Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease (OAK AGE)

Stanford University

Status and phase: Completed; Phase 1

Conditions: Eye Diseases

Treatments: Drug: Calcium alpha-ketoglutarate

Study type: Interventional

Funder types: Other

Identifiers

NCT07269704

68157

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Calcium alpha-ketoglutarate (Ca-aKG)

Experimental group

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.

Treatment:

Drug: Calcium alpha-ketoglutarate