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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07605468
Acronym
GLOVE
Enrollment
32
Registered
2026-05-26
Start date
2026-06-01
Completion date
2028-06-01
Last updated
2026-05-26

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

Conditions

Age-Related Macular Degeneration

Brief summary

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.

Interventions

BEHAVIORALLow 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

Sponsors

Stanford University
Lead SponsorOTHER
National Eye Institute (NEI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Success rate of the diet behavioral modificationbaseline through one yearSuccess 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMary E Hartnett, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026