Age-Related Macular DegenerationGOJINCT06237127
Effects of Goji vs. Fiber on Macular Degeneration
A study testing Goji berry and Fiber in people with Age-Related Macular Degeneration, run by University of California, Davis at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Goji berry and Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Family history of AMD
- Hyperlipidemia or managed diabetes
- 65 - 95 years of age
Who cannot join
- 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
- Use of multi-vitamin or any other supplements that contain lutein and/or zeaxanthin (if willing to stop the supplement, subject can be enrolled 6 months from stop date)
- Taking any new medications started within the past 6 months, or changes in medication regimen planned in the next 6 months (stable use greater than 6 months is not exclusionary)
Show all 13Show fewer
- Any planned international travel during the study
- Consuming >3 servings/day of a combination of spinach, kale, lettuce, orange bell peppers, corn, parsley, squash, broccoli, pumpkin, edamame
- Regularly consuming >3 eggs/day
- Currently participating in any other interventional research study
- Diagnosed with inflammatory bowel disease, irritable bowel syndrome, other gastrointestinal disorder, undergoing cancer therapy or immunocompromised, or diagnosis of another condition where lutein, zeaxanthin and/or fiber supplementation would be contraindicated or would interfere with ability to participate in the study
- Any physical characteristic or condition that precludes ability to perform study procedures
- Medical or psychiatric condition that, in the opinion of the Investigator, would compromise study findings or prevent the participant from completing the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Eye Center, Tschannen Eye Institute
Sacramento, California, 95817
Denise C Macias, 916-734-6303, dcmacias@ucdavis.edu
Susan M Garcia, 916-734-4546, smgarcia@ucdavis.edu
About this study
Official title: Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical 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.
Read the detailed description
Age-related macular degeneration (AMD) is the third leading cause of blindness worldwide. The disease occurs when the macula in the central retina develops lesions due, in part, to the loss of the protection of macular pigments zeaxanthin, lutein, and meso-zeaxanthin, which are responsible for light filtering and oxidative defense. The major risk factor for AMD is aging, and currently, no definitive prevention for AMD exists.
Goji berry (Lycium Barbarum) is a fruit that has been used as traditional medicine in Asian countries for more than 2,000 years. Modern science has identified potential benefits of the berry in oxidant defense, immune regulation, diabetes, and vision in animal and cell models. Nonetheless, evidence regarding the effects of goji berries on human health is scarce. The bioactive components of goji berries include zeaxanthin, lutein, Lycium Barbarum polysaccharides-protein complex, betaine, cerebroside, minerals, and vitamins. Importantly, goji berries contain the highest concentration of zeaxanthin among all commonly consumed foods.
Previous clinical studies have shown that goji berries have a high bioavailability of zeaxanthin, and that macular pigment optical density (MPOD) was increased after supplementation. This study uses macular pigment optical volume (MPOV; a measure that integrates MPOD across multiple macular eccentricities) as the primary outcome measure. It is unknown if the changes in MPOV will be associated with other functional changes or anatomic conditions in the eye among a population with small drusen, a risk factor for AMD. In addition, the impact of goji berry intake on the gut microbiome profile and associated metabolites is unknown, and potentially important in understanding the mechanism(s) of action.
Participants who meet the eligibility criteria will be enrolled and will be randomized 1:1 to the goji berry arm or fiber arm of the study. Over the course of approximately 180 days, participants will consume the assigned food item five days per week and attend three study visits.
Study visits will include ophthalmic imaging and testing, skin carotenoid measurements, completion of a food record, height, weight, handgrip strength, blood pressure measurement, and fasting blood collection. At 2 timepoints participants will be asked to provide a stool sample (collected within 24 hours of visit).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Goji berry, Fiber
- Keywords
- Goji Berry, Age-Related Macular Degeneration, Lutein, Zeaxanthin, Fiber, Carotenoids, Gut Microbiome, HDL, Cholesterol Efflux Capacity, Eye Health
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goji berryDietary supplement
Participants will be instructed to consume 14 grams of goji berries 5 days a week for 6 months
FiberDietary supplement
Participants will be instructed to consume the fiber supplements 5 days a week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Goji berry | Experimental | For the goji berry arm, participants will consume goji berries. Receives: Dietary Supplement: Goji berry |
| Fiber | Active comparator | For the fiber arm, participants will consume fiber supplements that closely matches the fiber type and amount found in the portion of goji berries. Receives: Dietary Supplement: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 and Day 180
Secondary outcomes (13)
Stool microbiome
Metagenomic sequencing
Measured: Day 0 and Day 180
Spectral Domain-Ocular Coherence Tomography (SD-OCT)
Central subfield thickness will be measured using the OCT instrument's algorithm
Measured: Day 0 and Day 180
Fundus autofluorescence (FAF)
Blue FAF imaging will be performed to assess variations in lipofuscin autofluorescence
Measured: Day 0 and Day 180
Color Fundus Photography (CFP)
CFP imaging uses a standard retinal camera.
Measured: Day 0 and Day 180
Microperimetry testing
Microperimetry will be tested according to a standard protocol using a Nidek MP-1 instrument
Measured: Day 0 and Day 180
Dark adaptometry
Dark adaptometry will be assessed using a standard protocol.
Measured: Day 0 and Day 180
Plasma microbial metabolites
Biogenic amines will be measures by LC-MS
Measured: Day 0 and Day 180
Plasma lutein and zeaxanthin
Plasma concentrations of lutein and zeaxanthin will be measured by LC-MS
Measured: Day 0 and Day 180
Lipoprotein profile
Lipoprotein profiles will be measured according to standard protocols
Measured: Day 0 and Day 180
HDL particle characteristics
Plasma will also be used to isolate and characterize HDL particles.
