Effects of Goji vs. Fiber on Macular Degeneration (NCT06237127) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Goji vs. Fiber on Macular Degeneration
United States60 participantsStarted 2024-04-29
Plain-language summary
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 can participate
Age range65 Years – 95 Years
SexALL
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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
* An…