Effects of Goji vs. Fiber on Macular Degeneration

Description

The goal of this project is to conduct a clinical trial in 60 participants ranging from age 50-95 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.

Conditions

Age-Related Macular Degeneration

Study Overview

Study Details

Study overview

The goal of this project is to conduct a clinical trial in 60 participants ranging from age 50-95 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.

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

Effects of Goji vs. Fiber on Macular Degeneration

Condition
Age-Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Sacramento

UC Davis Eye Center, Tschannen Eye Institute, Sacramento, California, United States, 95817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of small drusen by a retinal specialist
  • * Willingness and ability to comply with the study protocol
  • * 50 - 95 years of age
  • * 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

Ages Eligible for Study

50 Years to 95 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, Davis,

Robert M Hackman, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Angela M Zivkovic, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Glenn Yiu, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

2027-06-30