Ignite Creation Date:
2025-12-17 @ 1:46 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT04491461
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2020-07-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effects of an Herbal Tea on Immune Surveillance and Activation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study uses a randomized double-blinded controlled cross-over study design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-26', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change to natural killer cell numbers in blood circulation', 'timeFrame': 'Changes at 1 and 2 hours after consumption', 'description': 'Flow cytometry evaluation of natural killer cell numbers'}], 'secondaryOutcomes': [{'measure': 'Change to natural killer cell activation status', 'timeFrame': 'Changes at 1 and 2 hours after consumption', 'description': 'Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Immune Response']}, 'descriptionModule': {'briefSummary': 'A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.', 'detailedDescription': "A randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws are performed at 1 and 2 hours after consumption."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults;\n* Age 18-75 years (inclusive);\n* Veins easy to see in both arms (to allow for the multiple blood draws);\n* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;\n\nExclusion Criteria:\n\n* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);\n* Taking anti-inflammatory medications on a daily basis;\n* Currently experiencing intense stressful events/ life changes;\n* Currently in intensive athletic training (such as marathon runners);\n* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;\n* Actively depressed;\n* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);\n* Unwilling to maintain a constant intake of supplements over the duration of the study;\n* Anxiety about having blood drawn;\n* Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;\n* Known food allergies related to ingredients in active test product.'}, 'identificationModule': {'nctId': 'NCT04491461', 'briefTitle': 'Acute Effects of an Herbal Tea on Immune Surveillance and Activation.', 'organization': {'class': 'OTHER', 'fullName': 'Natural Immune Systems Inc'}, 'officialTitle': 'Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.', 'orgStudyIdInfo': {'id': '152-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Herbal tea blend', 'description': '1 cup of herbal tea blend containing Rosehip and other berry extracts.', 'interventionNames': ['Dietary Supplement: Herbal tea blend']}, {'type': 'SHAM_COMPARATOR', 'label': 'Warm water', 'description': '1 cup of warm water.', 'interventionNames': ['Dietary Supplement: Warm water']}], 'interventions': [{'name': 'Herbal tea blend', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 cup of freshly brewed tea from an herbal tea blend.', 'armGroupLabels': ['Herbal tea blend']}, {'name': 'Warm water', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 cup of warm water', 'armGroupLabels': ['Warm water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97601-5904', 'city': 'Klamath Falls', 'state': 'Oregon', 'country': 'United States', 'facility': 'Gitte Jensen', 'geoPoint': {'lat': 42.22487, 'lon': -121.78167}}], 'overallOfficials': [{'name': 'GITTE JENSEN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NIS Labs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Immune Systems Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}