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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the Pistachio Group treatment for macular degeneration?

Research suggests that dietary antioxidants, like those found in fruits and vegetables, are linked to better outcomes in macular degeneration, which might imply that components in pistachios could be beneficial too. ^{1 2 3 4 5}

How is the Pistachio Group treatment different from other treatments for macular degeneration?

The Pistachio Group treatment may be unique due to its potential focus on dietary components, as research suggests that antioxidants found in foods like fruits, vegetables, and nuts can influence macular health. This approach might differ from standard treatments that often involve medications or injections. ^{5 6 7 8 9}

What is the purpose of this trial?

This trial tests if eating pistachios can help older adults by protecting their eyes from light damage and improving brain function. Pistachios contain nutrients that are beneficial for eye and brain health. Pistachios contain protein, carbohydrate, dietary fibers, fat, folic acid, vitamin K, magnesium and potassium, gama-tocopherols, phytochemicals, and polyphenols, which have antioxidant and anti-inflammatory functions.

Research Team

Tammy Scott

Principal Investigator

Tufts University

Eligibility Criteria

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

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

Treatment Details

Interventions

• Pistachio Group

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Dietary flavonoids are associated with longitudinal treatment outcomes in neovascular age-related macular degeneration. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of saffron supplementation on retinal flicker sensitivity in early age-related macular degeneration. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cataract surgery in patients with age-related macular degeneration: one-year outcomes. [2019]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Age-related maculopathy in a multiracial United States population: the National Health and Nutrition Examination Survey III. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Racial/ethnic differences in age-related maculopathy. Third National Health and Nutrition Examination Survey. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary antioxidants and age-related maculopathy: the Blue Mountains Eye Study. [2016]