Effects of Goji vs. Fiber on Macular Degeneration

NCT06237127 | Recruiting

• 1 other identifier: 2082960
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Macular pigment optical volume (MPOV)

  MPOV provides an objective measure of macular pigments by using dual wavelength autofluorescence using the Heidelberg Spectralis to obtain HRA + OCT measures

  Day 0 and Day 180

Secondary Outcomes (13)

• Stool microbiome

  Day 0 and Day 180

• Spectral Domain-Ocular Coherence Tomography (SD-OCT)

  Day 0 and Day 180

• Fundus autofluorescence (FAF)

  Day 0 and Day 180

• Color Fundus Photography (CFP)

  Day 0 and Day 180

• Microperimetry testing

  Day 0 and Day 180

Study Arms (2)

Goji berry

EXPERIMENTAL

For the goji berry arm, participants will consume goji berries.

Dietary Supplement: Goji berry

Fiber

ACTIVE COMPARATOR

For the fiber arm, participants will consume fiber supplements that closely matches the fiber type and amount found in the portion of goji berries.

Dietary Supplement: Fiber

Interventions

Goji berry DIETARY_SUPPLEMENT

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

Goji berry

Fiber DIETARY_SUPPLEMENT

Participants will be instructed to consume the fiber supplements 5 days a week for 6 months

Fiber

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify 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)
• 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

Sponsors & Collaborators

• University of California, Davis: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

UC Davis Eye Center, Tschannen Eye Institute

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert M Hackman, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Angela M Zivkovic, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Glenn Yiu, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Macias, CCRP

CONTACT

(916) 734-6303; dcmacias@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nutritionist

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 1, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)