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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Low glycemic Mediterranean diet behavioral modification

    Behavioral

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: low glycemic Mediterranean diet behavioral modificationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

National Eye Institute (NEI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: