Nutrition, Vision, and Cognition in Sport Study: Beef
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean NeuroTracker Speed Threshold over 300 trials
研究概览
简要总结
The purpose of this study is to determine whether a 30 day beef intervention can improve peak cognitive performance in young, normally menstruating adult women. The control group will consume a daily portion of macronutrient equivalent vegetable source of protein.
详细描述
The purpose of the Nutrition, Vision, and Cognition in Health Sport: Beef (IONSport-Beef) study is to conduct a randomized controlled trial to evaluate beef as a nutritional intervention to optimize visual cognitive training performance in generally healthy, normally menstruating women. Female subjects of reproductive age (18-40) will be randomly placed in one of two dietary treatment groups: one serving of beef per day for 30 days or a non-meat protein replacement control. Cognitive performance will be measured in 15 training sessions over 10 days using the sophisticated NeuroTracker™ CORE (NT) 3-Dimensional (3D) software program. It is hypothesized that women consuming 1 serving of beef per day for 30 days will have the highest plasma levels of the beef rich nutrients and demonstrate the highest visual cognitive performance and improvement as compared to the no beef control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
note on masking: The title of the study presented to participants is "IONsport: Women and Protein" and the funding source is withheld to mask from participants our underlying hypothesis. It is open label in the sense that they know what they are eating.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-40 year old female
- •Eumenorrheic
排除标准
- •Neuroactive medications such as Ritalin, Adderall, antidepressants etc
- •Dietary supplements
- •Iron intake above 15mg/day
- •Protein intake above 1.5 g/kg/day
- •More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months
- •History of affective disorder
- •Visual impairments uncorrected by glasses
- •Amenorrhea or dysmenorrhea
- •Currently being treated for anemia
- •>3 servings of beef per week
- •<20 BMI or BMI >35
- •Consume >100mg caffeine/day (>1 cup of coffee or soda)
- •<1 hour/week physical activity, >4 hours/week vigorous activity
- •Depression score >18 (Beck Depression Inventory)
- •<20 Kcal/kg/day
结局指标
主要结局
Mean NeuroTracker Speed Threshold over 300 trials
时间窗: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful.The speed threshold is optimized performance for that session. Across the 15 sessions, mean speed threshold is defined as the average speed threshold for the 15 sessions.
Maximal NeuroTracker Speed Threshold over 300 trials
时间窗: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful. The speed threshold is optimized performance for that session. Across the 15 sessions, maximal speed threshold is defined as the highest speed threshold.
Change in NeuroTracker Speed Threshold over 300 trials
时间窗: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful. The speed threshold is optimized performance for that session. Across the 15 sessions, change in speed threshold is defined as the difference between the mean of the first three sessions and the mean of the last three sessions.
次要结局
- Blood Markers of anemia(Day 1 and Day 30 of the intervention)
研究者
Steven E.Riechman, PhD, MPH
Associate Professor
Texas A&M University