RecruitingNot ApplicableNCT06237127

Effects of Goji vs. Fiber on Macular Degeneration

Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical Trial


Sponsor

University of California, Davis

Enrollment

60 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 YearsMax Age: 95 Years

Inclusion Criteria3

  • Family history of AMD
  • Hyperlipidemia or managed diabetes
  • - 95 years of age

Exclusion Criteria13

  • 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

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Interventions

DIETARY_SUPPLEMENTGoji berry

Participants will be instructed to consume 14 grams of goji berries 5 days a week for 6 months

DIETARY_SUPPLEMENTFiber

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

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NCT06237127


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