Pistachios and Neural Macular Pigment

NCT ID: NCT05283941

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2023-11-30

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.

Detailed Description

Lutein and its isomer zeaxanthin (L/Z) are dietary carotenoids that cross the blood brain barrier and exclusively accumulate in the macular region of the retina, where they are referred to as macular pigment (MP). MP density (MPD) has been reported to be significantly related to decreased risk of age-related macular degeneration as well as cognitive function in both young and older adults. Studies in non-human primates and humans find that MPD is significantly related to lutein brain concentrations. MPD, a non-invasive measure, is thus a biomarker for brain concentrations of L/Z. This may be of interest given the report that L/Z concentrations in the older adult brain are positively related to a variety of pre mortem cognitive measures. Furthermore, L/Z supplementation was found to significantly improve verbal fluency scores in healthy older adults. Pistachios are a bioavailable source of L/Z. L/Z are transported in the circulation primarily on high density lipoproteins (HDL) and HDL levels were found to be significantly related to MPD. Thus, increasing dietary intake of L/Z as well as changing lipoprotein levels may impact MPD. This is of interest given that a pistachio enriched diet has been reported to improve lipid profile in healthy and mild hypercholesterolemic patients. Based on the sum of these findings, the objective of this study was to investigate the effect of a long-term pistachio intervention on MPD.

The overall goal of the proposal is to determine whether the consumption of pistachios is a practical way to increase L/Z status. This will primarily be accomplished by performing a nutritional study to demonstrate that pistachios are a bioavailable source of L/Z to neural tissue (i.e., MP). Cross-sectional and intervention studies report a significant relationship between L/Z levels and ocular and cognitive health. Current L/Z intakes in the U.S. are lower than levels associated with health. This randomized, parallel study will test the efficacy of pistachios on increasing L/Z neural status (i.e., MPD).

Conditions

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pistachio Group

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pistachio Group

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Pistachio Growers

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tammy Scott

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Clinical and Translational Research Center (CTRC) - Tufts

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tammy Scott, PhD

Role: CONTACT

tammy.scott@tufts.edu

617-962-1496

Facility Contacts

Olaniyi Ogunbodede

Role: primary

oogunbodede@tuftsmedicalcenter.org

617-636-4714

Rupali Ranade

Role: backup

rranade@tuftsmedicalcenter.org

(617) 636-4714

References

Scott TM, Ogunbodede O, McKay DL, Johnson EJ. Pistachio Consumption Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Controlled Trial. J Nutr. 2025 Jan;155(1):168-174. doi: 10.1016/j.tjnut.2024.10.022. Epub 2024 Oct 18.

Reference Type: DERIVED

PMID: 39426460 (View on PubMed)

Other Identifiers

N322001 FSU054

Identifier Type: -

Identifier Source: org_study_id