Lutein, Zeaxathin, and Fish Oil Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD \<.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.

Healthy adults ages 18-45 years with MPOD \<.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.

Conditions

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Cognitive Performance Age-Related Macular Degeneration Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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LZF Supplement

Participants will take one LZF supplement daily for six months.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants will take on placebo supplement daily for six months.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes