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临床试验 NCT06212518 针对脱水目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
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临床试验NCT06212518是一项针对脱水的干预性研究试验，目前试验状态为招募中。试验始于2023年10月2日，计划招募1,000名患者。该研究由PepsiCo Global R&D主导，预计于2024年8月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年1月19日。
简要概括
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.
官方标题
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
疾病
脱水其他研究标识符
- PEP-2306 3b
NCT编号
实际开始日期
2023-10-02
最近更新发布
2024-01-19
预计完成日期
2024-08-31
计划入组人数
1,000
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
主要目的
基础研究
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | GENPOP Fluid Restriction 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)). |
实验性GENPOP ad libitum fluid intake No fluid restriction | GENPOP Ad Libitum Fluid Intake Unrestricted fluid intake. |
实验性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. | ATHLETE Restricted Fluid Intake Not permitted to drink during training session. |
实验性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. | ATHLETE Ad Libitum Fluid Intake No restriction on fluid intake |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Transdermal Optical Imaging (TOI) signals | Blood flow patterns of the face obtained from the video camera on a smart phone | 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 |
Standard measurement of hydration status: Body mass change | Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg) | 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 |
Standard measurements of hydration status: Urine specific gravity | Digital pen refractometer (Atago, PEN-Urine SG) | 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 |
Standard measurements of hydration status: Urine color | Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7 | 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 |
Standard measurements of hydration status: Thirst | Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty | 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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Subject demographics - Age | in years | At screening |
Subject demographics - Sex | male or female | At screening |
Subject demographics - Ethnicity | Hispanic or Latino, or not Hispanic or Latino | At screening |
Subject demographics - Race | American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White | At screening |
Fitzpatrick classification of skin color | Skin type from 1=White skin, always burns, never tans to 6 = Black skin, heavily pigmented, never burns, tans very easily | At screening |
Mood scale | Rated from 1=Calm to 9=Irritated | 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 |
Dietary and fluid intake | Food and fluid intake recorded on a paper log | 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) |
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
14 Years
适龄性别
全部
接受健康志愿者
是
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
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)
PepsiCo Global R&D研究中心联系人
联系人: Matthew Hinkley, PhD, 914-742-4975, [email protected]
4 位于 1 个国家/地区的研究中心
Florida
Pepsico R&D Life Sciences, Bradenton, Florida, 34210, United States
Khalil Lee, PhD, 联系人, 334-728-0250, [email protected]
Matthew Hinkley, PhD, 联系人, 914-742-4975, [email protected]
招募中
Illinois
PepsiCo R&D Gatorade Sports Science Institute, Chicago, Illinois, 60607, United States
Shellen Goltz, PhD, 联系人, 312-821-3317, [email protected]
Matthew Hinkley, PhD, 联系人, 914-742-4975, [email protected]
招募中
New York
PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, 10595, United States
Matthew Hinkley, PhD, 联系人, 914-742-4975, [email protected]
Matthew Hinkley, PhD, 主要研究者
招募中
Texas
PepsiCo R&D, Gatorade Sports Science Institute, Plano, Texas, 75024, United States
Anthony Wolfe, MS, 联系人, 469-920-2862, [email protected]
Matthew Hinkley, PhD, 联系人, 914-742-4975, [email protected]
招募中