Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease

NCT ID: NCT07269704

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2025-06-10

Brief Summary

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The aims of the study are as follows:

1. Determine how the eye absorbs supplements taken orally.
2. Look for specific signs in the proteins and substances in the eyes of people with eye diseases who are also taking nutritional supplements.

Detailed Description

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Conditions

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Eye Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Calcium alpha-ketoglutarate (Ca-aKG)

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.

Group Type EXPERIMENTAL

Calcium alpha-ketoglutarate

Intervention Type DRUG

Participants took 2 g/day of calcium alpha-ketoglutarate orally, twice daily, for 7 days.

Interventions

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Calcium alpha-ketoglutarate

Participants took 2 g/day of calcium alpha-ketoglutarate orally, twice daily, for 7 days.

Intervention Type DRUG

Other Intervention Names

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Prohealth Longevity

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to give written informed consent
2. Able to attend all study visits and complete the study procedures
3. 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).

Exclusion Criteria

1. Diabetes and/or thyroid, liver, kidney, bowel, and metabolic diseases or disorders
2. History of supplement allergy or planned major surgery
3. Received any other clinical trial drug within 4 months
4. Calculated creatinine clearance of less than 30 ml/min
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Vinit Mahajan

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinit Mahajan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17896582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8893139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32028070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33315052 (View on PubMed)

Other Identifiers

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68157

Identifier Type: -

Identifier Source: org_study_id

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