Goji Berries vs. Fiber for Age-Related Macular Degeneration

(GOJI Trial)

Overseen By Denise Macias, CCRP

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Blood thinners

Disqualifiers: Alcohol abuse, Gastrointestinal disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how goji berries and fiber may aid in age-related macular degeneration (AMD), a common eye condition in older adults. Researchers aim to determine if consuming goji berries or a similar amount of fiber for six months can enhance visual health and other functions, such as gut health. Individuals with a family history of AMD and conditions like high cholesterol or controlled diabetes may be suitable for this study. Participants must regularly consume either goji berries or fiber supplements and avoid certain foods and supplements during the trial. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research on natural dietary interventions for AMD.

Will I have to stop taking my current medications?

The trial requires that you do not start any new medications or change your current medication regimen within 6 months before and during the study. If you are taking blood thinners or supplements with lutein or zeaxanthin, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that regularly eating goji berries is generally safe and may benefit health. Studies have found that goji berries can improve eye health in middle-aged people without causing major side effects. They also help protect the eyes, potentially delaying conditions like age-related macular degeneration (AMD).

For the fiber supplement, specific information from the sources provided is lacking. However, fiber is a common dietary component and is usually safe for most people. It is well-tolerated and often recommended for good digestion.

Both goji berries and fiber are natural foods that are typically safe when consumed in recommended amounts. It is important to consult a healthcare provider before starting any new supplement, especially in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for age-related macular degeneration, which often involve injections or laser therapy, goji berries offer a natural dietary approach. Researchers are excited because goji berries are packed with antioxidants like zeaxanthin, believed to support eye health by protecting retinal cells. Fiber supplements, by contrast, are being studied as a comparator to see how they stack up against these potent berries. The unique angle here is exploring whether a simple dietary change can deliver benefits comparable to more conventional therapies.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that regularly eating goji berries can benefit eye health. Studies have found that goji berries help increase a protective layer in the eye, potentially preventing or slowing age-related vision problems. One study found that people who ate goji berries daily had better eye protection and slower progression of these vision issues. This benefit likely arises from goji berries raising levels of zeaxanthin, an antioxidant that supports eye health. In this trial, one group of participants will consume goji berries, while another group will consume fiber supplements. Although fiber supplements aid digestion, less evidence supports their effect on age-related vision problems. ^{1 2 6 7 8}

Who Is on the Research Team?

Glenn Yiu, MD, PhD

Principal Investigator

University of California, Davis

Robert M Hackman, PhD

Principal Investigator

University of California, Davis

Angela M Zivkovic, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and able to follow the study's requirements.

I am between 50 and 95 years old.

Diagnosis of small drusen by a retinal specialist

Exclusion Criteria

Medical or psychiatric condition that, in the opinion of the Investigator, would compromise study findings or prevent the participant from completing the study

I am willing to stop taking supplements with lutein/zeaxanthin for 6 months.

Regularly consuming more than 3 eggs/day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 28g of goji berries or an equivalent amount of fiber, five days a week for six months

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fiber
• Goji berry

Trial Overview

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.

How Is the Trial Designed?

Group I: Goji berry Experimental Treatment 1 Intervention

For the goji berry arm, participants will consume goji berries.

Group II: Fiber Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Published Research Related to This Trial

In a 90-day study involving 40 patients with early-stage dry-type age-related macular degeneration (AMD), the nutritional supplement Macumax® showed significant improvement in subjective vision scores, particularly from day 60 onwards.

The treatment was found to be safe, with no adverse events reported, and it helped maintain eye health by reducing the percentage of patients with abnormal Amsler's grid scores from 77.5% at baseline to 40% by day 90.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration. Majeed, M., Majeed, S., Nagabhushanam, K.[2022]

The Age-Related Eye Disease Study 2 (AREDS2) found that adding lutein + zeaxanthin or DHA + EPA to the original AREDS formulation did not significantly reduce the risk of progression to advanced age-related macular degeneration (AMD) in a study of 4203 participants over a median follow-up of 5 years.

Eliminating beta carotene from the AREDS formulation was associated with a higher incidence of lung cancer in former smokers, suggesting that lutein + zeaxanthin could be a safer alternative in the formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. [2022]

In a study of 114 patients with early age-related macular degeneration (AMD), daily supplementation with 25 g of Goji berries for 90 days significantly increased serum zeaxanthin levels and improved macular pigment optical density (MPOD).

