Status:
UNKNOWN
Pistachios and Neural Macular Pigment
Lead Sponsor:
Tufts University
Collaborating Sponsors:
American Pistachio Growers
Conditions:
Macular Degeneration
Retinal Degeneration
Eligibility:
All Genders
40-70 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05283941
Start Date
June 10 2022
End Date
November 30 2023
Last Update
March 9 2023
Active Locations (1)
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1
Clinical and Translational Research Center (CTRC) - Tufts
Boston, Massachusetts, United States, 02111