Feasibility Study of a Remote Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension

N/ANot Yet RecruitingNCT07605468

Stanford University32 enrolled

Overview

The primary goal of the study is to test dietary intervention at glycemic control and carotenoid levels in participants with intermediate age-related macular degeneration.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Age-Related Macular Degeneration

Interventions

Low glycemic Mediterranean diet behavioral modificationBEHAVIORAL

Participants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of early to intermediate AMD with no history of retinal geographic atrophy (cRORA) or exudative disease * Eating a diet less healthy than average (Healthy Eating Index \[HEI\] score \<61) based on 3 24-hour dietary recalls * Access to a computer or smart phone for use in the behavioral meetings (we will provide loaners for those lacking a smart phone * Because the initial questionnaires (ASA24), surveys and informed consent will be on line and in English, only individuals with fluency in English will be included. (They do not need to list English as their primary language.) Exclusion Criteria: * HbA1c greater than 6.5%, * Diabetes or medications used to treat diabetes or obesity (including GLP1 agonists, metformin, glyburide * Use of statins, niacin or other lipid/cholesterol modifying medications * Recent cancer (within past 3 years) * Other retinal or ocular pathology (other than pseudophakia and/or refractive error (between -8 to +8 diopter spherical equivalence)

Locations (1)

University of California, Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Success rate of the diet behavioral modification

Success rate of the behavioral modification of the diet based on self-reported assessments and in association with systemic markers of improved health due to dietary modifications. Continuous glucose monitoring measurements will be used to determine the proportion of time glucose \>140 mg/dL for 24 hr/day for two weeks at each visit. The definition of success will be halving the time glucose is \>140 mg/dL.

Time frame: baseline through one year

Data from ClinicalTrials.gov

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