Dietary Intervention for Age-Related Macular Degeneration

(GLOVE Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a low glycemic Mediterranean diet affects individuals with early to intermediate age-related macular degeneration (AMD), a common eye condition that can lead to vision loss. Researchers aim to determine if this diet can help manage blood sugar and carotenoid levels, potentially influencing AMD progression. Participants will follow a specific diet plan and wear a glucose monitor for two weeks over the course of a year. This trial suits those diagnosed with early to intermediate AMD who feel their current diet is unhealthy and have access to a computer or smartphone for online meetings. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on dietary impacts on AMD.

Will I have to stop taking my current medications?

If you are taking medications for diabetes, obesity, or cholesterol, you will need to stop them to participate in this trial. The trial does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this dietary intervention is safe for participants with age-related macular degeneration?

Research has shown that following a Mediterranean diet, rich in vegetables, fruits, beans, fish, and grains, can help protect against age-related macular degeneration (AMD). Those who adhere to this diet have a lower risk of their AMD worsening. For instance, one study found that maintaining a Mediterranean diet reduced the risk of advanced AMD by up to 41%.

Regarding safety, specific data from clinical trials on the low glycemic Mediterranean diet is limited. However, the Mediterranean diet is widely recognized as healthy and is often recommended for overall well-being. This trial is in the "Not Applicable" phase, focusing on exploring the diet's benefits rather than testing a new drug, suggesting that the diet is generally considered safe for most people.12345

Why are researchers excited about this trial?

Unlike standard treatments for age-related macular degeneration, which often involve injections or medications aiming to slow vision loss, this dietary intervention focuses on modifying lifestyle through a low glycemic Mediterranean diet. This approach is unique because it doesn't rely on pharmaceuticals but instead uses dietary changes to manage the condition. Researchers are excited about this trial because it explores how diet can influence blood sugar levels and potentially improve eye health, offering a non-invasive and holistic alternative to traditional treatments.

What evidence suggests that this dietary intervention might be effective for age-related macular degeneration?

Research has shown that a Mediterranean diet can help protect against age-related macular degeneration (AMD). Studies indicate that following this diet may lower the risk of developing advanced AMD by 34% to 41%. This trial will evaluate a low glycemic Mediterranean diet behavioral modification, where participants receive recommendations to modify their diets to be low glycemic and adhere to a Mediterranean diet. Rich in antioxidants and anti-inflammatory properties, this diet is believed to offer protective effects. It emphasizes fruits, vegetables, whole grains, and healthy fats like olive oil. This way of eating has been linked to slowing the progression of AMD, helping to maintain healthier eyes over time.13467

Who Is on the Research Team?

ME

Mary E Hartnett, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for people diagnosed with early to intermediate age-related macular degeneration (AMD). Participants should be able to follow a diet plan and take part in remote behavioral sessions.

Inclusion Criteria

Access to a computer or smart phone for use in the behavioral meetings (loaners provided for those lacking a smart phone)
Eating a diet less healthy than average (Healthy Eating Index [HEI] score <61) based on 3 24-hour dietary recalls
Fluency in English for completing initial questionnaires, surveys, and informed consent online
See 1 more

Exclusion Criteria

I have had cancer within the past 3 years.
I am taking medication to lower my cholesterol.
HbA1c greater than 6.5%
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive recommendations to modify their diets to be low glycemic and adhere to a Mediterranean diet. Participants wear continuous glucose monitors for 2 weeks for one year.

1 year
Continuous glucose monitoring every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Low glycemic Mediterranean diet behavioral modification

Trial Overview

The study tests if following a low glycemic Mediterranean diet, supported by remote coaching, can help control blood sugar and improve eye health in people with AMD.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: low glycemic Mediterranean diet behavioral modificationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Citations

The Mediterranean Diet and Age-Related Eye Diseases - PMC

In general, the protective effects of MD against AMD were confirmed. While most studies reported a decrease in AMD incidence and alleviation of AMD progression, ...

Effect of the Mediterranean Diet on Progression of Dry ...

The aim of this study was to investigate the possible effect of the Mediterranean diet (Med Diet) on the progression of age-related macular degeneration (AMD)

ARVO 2018: Studies Show Mediterranean Diet May Lower ...

ARVO 2018: Studies Show Mediterranean Diet May Lower Advanced AMD Risk ... age-related macular degeneration (AMD) by 39 percent. The ...

Mediterranean Diet on Development and Progression of ...

A Mediterranean diet (MD) has been suggested to provide protective effects against AMD development and progression due to its antioxidant and anti-inflammatory ...

Mediterranean diet may protect against macular ...

The Mediterranean diet reduces the risk of age-related macular degeneration (AMD), according to a study of two Portuguese populations.

Mediterranean Diet: Healthy Eating for Healthier Eyes

Researchers found lower rates of macular degeneration among people who ate more vegetables, legumes (beans), fish, cereals, and especially fruits.

Mediterranean Diet - Ocular Wellness & Nutrition ...

Conclusions: Pooling data from the RS-I and Alienor Study, higher adherence to the MeDi was associated with a 41% reduced risk of incident advanced AMD. These ...