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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Low glycemic Mediterranean diet behavioral modification
BehavioralParticipants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour
Treatment groups
Trial 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.
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: