase 2 - to assess the response to influenza vaccine following blueberry intake. Subjects will either consume their usual diet with (Blueberry group) or a placebo(control group) blueberries for 8 weeks, receive the influenza vaccination, and continue the intervention for another 4 weeks. The test food will be freeze-dried powder (FDP) (\\~ to 1 cup fresh blueberries) per day with the usual diet. The control will be the placebo powder with some guidelines to restrict all berries and other polyphenol-rich foods. The entire study will last 12 weeks. Participants will attend a baseline clinic at which time they will be randomized to one of the two groups. Clinic visits will occur at baseline, weeks 4 and 8 before, and week 4 after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older men and post-menopausal women aged 50-70 year 2. Have BMI of 25-32 3. Able to commute to Loma Linda University 3. Not taking medication or supplements that affect immunity 4. Agree to get vaccinated for Flu\n\nExclusion Criteria:\n\n1. Intolerance or allergy to Blueberries\n2. Regular intake of Blueberries and other berried (\\>2 ounces/week)\n3. Immune system insufficiency or disease\n4. Using immune boosting supplements\n5. Exposure to antibiotics and corticoids immediately prior to study\n6. Uncontrolled chronic diseases and relevant psychiatric illness, including major depression\n7. Flu vaccination less than 10 months ago from the start of the study'}, 'identificationModule': {'nctId': 'NCT05534893', 'acronym': 'Blueberry', 'briefTitle': 'Effect of Blueberries on Immunity and Response to Flu Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Immune Benefits of Blueberry Consumption and Response to Influenza Vaccination in Overweight Older Men and Postmenopausal Women: A Randomized Trial', 'orgStudyIdInfo': {'id': '5220098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blueberry powder group', 'description': 'Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder', 'interventionNames': ['Dietary Supplement: Blueberry powder group', 'Dietary Supplement: Placebo powder group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo powder group', 'description': 'Participants in the placebo group will receive an isocaloric placebo powder.', 'interventionNames': ['Dietary Supplement: Blueberry powder group', 'Dietary Supplement: Placebo powder group']}], 'interventions': [{'name': 'Blueberry powder group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder', 'armGroupLabels': ['Blueberry powder group', 'Placebo powder group']}, {'name': 'Placebo powder group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in the placebo powder group will receive an isocaloric placebo powder', 'armGroupLabels': ['Blueberry powder group', 'Placebo powder group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University School of Public Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Joan Sabate, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}, {'name': 'Sujatha Rajaram, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Highbush Blueberry Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}