Pistachios and Neural Macular Pigment
Primary Purpose
Macular Degeneration, Retinal Degeneration, Retinal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pistachio Group
Sponsored by
About this trial
This is an interventional prevention trial for Macular Degeneration focused on measuring age related macular degeneration, lutein, zeaxanthin, pistachios, macular pigment, AMD
Eligibility Criteria
Inclusion Criteria:
- Adult men and women, aged 40 - 70 years
- Body Mass Index (BMI): 20.0 - 36.9 kg/m2
- Low macular pigment density at baseline (<0.5 OD)
- Low lutein and zeaxanthin intake at baseline (<2 mg/d)
Exclusion Criteria:
- Inability to perform the heteroflicker photometry procedures with or without corrective lenses (i.e. glasses or contact lenses) during in-house screening.
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.
Sites / Locations
- Clinical and Translational Research Center (CTRC) - TuftsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pistachio Group
Control (Usual Diet) Group
Arm Description
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.
The control group will not receive pistachio nuts. They will be asked to make no changes and continue to eat their regular diet.
Outcomes
Primary Outcome Measures
Change from baseline Macular Pigment (MP) Density over 12 weeks
A non-invasive psychophysical technique, known as heterochromatic flicker photometry (HFP), will be used to measure MP density of the retina.
Secondary Outcome Measures
Serum concentrations of lutein and zeaxanthin (dietary carotenoids)
Serum carotenoids will be measured by HPLC.
Full Information
NCT ID
NCT05283941
First Posted
February 22, 2022
Last Updated
March 7, 2023
Sponsor
Tufts University
Collaborators
American Pistachio Growers
1. Study Identification
Unique Protocol Identification Number
NCT05283941
Brief Title
Pistachios and Neural Macular Pigment
Official Title
Pistachios and Neural Macular Pigment; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
American Pistachio Growers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
Keywords
age related macular degeneration, lutein, zeaxanthin, pistachios, macular pigment, AMD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pistachio Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Usual Diet) Group
Arm Type
No Intervention
Arm Description
The control group will not receive pistachio nuts. They will be asked to make no changes and continue to eat their regular diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pistachio Group
Intervention Description
Consumption of 2-ounce packs of pistachio nuts, daily, for 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline Macular Pigment (MP) Density over 12 weeks
Description
A non-invasive psychophysical technique, known as heterochromatic flicker photometry (HFP), will be used to measure MP density of the retina.
Time Frame
Measured at baseline, 6 weeks and 12 weeks.
Secondary Outcome Measure Information:
Title
Serum concentrations of lutein and zeaxanthin (dietary carotenoids)
Description
Serum carotenoids will be measured by HPLC.
Time Frame
Measured at baseline and 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult men and women, aged 40 - 70 years
Body Mass Index (BMI): 20.0 - 36.9 kg/m2
Low macular pigment density at baseline (<0.5 OD)
Low lutein and zeaxanthin intake at baseline (<2 mg/d)
Exclusion Criteria:
Inability to perform the heteroflicker photometry procedures with or without corrective lenses (i.e. glasses or contact lenses) during in-house screening.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Scott, PhD
Phone
617-962-1496
Email
tammy.scott@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Scott
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Research Center (CTRC) - Tufts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olaniyi Ogunbodede
Phone
617-636-4714
Email
oogunbodede@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Rupali Ranade
Phone
(617) 636-4714
Email
rranade@tuftsmedicalcenter.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Pistachios and Neural Macular Pigment
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