Effects of Goji vs. Fiber on Macular Degeneration
ConditionAge-Related Macular Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-95
SponsorUniversity of California, Davis
About this trial
The goal of this project is to conduct a clinical trial in 60 participants ranging from age 65-95 who are at risk for age-related macular degeneration (AMD). The study will evaluate the effects of 14g of goji berry intake or an equivalent amount and type of fiber, five days a week for six months, on visual health, gut microbiome profiles, skin carotenoid measures, and lipoprotein profiles.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Family history of AMD
Hyperlipidemia or managed diabetes
65 - 95 years of age
Disqualifiers
Dislike of, or allergy to, goji berries or any of the ingredients in the fiber-rich wafers and gummies (wheat, corn, oats, soy, natural orange flavor, xylitol, annatto, pectin, or other food ingredients)
Consumption of > 2 alcoholic drinks per day
Indications of substance or alcohol abuse
Current or planned use of a blood thinner (e.g., Coumadin, Warfarin) at any time during study
Trial design
Design model
Parallel
Treatments tested in this trial
Goji berry
Dietary supplementParticipants will be instructed to consume 14 grams of goji berries 5 days a week for 6 months
Fiber
Dietary supplementParticipants will be instructed to consume the fiber supplements 5 days a week for 6 months
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Goji berryExperimental treatment 1 intervention
Group B: FiberActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Macular pigment optical volume (MPOV)
MPOV provides an objective measure of macular pigments by using dual wavelength autofluorescence using the Heidelberg Spectralis to obtain HRA + OCT measures
Time frame
Day 0 and Day 180Secondary outcomes
1
Stool microbiome
Metagenomic sequencing
Time frame
Day 0 and Day 1802
Spectral Domain-Ocular Coherence Tomography (SD-OCT)
Central subfield thickness will be measured using the OCT instrument's algorithm
Time frame
Day 0 and Day 1803
Fundus autofluorescence (FAF)
Blue FAF imaging will be performed to assess variations in lipofuscin autofluorescence
Time frame
Day 0 and Day 1804
Color Fundus Photography (CFP)
CFP imaging uses a standard retinal camera.
Time frame
Day 0 and Day 180Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator
Source ClinicalTrials.gov