Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT07269704
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007656', 'term': 'Ketoglutaric Acids'}], 'ancestors': [{'id': 'D005977', 'term': 'Glutarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007651', 'term': 'Keto Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in aqueous humor aKG concentration', 'timeFrame': 'Baseline and post-supplementation, approximately 28 days', 'description': 'To evaluate the mean difference in fold-change in aKG levels from baseline to post-supplementation in eye fluid'}], 'secondaryOutcomes': [{'measure': 'Mean fold-change in metabolic and retinal pathways', 'timeFrame': 'Baseline and post-supplementation, approximately 28 days', 'description': 'To calculate mean fold-change in retinal metabolic and protein pathways from baseline to post-supplementation in eye fluid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Diseases']}, 'referencesModule': {'references': [{'pmid': '17896582', 'type': 'BACKGROUND', 'citation': 'Filip RS, Pierzynowski SG, Lindegard B, Wernerman J, Haratym-Maj A, Podgurniak M. Alpha-ketoglutarate decreases serum levels of C-terminal cross-linking telopeptide of type I collagen (CTX) in postmenopausal women with osteopenia: six-month study. Int J Vitam Nutr Res. 2007 Mar;77(2):89-97. doi: 10.1024/0300-9831.77.2.89.'}, {'pmid': '8893139', 'type': 'BACKGROUND', 'citation': 'Riedel E, Nundel M, Hampl H. alpha-Ketoglutarate application in hemodialysis patients improves amino acid metabolism. Nephron. 1996;74(2):261-5. doi: 10.1159/000189319.'}, {'pmid': '32028070', 'type': 'BACKGROUND', 'citation': 'Wert KJ, Velez G, Kanchustambham VL, Shankar V, Evans LP, Sengillo JD, Zare RN, Bassuk AG, Tsang SH, Mahajan VB. Metabolite therapy guided by liquid biopsy proteomics delays retinal neurodegeneration. EBioMedicine. 2020 Feb;52:102636. doi: 10.1016/j.ebiom.2020.102636. Epub 2020 Feb 3.'}, {'pmid': '33315052', 'type': 'BACKGROUND', 'citation': 'Hou XW, Wang Y, Pan CW. Metabolomics in Age-Related Macular Degeneration: A Systematic Review. Invest Ophthalmol Vis Sci. 2020 Dec 1;61(14):13. doi: 10.1167/iovs.61.14.13.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the study are as follows:\n\n1. Determine how the eye absorbs supplements taken orally.\n2. Look for specific signs in the proteins and substances in the eyes of people with eye diseases who are also taking nutritional supplements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give written informed consent\n2. Able to attend all study visits and complete the study procedures\n3. Women of child-bearing potential must have a negative pregnancy test within 2 weeks before cataract surgery. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilized (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n1. Diabetes and/or thyroid, liver, kidney, bowel, and metabolic diseases or disorders\n2. History of supplement allergy or planned major surgery\n3. Received any other clinical trial drug within 4 months\n4. Calculated creatinine clearance of less than 30 ml/min'}, 'identificationModule': {'nctId': 'NCT07269704', 'acronym': 'OAK AGE', 'briefTitle': 'Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease: An Open Label, Single Arm Study to Evaluate the Effect of Alpha-ketoglutarate Administered Orally in Patients With Age-related Ocular Diseases (Metabolic Eye Therapy)', 'orgStudyIdInfo': {'id': '68157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium alpha-ketoglutarate (Ca-aKG)', 'description': 'At the first and second cataract surgery of the participant, a small amount of tissue (eye fluid \\~0.1 ml or 1-2 drops) is removed for analysis. Beginning one week (7 days) prior to their second cataract extraction surgery, the patient takes an oral nutritional supplement (calcium alpha-ketoglutarate) 2 times a day.', 'interventionNames': ['Drug: Calcium alpha-ketoglutarate']}], 'interventions': [{'name': 'Calcium alpha-ketoglutarate', 'type': 'DRUG', 'otherNames': ['Prohealth Longevity'], 'description': 'Participants took 2 g/day of calcium alpha-ketoglutarate orally, twice daily, for 7 days.', 'armGroupLabels': ['Calcium alpha-ketoglutarate (Ca-aKG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Vinit Mahajan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The data will be made available upon study registration with CTgov, and will remain available for at least 5 years.', 'ipdSharing': 'YES', 'description': 'Age, sex, BMI, Medical history, ocular history', 'accessCriteria': 'Results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Vinit Mahajan', 'investigatorAffiliation': 'Stanford University'}}}}