Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01089920
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2010-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'D003069', 'term': 'Coffee'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-04', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites', 'timeFrame': 'Measurements done over 24h after ingestion'}], 'secondaryOutcomes': [{'measure': 'Compare Area under the curve (AUC), Maximum plasma concentration (Cmax), Time to reach maximum plasma concentration (Tmax) and half-life (T1/2) of all three doses of coffee for chlorogenic and phenolic acid metabolites', 'timeFrame': 'Measurements done over 12h after ingestion'}, {'measure': 'Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites', 'timeFrame': 'Measurements done over 12h after ingestion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years, male and female\n* Healthy as determined by the medical questionnaire and the medical visit\n* Normal weight: BMI 18 - 25\n* Coffee drinkers with an average consumption of 2-5 cups per day\n* Having given informed consent\n\nExclusion Criteria:\n\n* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer\n* Have had a gastrointestinal surgery, except appendicectomy\n* Difficulty to swallow\n* Have a regular consumption of medication\n* Have taken antibiotic therapy within the last 6 months\n* Alcohol consumption \\> 2 units a day\n* Smokers (more than 5 cigarettes per day)\n* Have given blood within the last 3 weeks\n* Volunteers who cannot be expected to comply with treatment\n* Currently participating or having participated in another clinical trial during the last 3 weeks'}, 'identificationModule': {'nctId': 'NCT01089920', 'briefTitle': 'Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans', 'orgStudyIdInfo': {'id': '09.06.MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose coffee', 'description': 'High dose of polyphenols from soluble coffee', 'interventionNames': ['Other: Coffee']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose coffee', 'description': 'Medium dose of polyphenols from soluble coffee', 'interventionNames': ['Other: Coffee']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose coffee', 'description': 'Low dose of polyphenols from soluble coffee', 'interventionNames': ['Other: Coffee']}, {'type': 'EXPERIMENTAL', 'label': 'High dose green tea', 'description': 'High dose of green tea polyphenols from infusion', 'interventionNames': ['Other: Green tea']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose green tea infusion', 'description': 'Medium dose of green polyphenols from infusion', 'interventionNames': ['Other: Green tea']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose green tea infusion', 'description': 'low dose of polyphenols from an infusion of green tea', 'interventionNames': ['Other: Green tea']}], 'interventions': [{'name': 'Green tea', 'type': 'OTHER', 'description': 'Infusion (tea bags) from commercially available green tea', 'armGroupLabels': ['High dose green tea', 'Low dose green tea infusion', 'Medium dose green tea infusion']}, {'name': 'Coffee', 'type': 'OTHER', 'otherNames': ['Soluble coffee'], 'description': 'Soluble coffee commercially available', 'armGroupLabels': ['High dose coffee', 'Low dose coffee', 'Medium dose coffee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Nestle Research Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Maurice Beaumont, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nestec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}