Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT04430803
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2020-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2020-06-07', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TeloTAGGG Telomerase PCR activity in serum', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in DNA methylation', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in blood concentration of advanced glycation end product', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in lipid peroxidation', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in serum FGF21', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in serum TET2', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment)', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}, {'measure': 'Change in maximal oxygen uptake estimated by step-in-place test', 'timeFrame': 'Baseline vs. 6 months post-intervention', 'description': 'Baseline vs. 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '28663789', 'type': 'BACKGROUND', 'citation': 'Xia X, Chen W, McDermott J, Han JJ. Molecular and phenotypic biomarkers of aging. F1000Res. 2017 Jun 9;6:860. doi: 10.12688/f1000research.10692.1. eCollection 2017.'}, {'pmid': '34601077', 'type': 'DERIVED', 'citation': 'Zanini D, Todorovic N, Korovljev D, Stajer V, Ostojic J, Purac J, Kojic D, Vukasinovic E, Djordjievski S, Sopic M, Guzonjic A, Ninic A, Erceg S, Ostojic SM. The effects of 6-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in older adults aged 70 years and over: A randomized controlled pilot trial. Exp Gerontol. 2021 Nov;155:111574. doi: 10.1016/j.exger.2021.111574. Epub 2021 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of six-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in men and women aged 70 years and over.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 70 years\n* Free of acute disorders\n\nExclusion Criteria:\n\n* History of dietary supplement use during the past 4 weeks'}, 'identificationModule': {'nctId': 'NCT04430803', 'acronym': 'H2AGE', 'briefTitle': 'Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Novi Sad, Faculty of Sport and Physical Education'}, 'officialTitle': 'The Effects of Six-month Hydrogen-rich Water Intake on Molecular and Phenotypic Biomarkers of Aging in Men and Women Aged 70 Years and Over: a Randomized-controlled Trial', 'orgStudyIdInfo': {'id': '281048E-HRW/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrogen-rich water', 'description': 'Hydrogen-rich water (Rejuvenation, HRW Natural Health Products Inc.)\n\n* 8 ppm of hydrogen\n* Administered one dose two times per day on an empty stomach in the morning and at the evening', 'interventionNames': ['Dietary Supplement: Hydrogen-rich water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control water', 'description': 'Tap water\n\n* 0 ppm of hydrogen\n* Administered one dose two times per day on an empty stomach in the morning and at the evening', 'interventionNames': ['Other: Control Water']}], 'interventions': [{'name': 'Hydrogen-rich water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A tablet that produces hydrogen dissolved in a glass of water', 'armGroupLabels': ['Hydrogen-rich water']}, {'name': 'Control Water', 'type': 'OTHER', 'description': 'A glass of tap water', 'armGroupLabels': ['Control water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Novi Sad', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'FSPE Applied Bioenergetics Lab', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Novi Sad, Faculty of Sport and Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}