Lutein, Zeaxathin, and Fish Oil Supplementation

Texas A&M University

Status: Enrolling

Conditions: Age-Related Macular Degeneration; Cognitive Performance; Bone Loss

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06489873

2024-0035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups, including a placebo group

LZF Supplement

Active Comparator group

Description:

Participants will take one LZF supplement daily for six months.

Treatment:

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

Placebo

Placebo Comparator group

Description:

Participants will take on placebo supplement daily for six months.

Treatment:

Dietary Supplement: Placebo Comparator