RECRUITING

Effects of Goji vs. Fiber on Macular Degeneration

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Conditions

Age-Related Macular DegenerationGoji BerryLuteinZeaxanthinFiberCarotenoidsGut MicrobiomeHDLCholesterol Efflux CapacityEye Health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-29
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06237127

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.

Ages Eligible for Study:65 Years to 95 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Family history of AMD
  2. * Hyperlipidemia or managed diabetes
  3. * 65 - 95 years of age
  1. * 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)
  2. * Consumption of \> 2 alcoholic drinks per day
  3. * Indications of substance or alcohol abuse
  4. * Current or planned use of a blood thinner (e.g., Coumadin, Warfarin) at any time during study
  5. * 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)
  6. * 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)
  7. * Any planned international travel during the study
  8. * Consuming \>3 servings/day of a combination of spinach, kale, lettuce, orange bell peppers, corn, parsley, squash, broccoli, pumpkin, edamame
  9. * Regularly consuming \>3 eggs/day
  10. * Currently participating in any other interventional research study
  11. * 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
  12. * Any physical characteristic or condition that precludes ability to perform study procedures
  13. * Medical or psychiatric condition that, in the opinion of the Investigator, would compromise study findings or prevent the participant from completing the study

Contacts and Locations

Study Contact

Denise Macias, CCRP
CONTACT
(916) 734-6303
dcmacias@ucdavis.edu

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Age-Related Macular Degeneration