Effects of Goji vs. Fiber on Macular Degeneration
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 Start (Actual) 29 April 2024
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Diagnosis of small drusen by a retinal specialist
    • * Willingness and ability to comply with the study protocol
    • * 50 - 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
    • * 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 (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 19 January 2024
  • First Submitted that Met QC Criteria 24 January 2024
  • First Posted 1 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 May 2024
  • Last Update Posted 10 May 2024
  • Last Verified May 2024