Clinical trial NCT06489873: Lutein, Zeaxathin, and Fish Oil Supplementation
Official title: The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Allen Foundation Inc.
First posted: 2024-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to an LZF or placebo supplement group and asked to take the assigned supplement daily for six months.
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* \<.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.

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.

Primary outcomes:
measure: Macular Pigment Optical Density (MPOD)
timeFrame: 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.
measure: Cognitive Performance
timeFrame: 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
measure: Bone Density
timeFrame: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
Secondary outcomes:
measure: Lutein and Zeaxanthin Serum Levels
timeFrame: Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
Other outcomes:
Locations:
city: College Station
country: United States
facility: Gilchrist Building
state: Texas
Study officials:
affiliation: Texas A&M University
name: Karen M Beathard, PhD
role: PRINCIPAL_INVESTIGATOR
References: