Clinical trial NCT05283941: Pistachios and Neural Macular Pigment
Official title: Pistachios and Neural Macular Pigment; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Keywords: age related macular degeneration
lutein
zeaxanthin
pistachios
macular pigment
AMD
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: American Pistachio Growers
First posted: 2022-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

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

Primary outcomes:
measure: Change from baseline Macular Pigment (MP) Density over 12 weeks
timeFrame: Measured at baseline, 6 weeks and 12 weeks.
Secondary outcomes:
measure: Serum concentrations of lutein and zeaxanthin (dietary carotenoids)
timeFrame: Measured at baseline and 12 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Clinical and Translational Research Center (CTRC) - Tufts
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Tammy Scott
role: PRINCIPAL_INVESTIGATOR
References: