رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06212518 لـ الجفاف هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06212518 هي دراسة تدخُّلية لـالجفاف وهي قيد التجنيد. بدأت في ١٧ ربيع الأول ١٤٤٥ هـ مع خطة لتجنيد ١٬٠٠٠ مشاركًا. يقودها PepsiCo Global R&D، ومن المتوقع اكتمالها بحلول ٢٧ صفر ١٤٤٦ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٧ رجب ١٤٤٥ هـ.
الملخص
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.
العنوان الرسمي
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
الحالات الطبية
الجفافمعرّفات دراسة أخرى
- PEP-2306 3b
NCT معرّف
تاريخ البدء (فعلي)
2023-10-02
آخر تحديث مُنشور
2024-01-19
تاريخ الاكتمال (المقدر)
2024-08-31
عدد المشاركين المخطط لهم
١٬٠٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
hydration
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
dehydration
euhydration
hypohydration
exercise
Transdermal Optical Imaging
TOI
الغرض الأساسي
علوم أساسية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةGENPOP 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)). |
تجريبيةGENPOP ad libitum fluid intake No fluid restriction | GENPOP Ad Libitum Fluid Intake Unrestricted fluid intake. |
تجريبيةATHLETE 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. |
تجريبيةATHLETE 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 |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ, كبار السن
العمر الأدنى للدراسة
14 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
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&Dجهة اتصال مركزية للدراسة
جهة اتصال: Matthew Hinkley, PhD, 914-742-4975, [email protected]
4 مواقع الدراسة في 1 بلدان
Florida
Pepsico R&D Life Sciences, Bradenton, Florida, 34210, United States
Khalil Lee, PhD, جهة اتصال, 334-728-0250, [email protected]
Matthew Hinkley, PhD, جهة اتصال, 914-742-4975, [email protected]
قيد التجنيد
Illinois
PepsiCo R&D Gatorade Sports Science Institute, Chicago, Illinois, 60607, United States
Shellen Goltz, PhD, جهة اتصال, 312-821-3317, [email protected]
Matthew Hinkley, PhD, جهة اتصال, 914-742-4975, [email protected]
قيد التجنيد
New York
PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, 10595, United States
Matthew Hinkley, PhD, جهة اتصال, 914-742-4975, [email protected]
Matthew Hinkley, PhD, المحقق الرئيسي
قيد التجنيد
Texas
PepsiCo R&D, Gatorade Sports Science Institute, Plano, Texas, 75024, United States
Anthony Wolfe, MS, جهة اتصال, 469-920-2862, [email protected]
Matthew Hinkley, PhD, جهة اتصال, 914-742-4975, [email protected]
قيد التجنيد