Effekten af hydreringsstatus på substratoxidation i hvile samt under let og moderat motion
25. august 2026 opdateret af: PepsiCo Global R&D
Effekten af hydreringsstatus på substratoxidation i hvile og under let og moderat motion
Metabolisk fleksibilitet er evnen til korrekt at skifte mellem fedt- og kulhydratlagre for at bruge til energi under forskellige forhold (hvile, indtagelse, træning). Nedsættelser i metabolisk fleksibilitet, også kendt som metabolisk ufleksibilitet, er blevet foreslået at være en underliggende årsag til metabolisk sygdom, som type 2-diabetes. Langvarigt lavt væskindtag kan øge risikoen for type 2-diabetes på grund af insulinresistens, en form for metabolisk ufleksibilitet. Desuden har det vist sig, at lavt væskindtag nedsætter evnen til at skifte brændstofpræference under træning.
Selvom der er noget evidens for, at lavt væskindtag kan føre til nedsat metabolisk fleksibilitet, er der behov for mere information. Derfor er formålet med denne undersøgelse at evaluere indvirkningen af hydreringsstatus på substratpræference i hvile og under træning ved varierende intensiteter (let og moderat). Desuden vil vi undersøge, om biologisk køn og menstruationscyklusfase påvirker hydrering og stofskifte under disse samme forhold.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Den 3-armede intervention vil blive gennemført hos kvinder i både follikelfasen og lutealfasen i alt 13 besøg inklusive den medicinske screening.
Hos mænd vil den 3-armede intervention blive gennemført én gang i alt 7 besøg inklusive den medicinske screening.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
104
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Newcastle, Ontario, Canada, L1B0A9
- PeakGenics Innovation InPeakGenics Innovation Incc
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New York
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Valhalla, New York, Forenede Stater, 10595
- Gatorade Sports Science Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Deltageren er mand eller kvinde
- Hvis kvinde, er deltageren ikke gravid (baseret på selvrapportering)
- Hvis kvinde, har deltageren stoppet med at tage præventionsmedicin eller fjernet langtidsvirkende reversibel prævention >6 måneder før studiestart
- Hvis kvinde, har deltageren normal menstruationscyklus (21-35 dage)
- Hvis kvinde, er deltageren villig til at registrere sin menstruationscyklus
- Hvis kvinde, har deltageren en smartphone kompatibel med applikation til registrering af menstruationscyklus (kun kvinder) og/eller wearables-data (kvinder og mænd)
- Deltageren er 18-35 år, inklusive
- Deltagerens kropsmasseindeks (BMI) er mellem 18,5-25 kg/m²
- Deltageren er mindst fritidsaktiv (deltager i moderat intensitet, intermitterende eller kontinuerlig træning mindst 3 dage om ugen i mindst 60 min ad gangen)
- Deltageren er vant til at cykle i mindst 60 min
- Deltageren ryger ikke (eller har holdt op i mindst 6 måneder)
- Deltageren tager ikke medicin, der kan forstyrre studiet (f.eks. vanddrivende midler, afføringsmidler eller vægttabsmedicin)
- Deltageren har ingen helbredstilstande, der vil forstyrre studiet som angivet på det generelle helbredsspørgeskema (GHQ), f.eks. hjerte-kar-, nyre- eller stofskiftesygdomme
- Deltageren er ikke aktivt involveret i vægttabsintervention (diæt og/eller anti-fedme-medicin)
- Deltageren er ikke allergisk over for klæbemidler (f.eks. medicinsk tape)
- Deltageren er villig til at undgå alkoholindtagelse 24 timer før besøg(ene)
- Deltageren er villig til at faste om natten (~8-12 timer)
- Deltageren er villig til at undlade intens træning i 24 timer (kun let fysisk aktivitet)
- Deltageren er villig til at blive barberet ved plaster- eller elektrodested, hvis nødvendigt
- Deltageren er villig til at spise nøjagtig den samme mad dagen før hvert besøg i laboratoriet
- Kan tale, skrive og læse engelsk
- Aflægge skriftligt samtykke til deltagelse
Eksklusionskriterier:
- Deltageren har deltaget i et klinisk forsøg inden for de sidste 30 dage
- Deltageren har deltaget i et hvilket som helst PepsiCo-forsøg inden for de sidste 36 måneder
- Deltageren har en tilstand eller tager medicin, som undersøgeren mener vil forstyrre hans/hendes evne til at give informeret samtykke, overholde studioprotokollen, hvilket kan forvirre fortolkningen af studieresultaterne, eller udsætte personen for urimelig risiko
- Deltageren er allergisk over for alkohol (alkoholprepads bruges til blodprøver)
- Hvis kvinde, tager deltageren præventionsmedicin eller har langtidsvirkende reversibel prævention
- Hvis mand, gennemgår deltageren hormonbehandling for at ændre testosteronniveauer (injektioner, transdermal plaster, pille, etc.)
