임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06212518은(는) 탈수에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06212518은(는) 탈수에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2023년 10월 2일에 시작되어 1,000명의 참여자를 모집하고 있습니다. PepsiCo Global R&D이(가) 진행하며, 2024년 8월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 1월 19일에 갱신되었습니다.
간단한 개요
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.
공식 제목
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
질환/상태
탈수기타 연구 식별자
- PEP-2306 3b
NCT 번호
실제 연구 시작일
2023-10-02
최신 업데이트 게시
2024-01-19
예상 연구 완료일
2024-08-31
계획된 등록 인원
1,000
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
주요 목적
기초과학
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적GENPOP 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)). |
실험적GENPOP ad libitum fluid intake No fluid restriction | GENPOP Ad Libitum Fluid Intake Unrestricted fluid intake. |
실험적ATHLETE 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. |
실험적ATHLETE 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 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
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&D연구 대표 연락처
연락처: Matthew Hinkley, PhD, 914-742-4975, [email protected]
4 1개국에 임상시험 장소
Florida
Pepsico R&D Life Sciences, Bradenton, Florida, 34210, United States
Khalil Lee, PhD, 연락처, 334-728-0250, [email protected]
Matthew Hinkley, PhD, 연락처, 914-742-4975, [email protected]
모집중
Illinois
PepsiCo R&D Gatorade Sports Science Institute, Chicago, Illinois, 60607, United States
Shellen Goltz, PhD, 연락처, 312-821-3317, [email protected]
Matthew Hinkley, PhD, 연락처, 914-742-4975, [email protected]
모집중
New York
PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, 10595, United States
Matthew Hinkley, PhD, 연락처, 914-742-4975, [email protected]
Matthew Hinkley, PhD, 책임연구자
모집중
Texas
PepsiCo R&D, Gatorade Sports Science Institute, Plano, Texas, 75024, United States
Anthony Wolfe, MS, 연락처, 469-920-2862, [email protected]
Matthew Hinkley, PhD, 연락처, 914-742-4975, [email protected]
모집중