Not yet recruiting NCT07605468
Feasibility Study of a Remote Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low glycemic Mediterranean diet behavioral modification.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nonrandomized, Unmasked Feasibility Study of a Remote-based Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension (GLOVE)
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.
Interventions
- 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
Primary outcome measures
- Success rate of the diet behavioral modification [Time frame: baseline through one year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California, Los Angeles — Los Angeles
Identifiers
NCT: NCT07605468 · 73980 · R34EY035782