- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283941
Pistachios and Neural Macular Pigment
Pistachios and Neural Macular Pigment; a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tammy Scott, PhD
- Phone Number: 617-962-1496
- Email: tammy.scott@tufts.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Recruiting
- Clinical and Translational Research Center (CTRC) - Tufts
-
Contact:
- Olaniyi Ogunbodede
- Phone Number: 617-636-4714
- Email: oogunbodede@tuftsmedicalcenter.org
-
Contact:
- Rupali Ranade
- Phone Number: (617) 636-4714
- Email: rranade@tuftsmedicalcenter.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Consumption of 2-ounce packs of pistachio nuts, daily, for 12 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Macular Pigment (MP) Density over 12 weeks
Time Frame: Measured at baseline, 6 weeks and 12 weeks.
|
A non-invasive psychophysical technique, known as heterochromatic flicker photometry (HFP), will be used to measure MP density of the retina.
|
Measured at baseline, 6 weeks and 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum concentrations of lutein and zeaxanthin (dietary carotenoids)
Time Frame: Measured at baseline and 12 weeks.
|
Serum carotenoids will be measured by HPLC.
|
Measured at baseline and 12 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tammy Scott, Tufts University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N322001 FSU054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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