Goji Berries vs. Fiber for Age-Related Macular Degeneration

(GOJI Trial)

Overseen By Denise Macias, CCRP

Age: 18+

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

Trial Summary

What is the purpose of this trial?

The goal of this project is to conduct a clinical trial in 60 participants ranging from age 50-95 with small drusen who are at risk for age-related macular degeneration (AMD). The study will evaluate the effects of 28g 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.

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.

What data supports the effectiveness of the treatment Goji Berries for age-related macular degeneration?

Research shows that regular intake of Goji berries can increase macular pigment optical density, which is a measure that helps protect the eyes and may prevent or delay age-related macular degeneration. ^{1 2 3 4 5}

Is it safe to consume goji berries for age-related macular degeneration?

Goji berries have been studied for their effects on eye health, and no adverse events were reported in human studies. Additionally, animal studies showed no harmful effects on liver or kidney tissues, suggesting that goji berries are generally safe for consumption. ^{1 4 6 7 8}

How is the Goji berry treatment different from other treatments for age-related macular degeneration?

The Goji berry treatment is unique because it focuses on increasing macular pigment and serum zeaxanthin levels, which are important for protecting the eyes from blue light and oxidative damage. Unlike other treatments, it involves consuming a natural food source rich in antioxidants, particularly zeaxanthin, which may help prevent or delay the progression of age-related macular degeneration. ^{1 4 6 9 10}

Research Team

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Macular pigment and serum zeaxanthin levels with Goji berry supplement in early age-related macular degeneration. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Dietary flavonoids are associated with longitudinal treatment outcomes in neovascular age-related macular degeneration. [2021]

3. England 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. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Goji Berry Intake Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Pilot Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of fish and shellfish consumption on age-related macular degeneration. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Goji berry effects on macular characteristics and plasma antioxidant levels. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration. [2022]

8. Greece pubmed.ncbi.nlm.nih.gov

Effects of Lycium barbarum (goji berry) on dry eye disease in rats. [2022]

9. New Zealand 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. [2022]

10. United States 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]