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

Early Phase 1CompletedNCT07269704

Stanford University17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Eye Diseases

Interventions

Calcium alpha-ketoglutarateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Byers Eye Institute

Palo Alto, California, United States

Outcomes

Primary Outcomes

Mean change in aqueous humor aKG level

To evaluate the mean difference in fold-change in aKG levels from baseline to post-supplementation in eye fluid

Time frame: Baseline and post-supplementation, approximately 28 days

Secondary Outcomes

Mean fold-change in metabolic and retinal pathways

To calculate mean fold-change in retinal metabolic and protein pathways from baseline to post-supplementation in eye fluid

Time frame: Baseline and post-supplementation, approximately 28 days

Data from ClinicalTrials.gov

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