Summary

Eligibility
for people ages 50-80 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around
Principal Investigator
by Robert M Hackman, PhD (ucdavis)Glenn Yiu, MD, PhD (ucdavis)

Description

Summary

The goal of this project is to conduct a clinical trial in 60 participants ranging from age 50-80 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..

Official Title

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

Keywords

Age-Related Macular Degeneration, Goji Berry, Lutein, Zeaxanthin, Fiber, Carotenoids, Gut Microbiome, HDL, Cholesterol Efflux Capacity, Eye Health, Macular Degeneration

Eligibility

You can join if…

Open to people ages 50-80

  • Diagnosis of small drusen by a retinal specialist
  • Willingness and ability to comply with the study protocol
  • 50 - 80 years of age

You CAN'T join if...

  • 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

Lead Scientists at University of California Health

  • Robert M Hackman, PhD (ucdavis)
    Researcher, Nutrition, College of Agricultural and Environmental Sciences. Authored (or co-authored) 34 research publications
  • Glenn Yiu, MD, PhD (ucdavis)
    Associate Professor, Ophthalmology, School of Medicine. Authored (or co-authored) 116 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06237127
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated