The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Macular Pigment Optical Density (MPOD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •<.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.
排除标准
- •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.
结局指标
主要结局
Macular Pigment Optical Density (MPOD)
时间窗: 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.
The MPS II will be used to measure MPOD
Bone Density
时间窗: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep.
Cognitive Performance
时间窗: 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
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.
次要结局
- 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.)
研究者
Karen Beathard
Instructional Associate Professor
Texas A&M University