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临床试验/NCT06465888
NCT06465888已完成不适用

Evaluating the Influence of Egg Nutrients on Visual Cognitive Performance in Older Adults: A Randomized Controlled Trial

Texas A&M University2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Cognitive performance

研究概览

简要总结

This clinical trial aims to evaluate the nutrients in eggs in healthy adult's cognitive performance. The main questions it aims to answer are:

  • How do the nutrients in eggs impact visual cognitive performance (VCP) in generally healthy older individuals?
  • Will omega-3 fatty acids in eggs improve VCP in generally healthy older individuals?

Participants will be randomly placed in one of five dietary treatment groups, including four egg whites, two whole regular eggs, two whole omega-3 fortified eggs, four egg yolks, and a no-egg control. Blood will be drawn at baseline. During the first two weeks, participants will eat assigned eggs, consume their usual diet other than the eggs, and keep five food logs. Cognitive performance testing will start on day 15 and be measured over a 10-day period using the Neurotracker (NT) 3-D program. Data on ancillary factors influencing outcomes will be collected, and food will be logged on each NT training day. Blood will be drawn at the end of the study and compared with baseline levels.

详细描述

Generally, healthy males or 2 years post-menopausal females between 50 and 75 years old will be recruited for this study. Potential subjects will communicate interest to researchers, and a standardized email with a consent form will be sent to persons of interest. Prospective participants will complete a preliminary questionnaire evaluating visual health to confirm inclusion criteria met, a study ID will be assigned. subjects will be randomly placed in a control group or one of four intervention groups: four egg whites, two whole regular eggs, two whole omega-3 eggs, and four egg yolks. Eggs will be provided to subjects based on their treatment groups; egg distribution will occur on days 1 and 15. Fifteen days of food logs, five days during the first 14 days of the study, and ten days of food logs each day the subjects train on the Neurotracker software. Food logs will be analyzed using Nutribase software.

Two weeks after the commencement of the study (Day 15), cognitive performance testing will begin. This testing will be conducted over a 10-day period, consisting of 15 training sessions. The Neurotracker (NT) 3-D program will be used for these sessions. On each NT training day, a daily data questionnaire will be used to collect data on ancillary factors that may influence the outcomes of the study.

Blood will be drawn at baseline, on day 15, and at the end of the study. Average nutrient intake and dietary patterns, baseline plasma draws, rate of change, and maximal performance on the NT software will be examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Participant)

盲法说明

Brand name of eggs on cartons will be covered so participants will not know which eggs they were eating.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and post-menopausal women who are age 50 to 75 years

排除标准

  • Taking supplements with >6 mg L and/or >2 mg Z two months before the study
  • Self-reported diagnosis of age-related macular degeneration, diabetic retinopathy, glaucoma, or other eye conditions that may negatively impact visual cognitive performance

结局指标

主要结局

Cognitive performance

时间窗: 15 cognitive sessions within 10 days over 2 week period

Neurotracker 3-Dimensional software used to measure cognitive performance. Subjects performed 20 trials within a single training session obtaining a "speed threshold," (ST) the level at which the participant correctly tracked and selected the correct objects 50% of the time. The final ST for each training session and the progression over 15 sessions were the primary determinants of cognitive performance.

Nutrient Intake (Lutein and Zeaxanthin)

时间窗: Through study completion which may take up to 2 years.

Serum will be drawn and analyzed for lutein and zeaxanthin content

次要结局

  • Serum Lipid Levels(Through study completion which may take up to 2 years.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven E.Riechman, PhD, MPH

Associate Professor

Texas A&M University

研究点 (2)

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