Lutein, Zeaxathin, and Fish Oil Supplementation

NCT06489873 | Recruiting

• 1 other identifier: 2024-0035
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults. The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months? Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation. Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density. Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

Conditions

Cognitive Performance; Age-Related Macular Degeneration; Bone Loss

Keywords

Lutein; Zeaxanthin; Fish Oil; Supplement; Macular Pigment; Macular Pigment Optical Density; Cognition; Age-related Macular Degeneration; Cognitive Performance

Outcome Measures

Primary Outcomes (3)

• Macular Pigment Optical Density (MPOD)

  The MPS II will be used to measure MPOD

  MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.

• Cognitive Performance

  Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold.

  Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study

• Bone Density

  The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.

  Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.

Secondary Outcomes (1)

• Lutein and Zeaxanthin Serum Levels

  Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.

Study Arms (2)

LZF Supplement

ACTIVE COMPARATOR

Participants will take one LZF supplement daily for six months.

Dietary Supplement: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)

Placebo

PLACEBO COMPARATOR

Participants will take on placebo supplement daily for six months.

Dietary Supplement: Placebo Comparator

Interventions

Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF) DIETARY_SUPPLEMENT

Each participant will be assigned to t a LZF supplement daily for six months

LZF Supplement

Placebo Comparator DIETARY_SUPPLEMENT

Each participant will be assigned to take a placebo supplement daily for six months

Placebo

Eligibility Criteria

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

You may not qualify if:

• allergic to lutein, zeaxanthin, or fish oil, taking supplements with \>6 mg lutein and/or \>2 mg zeaxanthin for more than two months before study starts, MPOD between \>.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.

Sponsors & Collaborators

• Texas A&M University: lead
• Allen Foundation Inc.: collaborator

Study Sites (1)

Gilchrist Building

College Station, Texas, 77843, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Bone Diseases, Metabolic

Interventions

Lutein; Zeaxanthins

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Karen M Beathard, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Beathard, PhD

CONTACT

979-220-2281; karen-beathard@tamu.edu

Steven E Riechman, PhD

CONTACT

979-862-3213; sriechman@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher not participating in the research randomized participants and packaged LZF and placebo supplements in the exact same bottle other than the participant number and delivered these to the PI for distribution. Only this person has the list of numbers associated with the supplements.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructional Associate Professor

Model Details: Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: February 7, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)