Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT02917616
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2016-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Drinking-Water pH on the Human Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Shannon's alpha diversity index", 'timeFrame': 'Intervention day 14', 'description': 'Diversity of the gut microbial community'}], 'secondaryOutcomes': [{'measure': "Simpsons' reciprocal diversity index", 'timeFrame': 'Intervention day 14', 'description': 'Diversity of the gut microbial community'}, {'measure': 'Observed richness', 'timeFrame': 'Intervention day 14', 'description': 'Observed number of operational taxonomic units'}, {'measure': 'Estimated richness', 'timeFrame': 'Intervention day 14', 'description': 'Number of operational taxonomic units estimated using the Chao1 method'}, {'measure': 'Unweighted UniFrac', 'timeFrame': 'Intervention day 14', 'description': 'Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances'}, {'measure': 'Weighted UniFrac', 'timeFrame': 'Intervention day 14', 'description': 'Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances'}, {'measure': 'Bray-Curtis', 'timeFrame': 'Intervention day 14', 'description': 'Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances'}, {'measure': 'Operational taxonomic unit', 'timeFrame': 'Intervention day 14', 'description': 'Relative abundance of individual operational taxonomic units'}, {'measure': 'Bacterial genera', 'timeFrame': 'Intervention day 14', 'description': 'Relative abundance of operational taxonomic units aggregated at genus level'}, {'measure': 'Plasma glucose; global', 'timeFrame': 'Intervention day 14', 'description': 'Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test'}, {'measure': 'Serum insulin; global', 'timeFrame': 'Intervention day 14', 'description': 'Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test'}, {'measure': 'Serum insulin; individual timepoints', 'timeFrame': 'Intervention day 14', 'description': 'Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test'}, {'measure': 'Plasma glucose; individual timepoints', 'timeFrame': 'Intervention day 14', 'description': 'Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test'}, {'measure': 'High sensitivity C-reactive protein', 'timeFrame': 'Intervention day 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '30413727', 'type': 'DERIVED', 'citation': 'Hansen TH, Thomassen MT, Madsen ML, Kern T, Bak EG, Kashani A, Allin KH, Hansen T, Pedersen O. The effect of drinking water pH on the human gut microbiota and glucose regulation: results of a randomized controlled cross-over intervention. Sci Rep. 2018 Nov 9;8(1):16626. doi: 10.1038/s41598-018-34761-5.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Non-smoker\n* Age 18 - 35 years\n* Weight stabile for at least 2 months\n* BMI between 20.0 - 27.0 kg/m\\^2\n\nExclusion Criteria:\n\n* Habitual consumption of caloric or artificially sweetened beverages in excess of 1L/week\n* Habitual average consumption of alcohol in excess of 7 drinks/week\n* Antibiotic treatment within two months of inclusion\n* Chronic or acute illness\n* Previous abdominal surgery'}, 'identificationModule': {'nctId': 'NCT02917616', 'briefTitle': 'The Effect of Drinking-Water pH on the Human Gut Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'The Novo Nordisk Foundation Center for Basic Metabolic Research'}, 'orgStudyIdInfo': {'id': 'H-15011825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alkaline water', 'description': 'Two liters (minimum) daily of alkaline drinking-water (pH=9) for 14 days', 'interventionNames': ['Other: Alkaline drinking-water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neutral Water', 'description': 'Two liters (minimum) daily of neutral drinking-water (pH=7) for 14 days', 'interventionNames': ['Other: Neutral drinking-water']}], 'interventions': [{'name': 'Alkaline drinking-water', 'type': 'OTHER', 'armGroupLabels': ['Alkaline water']}, {'name': 'Neutral drinking-water', 'type': 'OTHER', 'armGroupLabels': ['Neutral Water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Oluf Pedersen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Novo Nordisk Foundation Center for Basic Metabolic Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymised datasets generated during the current study are available from the corresponding author on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Novo Nordisk Foundation Center for Basic Metabolic Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}