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Goji Berries vs. Fiber for Age-Related Macular Degeneration (GOJI Trial)
N/A
Recruiting
Led By Robert M Hackman, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
50 - 95 years of age
Be older than 18 years old
Must not have
Current or planned use of a blood thinner (e.g., Coumadin, Warfarin) at any time during study
Any physical characteristic or condition that precludes ability to perform study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and day 180
Awards & highlights
Summary
This trial aims to study how consuming goji berries or a similar amount of fiber for six months affects the eye health, gut bacteria, skin carotenoid levels, and lipoprotein profiles of
Who is the study for?
This trial is for people aged 50-80 who have been diagnosed with small drusen, a sign of early age-related macular degeneration (AMD), by a retinal specialist. Participants must be willing and able to follow the study's rules.
What is being tested?
The study compares the effects of eating goji berries versus consuming an equivalent amount of fiber on visual health in those at risk for AMD. Each participant will either eat 28g of goji berry or take fiber five days a week for six months.
What are the potential side effects?
Potential side effects may include digestive changes due to increased fiber intake from either goji berries or the fiber supplement. Individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 95 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently using or plan to use a blood thinner during the study.
Select...
I can perform all required study procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 and day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Macular pigment optical volume (MPOV)
Secondary outcome measures
Cognitive function
Color Fundus Photography (CFP)
Dark adaptometry
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Goji berryExperimental Treatment1 Intervention
For the goji berry arm, participants will consume goji berries.
Group II: FiberActive Control1 Intervention
For the fiber arm, participants will consume fiber supplements that closely matches the fiber type and amount found in the portion of goji berries.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goji berry
2019
N/A
~40
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,958 Total Patients Enrolled
United States Department of Agriculture (USDA)FED
100 Previous Clinical Trials
286,619 Total Patients Enrolled
Robert M Hackman, PhDPrincipal InvestigatorUniversity of California, Davis
4 Previous Clinical Trials
134 Total Patients Enrolled
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