Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE)

NCT06848101 | Active Not Recruiting

• 1 other identifier: IRB23-0196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vision; Eye Health

Outcome Measures

Primary Outcomes (1)

• Macular Pigment Optical Density

  Macular carotenoids assessed using heterochromatic flicker photometry

  From enrollment to end of treatment at 4 months

Secondary Outcomes (2)

• Skin carotenoids

  From enrollment to end of treatment at 4 months

• Visual Fatigue

  From enrollment to end of treatment at 4 months

Study Arms (2)

Carotenoid Complex Supplement

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

flaxseed oil (330mg)

Dietary Supplement: Control (placebo) group

Interventions

Carotenoid Group DIETARY_SUPPLEMENT

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)

Carotenoid Complex Supplement

Control (placebo) group DIETARY_SUPPLEMENT

Flaxseed Oil (330mg)

Control

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• not pregnant
• not breastfeeding
• absence of hypertension
• absence of diabetes
• absence of cerebrovascular disease
• absence of cardiovascular disease
• absence of liver disease
• absence of kidney disease
• absence of gastrointestinal disease
• absence of age-related macular degeneration
• no allergy to carotenoids
• /20 or corrected vision
• MPOD less than or equal to 0.60
• Age between 20-45 years

You may not qualify if:

• pregnant
• breastfeeding
• presence of hypertension
• presence of diabetes
• presence of cerebrovascular disease
• presence of cardiovascular disease
• presence of liver disease
• presence of kidney disease
• presence of gastrointestinal disease
• presence of age-related macular degeneration
• allergy to carotenoids
• not 20/20 or uncorrected vision
• MPOD greater than 0.60
• Younger than 20 years or older than 45 years

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Daiken Biomedical Co., Ltd.: collaborator

Study Sites (1)

University of illinois

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: March 15, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)