Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Transdermal optical imaging (TOI) signals
研究概览
简要总结
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status.
This is an exploratory pilot proof of concept study with each subject serving as their own control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female
- •If female, subject is not pregnant
- •For GENPOP study subject is 18-65 years of age, inclusive
- •For EXERCISE study subject is 18-50 years of age, inclusive
- •Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 1 hour at a time (EXERCISE session participants only)
- •Subject does not smoke (or has quit for at least 6 months)
- •Subject is not taking medication that may interfere with the study
- •Subject has no health conditions that would prevent completion of the trial as indicated on the general health questionnaire (GHQ)
- •Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- •Subject is willing to fast overnight (~8-12 hours)
- •For GENPOP, subject is willing to refrain from vigorous exercise for 48 hours
- •For EXERCISE, subject is willing to refrain from vigorous exercise for 24 hours prior to study visits
- •Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- •Subject is willing to avoid wearing makeup to the study session
- •Subject is willing to shave facial hair if predetermined during the informed consent session it will interfere with TOI measurement
- •Able to speak, write, and read English
- •Provision of written consent to participate
排除标准
- •Subject has participated in a clinical trial within the past 30 days
- •Subject has participated in any PepsiCo trial within past 6 months
- •Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- •Subject is allergic to alcohol or facial cleansing wipes
- •Subject has a history of anaphylaxis or severe allergic reactions
- •Subjects has a health condition or is taking medication that can be worsened by fluid restriction
- •Subject has asthma or other condition which breathing can become labored during exercise (EXERCISE session participants only)
- •Male subjects with a VO2max < 42 ml/kg/min and females with a VO2max < 38 ml/kg/min (EXERCISE session participants only)
- •Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
研究组 & 干预措施
GENPOP passive dehydration
24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
干预措施: GENPOP Passive dehydration (75% reduction in fluid intake (Other)
EXERCISE without fluid replacement
Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.
干预措施: EXERCISE without fluid replacement (Other)
GENPOP ad lib fluid intake
24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
干预措施: GENPOP Ad lib fluid intake (Other)
EXERCISE with fluid replacement
Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.
干预措施: EXERCISE with fluid replacement (Other)
结局指标
主要结局
Transdermal optical imaging (TOI) signals
时间窗: GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise session allowing for 30 minute cool down period.
Blood flow patterns of the face obtained from the video camera on a smart phone
Standard measurements of hydration status
时间窗: GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise sessions allowing for 30 minute cool down period.
Body mass change, urine specific gravity, urine color (1-8 scale), and visual analogue scale to indicate thirst (1=not thirsty at all to 7 very, very thirsty)
次要结局
- EXERCISE only: Fingertip capillary blood biomarkers(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- Demographics(At screening)
- Fitzpatrick scale(At screening)
- Dietary and fluid intake(24 hours prior to each visit through end of each study period.)
- EXERCISE only: Rate of perceived exertion (RPE)(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- Mood scale(GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day)
- EXERCISE only: Heart rate(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Fluid intake (euhydrated state)(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Grittiness score(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Visual analogue scale for mental energy and fatigue(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Work rate(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Sweating rate(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Physical and mental energy(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Sweat biomarkers(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)
- EXERCISE only: Saliva biomarkers(Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days)