Effects of Goji Berries on Age-Related Macular Degeneration
Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical Trial
This study is testing whether eating goji berries can help improve eye health in people aged 50 to 95 who are at risk for age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years to 95 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06237127 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of goji berry intake compared to fiber on visual health in participants aged 50 to 95 who are at risk for age-related macular degeneration (AMD). Over six months, participants will consume either 28g of goji berries or an equivalent amount of fiber five days a week. The study will assess changes in macular pigment optical volume, gut microbiome profiles, skin carotenoid levels, and lipoprotein profiles. The research seeks to explore the potential benefits of goji berries, which are rich in zeaxanthin and lutein, on AMD progression.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 95 with a diagnosis of small drusen and at risk for age-related macular degeneration.
Not a fit: Patients with allergies to goji berries or the ingredients in the fiber treatments, or those consuming certain medications or supplements, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that may help prevent or slow the progression of age-related macular degeneration.
How similar studies have performed: Previous studies have indicated that goji berries may improve macular pigment density, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Family history of AMD * Hyperlipidemia or managed diabetes * 65 - 95 years of age Exclusion Criteria: * 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) * 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
Where this trial is running
Sacramento, California
- UC Davis Eye Center, Tschannen Eye Institute — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Robert M Hackman, PhD — University of California, Davis
- Study coordinator: Denise Macias, CCRP
- Email: dcmacias@ucdavis.edu
- Phone: (916) 734-6303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.