The Effect of AMP Human Sodium Bicarbonate Lotion on Physiological and Cognitive Performance During Dehydrated Heat Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Hydration Status - Change in 24-h Urine USG
研究概览
简要总结
The primary purpose of the proposed study is to evaluate the effects of a topical sodium bicarbonate lotion (PR Lotion, AMP Human, Park City, UT) on measures of hydration status and fluid balance in humans when exposed to the heat while resting and during light/moderate aerobic exercise. A secondary purpose is to examine these same effects with two differing dosage patterns of the lotion. A tertiary purpose is to investigate the effect of an amino acid rehydration beverage in comparison to a placebo on measurements of hydration, subjective assessments of stress, and vestibular as well as musculoskeletal measures of fatigue for up to 24-hours after the completion of both passive and exertional heat stress within a dehydrated state.
详细描述
Design This laboratory study will involve the inclusion of 20 male participants from the local community and university who are within the age range of 18 - 45 years old and can be classified as recreationally active adults as indicated by a VO2max minimum (45 ml/kg/min) who choose to volunteer for this research study. This project will be conducted within the thermal physiology laboratory, complete with a climatic chamber (Cantrol, CES +13/+44) located within the Human Performance Laboratory (HPL) at the University of Connecticut. We expect data collection to take approximately 3-4 months for completion and each interested individual will complete all five trials included within the study design within a randomized, counterbalanced order.
Participants will be randomly assigned de-identified codes, trial grouping orders, and allocation of amino acid rehydration beverages (i.e., aminoVITAL Rapid Recovery or Placebo) after approval has been provided and consent has been obtained. The order of participation will be counterbalanced between participants to ensure that there is not an order effect with each participant completing all 5 trials outlined in the study design. Additionally, for the post trial amino acid rehydration portion of the study only, participants will be matched based on an assortment of physiological variables measured (i.e., physical fitness [VO2max], body mass index, body surface area, age, height, and/or weight) in regards to their assigned allocation of the amino acid rehydration beverages (i.e., aminoVITAL Rapid Recovery or Placebo) that will be consumed during the recovery period of the study design.
Environmental Conditions Session I as well as all Baseline Visits and matched-control 24-hour Rehydration Sessions (i.e., AminoVITAL Rapid Recovery or Placebo) will be completed within thermoneutral conditions. Moreover, all Dehydration Periods associated with completion of the study will be completed by the participant outside of the laboratory. Finally, all counterbalanced testing sessions (i.e., 0.8PR-Fluid, 0.4PR-Fluid, PLA-Fluid, 0.8PR-Dry, and PLA-Dry) will be conducted within the climatic chamber set to a climate with an ambient temperature at approximately 330C (91.40F) and relative humidity at approximately 25%.
Baseline and VO2max Testing - Session 1 Session 1 will serve as a baseline testing session to obtain an assortment of physiological, vestibular, strength, and cognitive measurements to conduct an effective baseline measurement for each individual participating in this study. Physiological assessments will include measurements of each individual's body composition (height, weight, and body fat percentage), cardiovascular health (resting blood pressure, heart rate, and HRV), and aerobic fitness level via assessment of maximal oxygen consumption (VO2max). Furthermore, participants will be assessed for their cognitive abilities (ANAM testing battery), vestibular performance (BESS) and physical performance (grip strength and grip endurance). For the completion of this testing session, participants will be instructed to consume an efficient amount of fluids to ensure proper hydration for testing. Additionally, participants will be instructed to refrain from eating or smoking for up to 3 hours before the beginning of their session.
Arrival Procedures:
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Males within the age range of 18- 45 years old.
- •Individuals who are classified as recreationally active adults as indicated by a VO2max minimum (45 ml/kg/min)
- •Individuals who measure with a BMI of ≤ 28
- •Individuals who have been medically cleared for participation in this study by the medical safety monitor.
排除标准
- •Cannot understand English (written and/or verbally communicated).
- •Hearing impaired to where verbal communications cannot be understood and/or followed safely.
- •Individuals who report a history of COVID-19 unless cleared by a physician for exercise at the performance level required to participate in this study. The physician must be made aware of what is required to participate in this study.
- •Individuals who self-report history of complications with psychological disorders or chronic illness (eating disorders, cardiovascular, kidney, liver, metabolic, neuromuscular, pulmonary, integumentary, and/or sickle cell disease).
- •Individuals who have chronic health problems that may affect the participant's ability to thermoregulate or sweat normally.
- •Individuals who have a history of exertional heat illness within the past 3 years.
- •Individuals who are taking any prescription or non-prescription medication(s) that may specifically impact cardiometabolic, pulmonary, renal, integumentary, and/or thermoregulatory function (i.e. amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin, and water pills).
- •Individuals who are taking any prescription medication for diabetes mellitus, Parkinson's disease, or kidney disease.
- •Individuals who have donated blood within the previous month.
- •Individuals who have an implanted pacemaker or internal defibrillator.
- •Individuals who report a history of claustrophobia
- •Individuals classified as hypertensive while at rest (SBP: ≥140 mmHg and/or DBP: ≥90 mmHg; will be measured during first visit).
- •Individuals who have not abstained from use of supplements that may affect/enhance hydration status and/or rehydration protocol measurements (i.e. creatine, sodium bicarbonate, potassium, magnesium, dandelion, vitamin B, protein powder, BCAAs, fish oil, multivitamins, soluble fiber, other natural diuretics) at time of testing.
- •Individuals who are suffering from a current musculoskeletal injury or active lesion of the skin that inhibits the participant's ability to complete all tasks required for participation.
