Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE) (EyeCARE)

February 24, 2025 updated by: University of Illinois at Urbana-Champaign
The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lutein and zeaxanthin are carotenoids or plant-based pigments that accumulate in various human tissues including the eye, skin, adipose/fat, and the brain where they play important roles as antioxidants and light filters. Previous correlational work has shown that lutein and zeaxanthin intake is associated with multiple markers of health including visual and cognitive outcomes. However, experimental or intervention research examining the effects of lutein and zeaxanthin supplementation on the accumulation of these carotenoids in the eye and skin and implications for visual and cognitive function is still emerging. Additionally, virtually all the previous research has relied on single nutrient supplementation (e.g., only lutein or zeaxanthin) resulting in limited knowledge of the benefits of providing these carotenoids with other possibly healthful nutrients (e.g., astaxanthin, vitamin E). Accordingly, this project will test the effects of lutein and zeaxanthin supplementation provided in a complex with other antioxidants and nutrients on outcomes of nutritional status in the eye and skin as well as visual and cognitive health. The study aims will be addressed using a double-blind randomized controlled trial design. Adults 20-45 years of age will be asked to participate in a daily 4-month double-blind randomized controlled clinical trial. Treatment group (N=20) participants will be asked to consume 2 daily softgels with a daily total containing 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel). Participants will be asked to consume the supplements with a meal of their choosing. Control group participants will be asked to consume similar-looking placebo softgels over the same period.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. not pregnant
  2. not breastfeeding
  3. absence of hypertension
  4. absence of diabetes
  5. absence of cerebrovascular disease
  6. absence of cardiovascular disease
  7. absence of liver disease
  8. absence of kidney disease
  9. absence of gastrointestinal disease
  10. absence of age-related macular degeneration
  11. no allergy to carotenoids
  12. 20/20 or corrected vision
  13. MPOD less than or equal to 0.60
  14. Age between 20-45 years

Exclusion Criteria:

  1. pregnant
  2. breastfeeding
  3. presence of hypertension
  4. presence of diabetes
  5. presence of cerebrovascular disease
  6. presence of cardiovascular disease
  7. presence of liver disease
  8. presence of kidney disease
  9. presence of gastrointestinal disease
  10. presence of age-related macular degeneration
  11. allergy to carotenoids
  12. not 20/20 or uncorrected vision
  13. MPOD greater than 0.60
  14. Younger than 20 years or older than 45 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carotenoid Complex Supplement
20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel)
Dietary supplement: Carotenoid Group
Treatment will contain 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel)
Placebo Comparator: Control
flaxseed oil (330mg)
Dietary supplement: Control (placebo) group
Flaxseed Oil (330mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular Pigment Optical Density
Time Frame: From enrollment to end of treatment at 4 months
Macular carotenoids assessed using heterochromatic flicker photometry
From enrollment to end of treatment at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin carotenoids
Time Frame: From enrollment to end of treatment at 4 months
Carotenoids in skin assessed using skin reflection spectroscopy
From enrollment to end of treatment at 4 months
Visual Fatigue
Time Frame: From enrollment to end of treatment at 4 months
Visual fatigue as assessed by the Computer Vision Syndrome Questionnaire
From enrollment to end of treatment at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Daiken Biomedical Co., Ltd.

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 Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

March 14, 2025

Study Completion (Estimated)

March 14, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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