The results suggest that Goji berry supplementation may be an effective way to enhance visual health in early AMD patients, potentially helping to prevent disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular pigment and serum zeaxanthin levels with Goji berry supplement in early age-related macular degeneration. Li, S., Liu, N., Lin, L., et al.[2020]

The study identified 59 active compounds and 182 potential targets from Fructus Lycii, Rehmanniae Radix Praeparata, and Paeonia lactiflora, which are linked to treating age-related macular degeneration (AMD) by reducing oxidative stress and apoptosis in retinal pigment epithelial (RPE) cells.

Experimental results showed that these herbs significantly increased cell viability and decreased apoptosis in ARPE-19 cells exposed to oxidative stress, indicating their potential efficacy in protecting against AMD-related damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of the Effect and Mechanism of Fructus Lycii, Rehmanniae Radix Praeparata, and Paeonia lactiflora in the Treatment of AMD Based on Network Pharmacology and in vitro Experimental Verification. Chen, X., Zuo, J., Hu, T., et al.[2022]

In a study of 547 patients with neovascular age-related macular degeneration (nAMD), those with higher dietary intake of flavonoids, particularly flavonols and flavan-3-ols, showed better visual acuity and lower risk of intra-retinal fluid (IRF) after 12 months of anti-VEGF therapy.

Participants in the lowest tertile of flavonoid intake had significantly worse vision and a twofold higher risk of IRF compared to those in the highest tertile, suggesting that dietary flavonoids may enhance treatment outcomes for nAMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary flavonoids are associated with longitudinal treatment outcomes in neovascular age-related macular degeneration. Detaram, HD., Liew, G., Lewis, JR., et al.[2021]

Daily supplementation with a goji berry formulation (Lacto-Wolfberry) for 90 days significantly increased plasma zeaxanthin levels by 26% and total antioxidant capacity by 57% in healthy elderly subjects, indicating its potential efficacy in enhancing antioxidant levels.

The Lacto-Wolfberry group showed stability in macular pigmentation and soft drusen count, while the placebo group experienced hypopigmentation and drusen accumulation, suggesting a protective effect of the goji berry supplement without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goji berry effects on macular characteristics and plasma antioxidant levels. Bucheli, P., Vidal, K., Shen, L., et al.[2014]

In a study involving male Sprague-Dawley rats with induced dry eye disease, administration of goji berry extract (GBE) significantly improved symptoms, as shown by increased tear production and tear break-up time after one week of treatment.

The study found that GBE is safe for use, with no observed adverse effects on liver or kidney tissues, and its beneficial effects on dry eye disease may be linked to its polysaccharides and betaine content, which help reduce oxidative stress and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Lycium barbarum (goji berry) on dry eye disease in rats. Chien, KJ., Horng, CT., Huang, YS., et al.[2022]

In a study of 494 patients with neovascular age-related macular degeneration (nAMD) followed for 12 months, higher dietary zinc intake was linked to a 49% reduced likelihood of sub-retinal fluid (SRF) presence, suggesting a protective effect against this complication.

Conversely, higher dietary intake of β-carotene was associated with nearly double the odds of intra-retinal fluid (IRF) and pigment epithelial detachment (PED), indicating that certain dietary components may increase risks for specific conditions in nAMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary antioxidants are associated with presence of intra- and sub-retinal fluid in neovascular age-related macular degeneration after 1 year. Dharamdasani Detaram, H., Liew, G., Russell, J., et al.[2021]

In a study of 2520 older adults, there was no significant difference in fish and shellfish consumption among those with different stages of age-related macular degeneration (AMD) compared to controls.

However, individuals with advanced AMD were significantly less likely to consume fish and shellfish high in omega-3 fatty acids, suggesting that higher omega-3 intake may have a protective effect against the progression of AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of fish and shellfish consumption on age-related macular degeneration. Swenor, BK., Bressler, S., Caulfield, L., et al.[2021]

In a study of 27 healthy participants aged 45-65, consuming goji berries for 90 days significantly increased macular pigment optical density (MPOD), a biomarker associated with reduced risk of age-related macular degeneration (AMD).

The goji berry group also showed increased skin carotenoids, indicating enhanced antioxidant levels, while no significant changes were observed in participants taking a lutein and zeaxanthin supplement, suggesting that goji berries may be more effective in promoting eye health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goji Berry Intake Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Pilot Trial. Li, X., Holt, RR., Keen, CL., et al.[2022]

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