Recruiting

Pistachios & Neural Pigment

Sponsor:

Tufts University

Code:

NCT05283941

Conditions

Macular Degeneration

Retinal Degeneration

Retinal Diseases

Eye Diseases

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Pistachio Group

Study Details

Brief summary:

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss as people age. Studies have shown that lutein and zeaxanthin, nutrients found in green leafy vegetables and egg yolks, can help protect against AMD in older adults. These nutrients form a pigment in the retina (macular pigment) that can help protect the retina from light damage. Pistachios are rich sources of both lutein and zeaxanthin; thus, dietary intake of pistachios could serve as a beneficial food source for eye health.

Conditions

Macular Degeneration

Retinal Degeneration

Retinal Diseases

Eye Diseases

Study ID

NCT05283941

Start date

Jun 10, 2022

Status verified date

Mar, 2023

Completion date

Nov 30, 2023

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Adult men and women, aged 40 - 70 years
2. Body Mass Index (BMI): 20.0 - 36.9 kg/m2
3. Low macular pigment density at baseline (<0.5 OD)
4. Low lutein and zeaxanthin intake at baseline (<2 mg/d)

Exclusion Criteria:

1. Inability to perform the heteroflicker photometry procedures with or without corrective lenses (i.e. glasses or contact lenses) during in-house screening.
2. History of (self-reported):

  • Fat malabsorption
  • Use of drugs that interfere with fat absorption or metabolism
  • Tree nut allergy
  • Eye disease, including macular degeneration and cataracts
  • Small bowel disease or resection
  • Atrophic gastritis
  • Hyperlipidemia
  • Insulin-requiring diabetes
  • > 14 alcoholic drinks per week
  • Pancreatic disease
  • Bleeding disorders
  • Pregnancy (or hoping to become pregnant during participation in the study)
  • Carotenoid or fatty acid dietary supplements within 2 months of the study
  • Non-English speaker
  • Any condition that would make it unlikely that the participant would be able to complete the requirements of the study.

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pistachio Group

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.

no intervention: Control (Usual Diet) Group

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

Interventions

Pistachio Group

Consumption of 2-ounce packs of pistachio nuts, daily, for 12 weeks.

Primary outcome measure

  • Change from baseline Macular Pigment (MP) Density over 12 weeks [ Time Frame: Measured at baseline, 6 weeks and 12 weeks. ]

Central Contacts and Locations

Central contacts

Locations

Clinical and Translational Research Center (CTRC) - Tufts

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

More Information

Sponsor

Tufts University

Last update posted

Mar 9, 2023

Last verified

Mar, 2023

Keywords

  • age related macular degeneration
  • lutein
  • zeaxanthin
  • pistachios
  • macular pigment
  • AMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts University on 2023-03-09.