Measured: Day 0 and Day 180
Peripheral blood mononuclear cells (PBMC) gene expression changes
PBMCs will be collected to monitor gene expression changes.
Measured: Day 0 and Day 180
Cognitive function
Cognitive function will be assessed using web-based CANTAB tests
Measured: Day 0 and Day 180
Handgrip strength
Handgrip strength will be measured using a Jamar hand dynamometer
Measured: Day 0 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Apr 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Robert M Hackman, PhD, Principal investigator, University of California, DavisAngela M Zivkovic, PhD, Principal investigator, University of California, DavisGlenn Yiu, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237127
- Sponsor's protocol ID
- 2082960
- Acronym
- GOJI
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06237127
- Acronym / sponsor ID
- GOJI / 2082960
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Goji Berry, Age-Related Macular Degeneration, Lutein, Zeaxanthin, Fiber, Carotenoids, Gut Microbiome, HDL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Age-related macular degeneration (AMD) is the third leading cause of blindness worldwide. The disease occurs when the macula in the central retina develops lesions due, in part, to the loss of the protection of macular pigments zeaxanthin, lutein, and meso-zeaxanthin, which are responsible for light filtering and oxidative defense. The major risk factor for AMD is aging, and currently, no definitive prevention for AMD exists.
Goji berry (Lycium Barbarum) is a fruit that has been used as traditional medicine in Asian countries for more than 2,000 years. Modern science has identified potential benefits of the berry in oxidant defense, immune regulation, diabetes, and vision in animal and cell models. Nonetheless, evidence regarding the effects of goji berries on human health is scarce. The bioactive components of goji berries include zeaxanthin, lutein, Lycium Barbarum polysaccharides-protein complex, betaine, cerebroside, minerals, and vitamins. Importantly, goji berries contain the highest concentration of zeaxanthin among all commonly consumed foods.
Previous clinical studies have shown that goji berries have a high bioavailability of zeaxanthin, and that macular pigment optical density (MPOD) was increased after supplementation. This study uses macular pigment optical volume (MPOV; a measure that integrates MPOD across multiple macular eccentricities) as the primary outcome measure. It is unknown if the changes in MPOV will be associated with other functional changes or anatomic conditions in the eye among a population with small drusen, a risk factor for AMD. In addition, the impact of goji berry intake on the gut microbiome profile and associated metabolites is unknown, and potentially important in understanding the mechanism(s) of action.
Participants who meet the eligibility criteria will be enrolled and will be randomized 1:1 to the goji berry arm or fiber arm of the study. Over the course of approximately 180 days, participants will consume the assigned food item five days per week and attend three study visits.
Study visits will include ophthalmic imaging and testing, skin carotenoid measurements, completion of a food record, height, weight, handgrip strength, blood pressure measurement, and fasting blood collection. At 2 timepoints participants will be asked to provide a stool sample (collected within 24 hours of visit).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goji berry | Experimental | Dietary Supplement: Goji berryFor the goji berry arm, participants will consume goji berries. |
| Fiber | Active comparator | Dietary Supplement: FiberFor the fiber arm, participants will consume fiber supplements that closely matches the fiber type and amount found in the portion of goji berries. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Family history of AMD
- Hyperlipidemia or managed diabetes
- 65 - 95 years of age
Key exclusion criteria (13 listed)
- 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
- Use of multi-vitamin or any other supplements that contain lutein and/or zeaxanthin (if willing to stop the supplement, subject can be enrolled 6 months from stop date)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goji berryParticipants will be instructed to consume 14 grams of goji berries 5 days a week for 6 months | Dietary supplement | Goji berry |
| FiberParticipants will be instructed to consume the fiber supplements 5 days a week for 6 months | Dietary supplement | Fiber |
Primary outcome
Macular pigment optical volume (MPOV)
Time frame: Day 0 and Day 180
MPOV provides an objective measure of macular pigments by using dual wavelength autofluorescence using the Heidelberg Spectralis to obtain HRA + OCT measures
13 secondary outcomes
Stool microbiome
Time frame: Day 0 and Day 180
Spectral Domain-Ocular Coherence Tomography (SD-OCT)
Time frame: Day 0 and Day 180
Fundus autofluorescence (FAF)
Time frame: Day 0 and Day 180
Color Fundus Photography (CFP)
Time frame: Day 0 and Day 180
Microperimetry testing
Time frame: Day 0 and Day 180
Dark adaptometry
Time frame: Day 0 and Day 180
Plasma microbial metabolites
Time frame: Day 0 and Day 180
Plasma lutein and zeaxanthin
Time frame: Day 0 and Day 180
Lipoprotein profile
Time frame: Day 0 and Day 180
HDL particle characteristics
Time frame: Day 0 and Day 180
Peripheral blood mononuclear cells (PBMC) gene expression changes
Time frame: Day 0 and Day 180
Cognitive function
Time frame: Day 0 and Day 180
Handgrip strength
Time frame: Day 0 and Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert M Hackman, PhD principal investigator
University of California, Davis
Angela M Zivkovic, PhD principal investigator
University of California, Davis
Glenn Yiu, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goji berry and Fiber in people with Age-Related Macular Degeneration, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Macias, CCRP ((916) 734-6303, dcmacias@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular pigment optical volume (MPOV) (time frame: Day 0 and Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.