Goji Berries vs. Fiber for Age-Related Macular Degeneration
(GOJI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must not be taking: Blood thinners
Disqualifiers: Alcohol abuse, Gastrointestinal disorder, others
No Placebo Group
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.
12345Is 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.
14678How 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.
146910Eligibility 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
+10 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis Eye Center, Tschannen Eye InstituteSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
United States Department of Agriculture (USDA)Collaborator
References
Macular pigment and serum zeaxanthin levels with Goji berry supplement in early age-related macular degeneration. [2020]To evaluate the efficacy of Goji berry supplementation on improving macular pigment, serum zeaxanthin levels and visual acuity in patients with early age-related macular degeneration (AMD).
Dietary flavonoids are associated with longitudinal treatment outcomes in neovascular age-related macular degeneration. [2021]To assess whether dietary intake of flavonoids are associated with longitudinal treatment outcomes of patients with neovascular age-related macular degeneration (nAMD).
Dietary antioxidants are associated with presence of intra- and sub-retinal fluid in neovascular age-related macular degeneration after 1 year. [2021]To assess whether dietary intake of antioxidants, fruits, vegetables and fish is associated with 12-month treatment outcomes in neovascular age-related macular degeneration (nAMD) patients.
Goji Berry Intake Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Pilot Trial. [2022]Age-related macular degeneration (AMD) is the third leading cause of blindness worldwide. Macular pigment optical density (MPOD), a biomarker for AMD, is a non-invasive measure to assess risk. The macula xanthophyll pigments lutein (L) and zeaxanthin (Z) protect against blue light and provide oxidant defense, which can be indexed by MPOD. This study examined the effects of Z-rich goji berry intake on MPOD and skin carotenoids in healthy individuals. A randomized, unmasked, parallel-arm study was conducted with 27 participants, aged 45-65, who consumed either 28 g of goji berries or a supplement containing 6 mg L and 4 mg Z (LZ), five times weekly for 90 days. After 90 days, MPOD was significantly increased in the goji berry group at 0.25 and 1.75 retinal eccentricities (p = 0.029 and p = 0.044, respectively), while no changes were noted in the LZ group. Skin carotenoids were significantly increased in the goji berry group at day 45 (p = 0.025) and day 90 (p = 0.006), but not in the LZ group. Regular intake of goji berries in a healthy middle-aged population increases MPOD may help prevent or delay the development of AMD.
The impact of fish and shellfish consumption on age-related macular degeneration. [2021]To determine the relationship between fish and shellfish consumption and age-related macular degeneration (AMD) status in the Salisbury Eye Evaluation (SEE) Study participants.
Goji berry effects on macular characteristics and plasma antioxidant levels. [2014]Goji berry (Lycium barbarum L.) is purported to benefit vision because of its high antioxidant (especially zeaxanthin) content, although this effect has not been demonstrated in high-quality human studies. The purpose of this study was to evaluate the effects of daily supplementation with a proprietary milk-based formulation of goji berry, Lacto-Wolfberry (LWB), on macular characteristics and plasma zeaxanthin and antioxidant capacity levels in elderly subjects.
An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration. [2022]Age-related macular degeneration (AMD) is one of the most widespread degenerative disorders in elderly people. A 90-day, open-label clinical study was conducted in 40 patients, aged 50 years or older, with early-stage dry-type AMD to evaluate the safety and efficacy of Macumax®, a novel mixture of a phyto-mineral nutritional supplement containing ZeaLutein® (consisting of lutein, zeaxanthin, and piperine), extracts of bilberry, saffron, and zinc monomethionine. Subjects received one capsule of the supplement twice daily for 90 days. The treatment measures included physical examination, vital signs, and assessment of subjective and objective symptoms at baseline and after treatment. For efficacy assessment, baseline values were compared with the values after treatment at 30-day intervals, on days 30, 60, and 90. The safety of the treatment was assessed during all the visits. Overall, the patients showed improvement in the subjective symptoms, such as vision scores after treatment compared with baseline. The changes in diminished and distorted vision scores were found to be significant from day 60 (P < .05). In the case of objective symptoms, only 40% of the subjects (P < .05) had abnormal Amsler's grid aberration scores on day 90 compared with 77.5% of subjects at the beginning of the study. No adverse events were observed during the study. This pilot study provides evidence that Macumax® supplementation is safe and maintained eye health without further progression of the disease in patients with early-stage dry-type AMD. Clinical Trial Registration number: CTRI/2016/02/006676.
Effects of Lycium barbarum (goji berry) on dry eye disease in rats. [2022]Lycium barbarum (goji berry) has long been used as a food and traditional herbal medicine. This study aimed to investigate the beneficial effect of the goji berry on dry eye disease in rats. Male Sprague‑Dawley rats with induced dry eye disease were randomly assigned to four groups: Vehicle (control), low‑dose goji berry extract [GBE; 250 mg/kg/body weight (bw)], median‑dose GBE (350 mg/kg/bw), and high‑dose GBE (500 mg/kg/bw). Three methods, Schirmer's test, tear break‑up time (BUT) measurement and keratoconjunctival fluorescein staining, were used to evaluate the effect of GBE on symptoms of dry eye disease experienced by the rats. The results of the present study revealed that both the Schirmer's test score and tear BUT significantly increased following 1 week of GBE administration. Furthermore, the severity of the keratoconjunctival staining decreased significantly. In addition, the results suggested that administration of GBE may ameliorate dry eye disease symptoms in a dose‑dependent manner. There were no mortalities and no apparent abnormal histopathology changes in the liver or kidney tissues of rats administered GBE for 21 consecutive days. Polysaccharides and betaine present in GBE may have important effects in alleviating dry eye disease induced by oxidative stress and inflammation. In conclusion, the goji berry is a safe, functional food with beneficial effects in alleviating dry eye disease.
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]Label="PURPOSE" NlmCategory="OBJECTIVE">The aim of this study was to observe the mechanism of Fructus Lycii (FL), Rehmanniae Radix Praeparata (RRP) and Paeonia lactiflora (PL) in treating age-related macular degeneration (AMD) based on network pharmacology and biological experiments.
Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. [2022]Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further reduce this risk.