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Carotenoids
Pistachio Group for Macular Degeneration
N/A
Recruiting
Led By Tammy Scott
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 6 weeks and 12 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if eating pistachios can help older adults by protecting their eyes from light damage and improving brain function. Pistachios contain nutrients that are beneficial for eye and brain health. Pistachios contain protein, carbohydrate, dietary fibers, fat, folic acid, vitamin K, magnesium and potassium, gama-tocopherols, phytochemicals, and polyphenols, which have antioxidant and anti-inflammatory functions.
Eligible Conditions
- Age-Related Macular Degeneration
- Retinal Degeneration
- Retinal Disease
- None
- Herpes simplex retinopathy
- Eye Diseases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, 6 weeks and 12 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 6 weeks and 12 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline Macular Pigment (MP) Density over 12 weeks
Secondary study objectives
Serum concentrations of lutein and zeaxanthin (dietary carotenoids)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pistachio GroupExperimental Treatment1 Intervention
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 II: Control (Usual Diet) GroupActive Control1 Intervention
The control group will not receive pistachio nuts. They will be asked to make no changes and continue to eat their regular diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pistachio Group
2017
N/A
~120
Find a Location
Who is running the clinical trial?
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
596,078 Total Patients Enrolled
American Pistachio GrowersOTHER
4 Previous Clinical Trials
230 Total Patients Enrolled
Tammy ScottPrincipal InvestigatorTufts University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink more than 14 alcoholic drinks in a week.Your body mass index (BMI) should be between 20.0 and 36.9 kg/m2.You have taken carotenoid or fatty acid dietary supplements within the past 2 months.You have a history of problems absorbing fat from your food.You are taking medications that affect how your body absorbs or processes fat.You are allergic to tree nuts.You have a condition where your small bowel is affected or have had surgery to remove part of your small bowel.
Research Study Groups:
This trial has the following groups:- Group 1: Pistachio Group
- Group 2: Control (Usual Diet) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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