RECRUITINGINTERVENTIONAL
Effects of Goji vs. Fiber on Macular Degeneration
Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical Trial
About This 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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Family history of AMD
- Hyperlipidemia or managed diabetes
- 65 - 95 years of age
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIETARY_SUPPLEMENT
Goji berry
Participants will be instructed to consume 14 grams of goji berries 5 days a week for 6 months
DIETARY_SUPPLEMENT
Fiber
Participants will be instructed to consume the fiber supplements 5 days a week for 6 months
Locations (1)
UC Davis Eye Center, Tschannen Eye Institute
Sacramento, California, United States