Effects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury After Exercise in the Heat
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Urine Biomarker of Acute Kidney Injury Risk from Creatine Use Prior to Exercise in the Heat (The mathematical product of IGBFP7 and TIMP-2 [IGFBP7 x TIMP-2; NephroCheck®])
研究概览
简要总结
The goal of this clinical trial is to learn if one week of creatine monohydrate supplementation alters inflammation, markers of acute kidney injury (AKI) risk, and cognitive performance in active, young, healthy volunteers. The main questions it aims to answer are:
- Does one-week of creatine supplementation alter urinary markers of inflammation (cytokines) during exercise in the heat when compared to placebo?
- Does one-week of creatine supplementation alter markers of AKI during exercise in the heat when compared to placebo?
- Does one-week of creatine supplementation attenuate reductions in cognitive measures as a response of fatigue from exertional heat stress.
Researchers will compare creatine monohydrate to a placebo (maltodextrin) to see if it alters inflammation, risk of acute kidney injury, and cognition after exercise in the heat.
Participants will :
- Complete a baseline aerobic exercise test to measure VO2max
- Ingest 20 grams per day of creatine monohydrate or placebo (maltodextrin) for seven consecutive days
- Cycle for 90 minutes in a heated chamber (38 C, ~40% relative humidity), alternating low- and high-intensity exercise
- Self-collect urine before, after, and one-hour after exercise
- Self-insert a rectal thermistor to measure core temperature
- Complete cognitive tasks using the NIH toolbox before and after exercise to assess cognition
- Complete the other condition (placebo or creatine) at least 21 days later
详细描述
The outlined research questions/ hypotheses will require 3 visits (1 baseline, then 2 experimental trials) to the UNI Exercise Physiology Lab.
The first (baseline) visit will involve completing paperwork (informed consent, health history questionnaire, physical activity readiness questionnaire; PAR-Q+), familiarization of cognitive assessment techniques, anthropometric assessments, and a maximal effort, graded exercise test.
Baseline Visit:
- Height and weight will be measured using a standing stadiometer and InBody bioimpedance analyses full body analyzer
- Baseline/ Familiarization Cognitive Test: The NIH Toolbox Fluid Cognition Battery and Color Word Stroop Test (CWST) will be administered for baseline cognitive values and familiarization. This will be administered via iPad in a quiet room with minimal distractions
- Cycle Ergometer Test: Aerobic fitness will be assessed using a graded, maximal oxygen consumption test on a cycle ergometer. Subjects will be given a nose clip and mouthpiece which will be connected to a metabolic cart. Heart rate response and gas exchange will be monitored throughout the test.
- Identification of workloads used for experimental trials: Following the cycle ergometer test, participants will rest in a seated position for 10-minutes. They will then undergo a series of 3-minutes submaximal stages to identify workloads which correspond to an estimated metabolic rate of 4 Watts/ kilogram of body weight (4 W/kg) and 8 W/kg. Watts will be estimated via measuring gas exchange (VO2 and Respiratory exchange ratio). These intensities were chosen as they were the average and peak rates which have been observed in a sample of construction workers during work in the summer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Age range: 18-45 years old
- •Physical Activity Level: Classified as 'active' using the criteria of engaging in planned exercise at least 3x/week, for a minimum of 30 minutes per session, over the past 3 months
- •Aerobic Fitness Level: Subjects must have an aerobic fitness classification of at least 'good' per American College of Sports Medicine (ACSM) criteria and assessed via maximal oxygen uptake test
- •Health Status: Free of any known cardiovascular, metabolic, renal, or neurologic conditions.
- •Physical Limitations: Indicates no physical limitations to cycling for ~ 90 minutes
- •Supplementation: Reports no use of creatine within the past 4 weeks
- •Recent Illness: Reports no presence of illness, vomiting, or diarrhea in the previous three days.
排除标准
- •Known allergy to creatine or maltodextrin.
- •History of adverse heat-related events (e.g., heat exhaustion, heat stroke, severe dehydration requiring medical intervention)
- •Reports use of medications or supplements that may interfere with thermoregulation, heart rate, kidney injury or blood pressure responses during exercise (e.g. NSAID)
研究组 & 干预措施
Creatine Monohydrate
Participants will ingest 20 grams per day of creatine monohydrate for 7 days, then 1 day of 5 grams before the exertional heat trial.
干预措施: Creatine Monohydrate (Dietary Supplement)
Placebo (Maltodextrin)
Participants will ingest 20 grams per day of maltodextrin for 7 days, then 1 day of 5 grams before the exertional heat trial.
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
结局指标
主要结局
Change in Urine Biomarker of Acute Kidney Injury Risk from Creatine Use Prior to Exercise in the Heat (The mathematical product of IGBFP7 and TIMP-2 [IGFBP7 x TIMP-2; NephroCheck®])
时间窗: Change in urinary IGBP7 x TIMP-2 from immediately before exercise in the heat to 1 hour after exercise in the heat.
Concentrations of both IGBFP7 and TIMP-2 will be measured in the urine. The mathematical product of these values (IGFBP7 x TIMP-2) will then be calculated and reported for each time point.
次要结局
未报告次要终点
研究者
Jon Specht
Assistant Professor
University of Northern Iowa