- •Individuals who are allergic/sensitive to adhesive materials (i.e., medical tape)
- •Individuals who are allergic/sensitive to ingredients within the study-specific Topical Lotions: (Menthol [0.5%], sodium bicarbonate (baking soda), water, isopropyl palmitate, lecithin, poloxamer 407, cetyl alcohol, propylene glycol, denatured alcohol, benzyl alcohol, polyglyceryl-4 laurate, sodium hydroxide, sodium lauryl sulfate, sorbic acid, and fragrance) as well as iodine and/or medical tape.
- •Individuals who are allergic/sensitive to ingredients within the study specific amino acid beverages: highly branched cyclic dextrin, citric acid, malic acid, natural fruit flavor, rebaudioside (stevia leaf extract), and vegetable juice for color.
结局指标
主要结局
Hydration Status - Change in 24-h Urine USG
时间窗: Intervention Trial at the -45 minute mark
Assessment of hydration status via collection of urine USG
Hydration Status - Change in Acute Urine USG
时间窗: Intervention Trial at the 80 minute mark
Assessment of hydration status via collection of urine USG
Renal Electrolyte Levels - Change in 24-h Urine Potassium
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine potassium excretion
Renal Electrolyte Levels - Change in Urine Potassium
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal electrolyte levels via collection of urine potassium excretion
Systemic Osmotic Stress - Change in Plasma Osmolality
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels
Renal Function - Change in Acute Urinary TIMP2 Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels
Renal Function - Change in Plasma Creatinine Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels
Renal Electrolyte Levels - Change in Acute Urine Sodium
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine sodium excretion
Systemic Electrolyte Levels - Change in Plasma Chloride
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of circulatory electrolyte levels via collection of plasma chloride levels
Renal Function - Change in Urinary BUN Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels
Renal Function - Change in Urinary TIMP2 Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels
Hydration Status - Change in Urine USG
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of hydration status via collection of urine USG
Hydration Status - Change in 24-h Urine Osmolality
时间窗: Intervention Trial at the -45 minute mark
Assessment of hydration status via collection of urine osmolality
Hydration Status - Change in Urine Osmolality
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of hydration status via collection of urine osmolality
Renal Electrolyte Levels - Change in Urine Sodium
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal electrolyte levels via collection of urine sodium excretion
Renal Electrolyte Levels - Change in Acute Urine Potassium
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine potassium excretion
Renal Electrolyte Levels - Change in Acute Urine Chloride
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine chloride excretion
Renal Electrolyte Levels - Change in Urine Chloride
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal electrolyte levels via collection of urine chloride excretion
Systemic Electrolyte Levels - Change in Plasma Sodium
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of circulatory electrolyte levels via collection of plasma sodium levels
Systemic Electrolyte Levels - Change in Plasma Potassium
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of circulatory electrolyte levels via collection of plasma potassium levels
Renal Function - Change in Acute Urinary Creatinine Levels
时间窗: Intervention Trial at the 220 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels
Renal Function - Change in 24-h Urinary Creatinine Levels
时间窗: Phase-specific PRE Session
Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels
Renal Function - Change in Chronic Urinary BUN Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels
Hydration Status - Change in Acute Urine Osmolality
时间窗: Intervention Trial at the -45 minute mark
Assessment of hydration status via collection of urine osmolality
Renal Electrolyte Levels - Change in 24-h Urine Sodium
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine sodium excretion
Renal Electrolyte Levels - Change in 24-h Urine Chloride
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal electrolyte levels via collection of urine chloride excretion
Renal Function - Change in Urinary Creatinine Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels
Renal Function - Change in 24-h Urinary BUN Levels
时间窗: Phase-specific PRE Session
Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels
Renal Function - Change in Urinary IGFBP7 Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels
Renal Function - Change in 24-h Urinary TIMP2 Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels
Renal Function - Change in Plasma TIMP2 Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels
Renal Function - Change in Acute Urinary BUN Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels
Renal Function - Change in Acute Urinary IGFBP7 Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels
Renal Function - Change in 24-h Urinary IGFBP7 Levels
时间窗: Intervention Trial at the -45 minute mark
Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels
Renal Function - Change in Plasma BUN Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels
Renal Function - Change in Plasma IGFBP7 Levels
时间窗: Rehydration Protocol - 24 hours post-intervention
Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels
次要结局
- Protein Content - Change in Plasma Protein Levels(Rehydration Protocol - 24 hours post-intervention)
- Cardiovascular Function - Change in Heart Rate Variability(Rehydration Protocol - 24 hours post-intervention)
- Cognitive Differences - Changes in 2 Choice Reaction Time(Rehydration Protocol - 24 hours post-intervention)
- Hydration Status - Change in 24-h Urine Color(Intervention Trial at the -45 minute mark)
- Performance Differences - Changes in Balance(Rehydration Protocol - 24 hours post-intervention)
- Performance Differences - Changes in Muscular Endurance Testing(Intervention Trial at the 220 minute mark)
- Performance Differences - Changes in Oxygen Consumption(Intervention Trial at the 215 minute mark)
- Hydration Status - Change in Urine Color(Rehydration Protocol - 24 hours post-intervention)
- Cardiovascular Function - Change in Blood Pressure(Rehydration Protocol - 24 hours post-intervention)
- Cognitive Differences - Changes in Stroop Test(Rehydration Protocol - 24 hours post-intervention)
- Hydration Status - Change in Whole Blood Plasma Volume Shifts(Rehydration Protocol - 24 hours post-intervention)
- Hydration Status - Change in Acute Urine Color(Intervention Trial at the -45 minute mark)
- Performance Differences - Changes in Muscular Strength Testing(Rehydration Protocol - 24 hours post-intervention)
- Cognitive Differences - Changes in Matching to Samples Test(Rehydration Protocol - 24 hours post-intervention)
研究者
Douglas J Casa
Principal Investigator
University of Connecticut