Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04983420
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073923', 'term': 'Food Intolerance'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'white blood cells', 'timeFrame': 'before beverage intake', 'description': 'white blood cell count'}, {'measure': 'white blood cells', 'timeFrame': '60 minutes after intake', 'description': 'white blood cell count'}, {'measure': 'white blood cells', 'timeFrame': '120 minutes after intake', 'description': 'white blood cell count'}, {'measure': 'inflammatory markers in the blood', 'timeFrame': 'before beverage intake', 'description': 'IL-6, TNF- α, hs-CRP'}, {'measure': 'inflammatory markers in the blood', 'timeFrame': '60 minutes after intake', 'description': 'IL-6, TNF- α, hs-CRP'}, {'measure': 'inflammatory markers in the blood', 'timeFrame': '120 minutes after intake', 'description': 'IL-6, TNF- α, hs-CRP'}, {'measure': 'blood alcohol', 'timeFrame': 'before beverage intake', 'description': 'blood alcohol level'}, {'measure': 'blood alcohol', 'timeFrame': '60 minutes after intake', 'description': 'blood alcohol level'}, {'measure': 'blood alcohol', 'timeFrame': '120 minutes after intake', 'description': 'blood alcohol level'}, {'measure': 'white blood cells', 'timeFrame': 'after 14 days of daily intake', 'description': 'white blood cell count'}, {'measure': 'inflammatory markers in the blood', 'timeFrame': 'after 14 days of daily intake', 'description': 'IL-6, TNF- α, hs-CRP'}, {'measure': 'blood alcohol', 'timeFrame': 'after 14 days of daily intake', 'description': 'blood alcohol level'}, {'measure': 'polyphenol in the urine', 'timeFrame': 'before beverage intake', 'description': 'polyphenol level in the urine'}, {'measure': 'polyphenol in the urine', 'timeFrame': '120 minutes after intake', 'description': 'polyphenol level in the urine'}, {'measure': 'polyphenol in the urine', 'timeFrame': 'after 14 days of daily intake', 'description': 'polyphenol level in the urine'}], 'secondaryOutcomes': [{'measure': 'dietary habit', 'timeFrame': 'before beverage intake and day 12-14 of beverage intake', 'description': '3 day food diary'}, {'measure': 'dietary habit', 'timeFrame': 'day 12-14 of beverage intake', 'description': '3 day food diary'}, {'measure': 'physical activity', 'timeFrame': 'before beverage intake', 'description': 'Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities'}, {'measure': 'physical activity', 'timeFrame': 'day 14 of beverage intake', 'description': 'Global Physical Activity Questionnaire (allows to calculate metabolic equivalents to express the intensity of physical activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Sensitivity']}, 'descriptionModule': {'briefSummary': 'In this research project, the effect of different polyphenol-containing beverages with varying alcohol content of \\< 0.4 vol% on immune function as well as muscular growth factors will be investigated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Age 20 - 60 years\n* Written informed consent\n\nExclusion Criteria:\n\n* severe gastrointestinal disease or known malabsorption\n* use of proton pump inhibitors\n* malignancies\n* rheumatoid diseases\n* metabolic syndrome\n* acute or chronic infections or inflammatory diseases\n* use of medications or supplements to interfere with immune function\n* alcohol and/or drug abuse or addiction\n* dependent relationship with the project manager or his or her employees\n* pregnancy or breastfeeding\n* chronic illness or regular use of medication (except hormonal contraception)\n* smoker'}, 'identificationModule': {'nctId': 'NCT04983420', 'briefTitle': 'Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Effects of Different Polyphenol-containing Beverages on the Immune System and on Muscular Growth Factors - a Pilot Study', 'orgStudyIdInfo': {'id': 'Polyphenol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-alcoholic Pilsner', 'description': '1 L non-alcoholic Pilsner per day for 2 weeks', 'interventionNames': ['Other: non-alcoholic Pilsner']}, {'type': 'EXPERIMENTAL', 'label': 'non-alcoholic wheat beer', 'description': '1 L non-alcoholic wheat beer per day for 2 weeks', 'interventionNames': ['Other: non-alcoholic wheat beer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'apple spritzer', 'description': '1 L apple spritzer per day for 2 weeks', 'interventionNames': ['Other: apple spritzer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'lemonade', 'description': '1 L lemonade per day for 2 weeks', 'interventionNames': ['Other: lemonade']}], 'interventions': [{'name': 'non-alcoholic Pilsner', 'type': 'OTHER', 'description': 'intake of 1 L non-alcoholic Pilsner per day for 2 weeks', 'armGroupLabels': ['non-alcoholic Pilsner']}, {'name': 'non-alcoholic wheat beer', 'type': 'OTHER', 'description': 'intake of 1 L non-alcoholic wheat beer per day for 2 weeks', 'armGroupLabels': ['non-alcoholic wheat beer']}, {'name': 'apple spritzer', 'type': 'OTHER', 'description': 'intake of 1 L apple spritzer per day for 2 weeks', 'armGroupLabels': ['apple spritzer']}, {'name': 'lemonade', 'type': 'OTHER', 'description': 'intake of 1 L lemonade per day for 2 weeks', 'armGroupLabels': ['lemonade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Johannes Scherr, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}