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

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)

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07269704

Acronym

OAK AGE

Enrollment

Registered

2025-12-08

Start date

2023-08-15

Completion date

2025-06-10

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases

Brief summary

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.

Interventions

DRUGCalcium alpha-ketoglutarate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean change in aqueous humor aKG level	Baseline and post-supplementation, approximately 28 days	To evaluate the mean difference in fold-change in aKG levels from baseline to post-supplementation in eye fluid

Secondary

Measure	Time frame	Description
Mean fold-change in metabolic and retinal pathways	Baseline and post-supplementation, approximately 28 days	To calculate mean fold-change in retinal metabolic and protein pathways from baseline to post-supplementation in eye fluid

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVinit Mahajan, MD, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026