Pistachio Group for Macular Degeneration

Overseen By Tammy Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Fat absorption drugs

Disqualifiers: Tree nut allergy, Eye disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether eating pistachios, rich in the nutrients lutein and zeaxanthin, can help protect against age-related macular degeneration (AMD), a leading cause of vision loss in older adults. Participants will either consume a daily portion of pistachios or maintain their usual diet for 12 weeks. The trial seeks individuals with low levels of these nutrients in their diet and low macular pigment density (a measure of eye health) who have not been diagnosed with eye diseases like macular degeneration. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on the dietary impacts on eye health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on lipid-lowering medication, you can participate as long as you continue your current regimen throughout the study.

What prior data suggests that pistachios are safe for eye health?

Research shows that eating pistachios might benefit eye health. Studies have found that pistachios can increase a protective pigment in the eye, which helps shield the retina from light damage. This protection is important for preventing age-related macular degeneration (AMD).

Regarding safety, pistachios are generally safe to eat as they are a common food. These studies have not reported any negative effects from consuming pistachios. Many people already include pistachios in their regular diet, so they are considered safe in normal amounts. However, consider any personal allergies or dietary restrictions before adding something new to your diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for macular degeneration, which often involve injections or medications like anti-VEGF drugs, the pistachio treatment is unique because it's a simple dietary approach. Researchers are excited about this because pistachios are rich in nutrients like lutein and zeaxanthin, which are known to support eye health. This treatment is non-invasive and easy to incorporate into daily life, potentially offering a natural alternative to more complex medical interventions.

What evidence suggests that pistachios might be an effective treatment for macular degeneration?

Research has shown that pistachios might help protect against vision loss from age-related macular degeneration (AMD). Studies have found that eating pistachios can increase the density of pigments in the eye, which is linked to better eye health. Pistachios are rich in lutein and zeaxanthin, nutrients that help protect the retina from light damage. One study found that eating pistachios every day increased these protective pigments in the eyes of healthy adults. This trial will evaluate the effects of daily pistachio consumption on eye health, with participants in the Pistachio Group consuming one 2-ounce pack of pistachios every day over the 12-week study. This suggests that adding pistachios to the diet could be an easy way to support eye health as one ages. ^{4 6 7 8 9}

Who Is on the Research Team?

Tammy Scott

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

Inclusion Criteria

Low lutein and zeaxanthin intake at baseline (<2 mg/d)

Adult men and women, aged 40 - 70 years

Low macular pigment density at baseline (<0.5 OD)

Exclusion Criteria

Individuals on lipid-lowering medication will be considered if they maintain their regimen throughout the study and meet all inclusion/exclusion criteria.

Inability to perform the heteroflicker photometry procedures with or without corrective lenses (i.e. glasses or contact lenses) during in-house screening

Atrophic gastritis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pistachio nuts in 2-ounce packs daily for 12 weeks

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pistachio Group

How Is the Trial Designed?

Group I: Pistachio Group Experimental Treatment 1 Intervention

The pistachio group will receive pistachio nuts in 2-ounce packs. This group will consume one pack every day over the course of the 12-week study.

Group II: Control (Usual Diet) Group Active Control 1 Intervention

The control group will not receive pistachio nuts. They will be asked to make no changes and continue to eat their regular diet.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

American Pistachio Growers

Collaborator

Trials

6

Recruited

320+

Published Research Related to This Trial

In a study of 494 patients with neovascular age-related macular degeneration (nAMD) followed for 12 months, higher dietary zinc intake was linked to a 49% reduced likelihood of sub-retinal fluid (SRF) presence, suggesting a protective effect against this complication.

Conversely, higher dietary intake of β-carotene was associated with nearly double the odds of intra-retinal fluid (IRF) and pigment epithelial detachment (PED), indicating that certain dietary components may increase risks for specific conditions in nAMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary antioxidants are associated with presence of intra- and sub-retinal fluid in neovascular age-related macular degeneration after 1 year. Dharamdasani Detaram, H., Liew, G., Russell, J., et al.[2021]

In a study of 547 patients with neovascular age-related macular degeneration (nAMD), those with higher dietary intake of flavonoids, particularly flavonols and flavan-3-ols, showed better visual acuity and lower risk of intra-retinal fluid (IRF) after 12 months of anti-VEGF therapy.

Participants in the lowest tertile of flavonoid intake had significantly worse vision and a twofold higher risk of IRF compared to those in the highest tertile, suggesting that dietary flavonoids may enhance treatment outcomes for nAMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary flavonoids are associated with longitudinal treatment outcomes in neovascular age-related macular degeneration. Detaram, HD., Liew, G., Lewis, JR., et al.[2021]

Citations

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news-medical.net

news-medical.net/news/20241028/Study-finds-pistachios-might-help-guard-against-vision-loss.aspx

Study finds pistachios might help guard against vision loss

New chip restores reading ability for macular degeneration patients.

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researchgate.net

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Pistachio Consumption Increases Macular Pigment Optical ...

... benefits of pistachio nuts (Pistacia vera L.). Pistachios are a good source of protein, fiber, monounsaturated fatty acids, minerals and ...

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withpower.com

withpower.com/trial/phase-retinal-diseases-2-2022-77ecb

Pistachio Group for Macular Degeneration

Disqualifiers: Tree nut allergy, Eye disease, Diabetes, others. No Placebo ... What data supports the effectiveness of the Pistachio Group treatment for macular ...

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macularhope.org

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Daily consumption of pistachios boosts macular pigment ...

“Pistachios are unique as they are the only tree nut to contain substantial amounts of lutein, but the average consumption of tree nuts is low ...

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studyfinds.org

studyfinds.org/pistachios-protect-eyesight/

Just 2 handfuls of pistachios daily could help protect your ...

... degeneration (AMD), one of the leading causes of vision loss in older adults. What makes pistachios special is that they're the only nuts ... data ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39426460/

Pistachio Consumption Increases Macular Pigment Optical ...

The results of our study demonstrate that a dietary intervention with pistachios is efficacious in increasing MPOD in healthy adults.

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americanpistachios.org

americanpistachios.org/about-us/pistachio-power-unshelled/press-releases/pistachios-support-eye-health

New Study Shows Eating Pistachios Daily Can Support ...

This important part of the eye filters harmful blue (visible) light and protects against age-related macular degeneration (AMD), which is one of the leading ...

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modernod.com

modernod.com/significant-findings/prescribe-pistachios-to-improve-patient-ocular-health

Prescribe Pistachios to Improve Patient Ocular Health

... macular pigment optical density, which studies show is essential for retinal health and reducing the risk of age-related macular degeneration.

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sciencedirect.com

sciencedirect.com/science/article/pii/S002231662401099X

Pistachio Consumption Increases Macular Pigment Optical ...

Progression of age-related macular degeneration: Association with dietary fat, transunsaturated fat, nuts, and fish intake ... macular degeneration, Eye Disease ...