Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Standard measurements of hydration status: Thirst
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 hydration status, including: 1) at various timepoints throughout a 24-hour period in healthy adults from the general population (GENPOP), and 2) before and after a team coach-led training session in athletes competing in a sport (ATHLETE). TOI data will be collected alongside standard reference measures of hydration status.
In this study each subject will serve as their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both Study Arms (GENPOP and ATHLETE)
- •Subject is male or female
- •If female, subject is not pregnant
- •Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- •Subject is willing to avoid wearing makeup to the study session or willing to remove it with facial wipes before the face scans
- •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
- •GENPOP Study
- •Study subject is 18-65 years of age, inclusive
- •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 fast overnight (~8-12 hours)
- •Subject is willing to refrain from vigorous exercise for 48 hours
- •Subject is willing to eat the exact same food the day prior to each visit to the testing site
- •ATHLETE Study
- •Study subject is 14-45 years of age, inclusive
- •Subject is participating in team sport training/competition
- •Subject is participating in a coach-led practice
排除标准
- •Both Study Arms (GENPOP and ATHLETE)
- •Subject has participated or currently enrolled 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 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.
- •GENPOP Study
- •Subject has a health condition or is taking medication that can be worsened by fluid restriction (participants who opt-in to fluid restriction study arm only)
研究组 & 干预措施
ATHLETE ad libitum fluid intake
For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Permitted to drink during training session.
干预措施: ATHLETE ad libitum fluid intake (Other)
ATHLETE with fluid restriction
For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Not permitted to drink during training session.
干预措施: ATHLETE restricted fluid intake (Other)
GENPOP passive dehydration
In the 24 hours between the first and last face scan, reduce fluid intake by approximately 75% (equating to approximately 700 ml (women) and 800 ml (men)). Participants will be provided pre-filled water bottles and asked to only ingest fluid in bottle until second morning face scan.
干预措施: GENPOP fluid restriction (Other)
GENPOP ad libitum fluid intake
No fluid restriction
干预措施: GENPOP ad libitum fluid intake (Other)
结局指标
主要结局
Standard measurements of hydration status: Thirst
时间窗: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
Transdermal Optical Imaging (TOI) signals
时间窗: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Blood flow patterns of the face obtained from the video camera on a smart phone
Standard measurement of hydration status: Body mass change
时间窗: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
Standard measurements of hydration status: Urine specific gravity
时间窗: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Digital pen refractometer (Atago, PEN-Urine SG)
Standard measurements of hydration status: Urine color
时间窗: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
次要结局
- Subject demographics - Age(At screening)
- Dietary and fluid intake(For GENPOP from 24 hours prior to Day 1 visit (~8 a.m.) through end of testing period (Day 2 ~8 a.m.). For ATHLETES from 24 hours to prior to start of single ~45 minute exercise session (if fluid restricted) or to end of exercise (if ad lib fluid intake))
- Subject demographics - Ethnicity(At screening)
- Subject demographics - Sex(At screening)
- Fitzpatrick classification of skin color(At screening)
- Mood scale(Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise)
- Subject demographics - Race(At screening)