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

May 18, 2026 updated by: Mary Elizabeth Hartnett, Stanford University

Nonrandomized, Unmasked Feasibility Study of a Remote-based Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension (GLOVE)

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low glycemic Mediterranean diet behavioral modification
Participants receive recommendations to modify their diets to be low glycemic and adhere to Mediterranean diet Participants wear continuous glucose monitors for 2 weeks for one year.
Behavioral: Low glycemic Mediterranean diet behavioral modification
Participants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the diet behavioral modification
Time Frame: baseline through one year

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.
baseline through one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Mary E Hartnett, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73980
  • R34EY035782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be shared among UCLA, Dartmouth, Tufts and Stanford

IPD Sharing Time Frame

5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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