- Deltageren er ansat hos, eller har en forælder, værge eller anden nærtstående familieansat ansat i et firma, der fremstiller produkter, der konkurrerer med et hvilket som helst Gatorade-produkt. Hvis deltageren er usikker på, om et firma ville blive betragtet som en konkurrent til Gatorade, vil de blive bedt om at fortælle undersøgeren navnet på det andet firma og arten af deres forhold til det firma, før de underskriver det informerede samtykke.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Part 1- Dehydrated control trial
Fluid restriction during exercise and for remaining 24 hours
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Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
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Andet: Part 1 - Euhydrated with water
Euhydrated with water to account for sweat loss and to maintain hydration over 24-hour period
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Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
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Eksperimentel: Part 1 - Euhydrated with electrolyte beverage
Euhydrated with electrolyte beverage (220 mg sodium in 20 oz) to account for sweat loss and to maintain hydration over 24-hour period
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Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
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Eksperimentel: Part 2 - Euhydrated with water and electrolyte beverage
Euhydrated with water and electrolyte beverage to maintain euhydration status over 3-day study period
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a 2-hour oral glucose tolerance test
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Andet: Part 2 - Dehydration
fluid restriction during experimental period (3 days),
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a 2-hour oral glucose tolerance test
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Respiratory Exchange Ratio
Tidsramme: Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
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Part 1 only.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device) while exercising on cycle ergometer.
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Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
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Blood glucose levels
Tidsramme: baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
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Part 2 only. mg/dL
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baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Menstruationskategorisering
Tidsramme: Efter medicinsk screening og en måned før første studiesession
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Nuværende status (f.eks. prævention, regelmæssige menstruationer eller ej, osv.) registreret via fysisk log eller et hjemmemonitoringssæt til menstruationscyklus (Proov)
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Efter medicinsk screening og en måned før første studiesession
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Body Mass
Tidsramme: Exercise - after bladder void at baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental -after bladder void at baseline, post 10 min rest, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post
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Part 1 & 2. kg
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Exercise - after bladder void at baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental -after bladder void at baseline, post 10 min rest, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post
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Plasma copeptin concentration
Tidsramme: Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Part 1 & 2. pmol/L
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Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Plasma osmolality
Tidsramme: Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Part 1 & 2. mOsm/kg
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Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Blood glucose
Tidsramme: At medical screening to determine eligibility. Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest.
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Part 1. mg/dL
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At medical screening to determine eligibility. Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest.
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Blood lactate
Tidsramme: Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Part 1 & 2. mmol/L
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Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Peripheral blood mononuclear cell (PBMC) mitochondrial function
Tidsramme: Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Part 1 & 2. cells/uL
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Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
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Urine Specific Gravity
Tidsramme: Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
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Part 1 & 2. au
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Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
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Urine Osmolality
Tidsramme: Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
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Part 1 & 2. mOsm/kg
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Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
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Urine mass
Tidsramme: Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
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Part 1 & 2. g
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Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
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Urine Color
Tidsramme: Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
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Part 1 & 2. Scale of 1 (most hydrated) to 7 (most dehydrated)
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Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
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Fat and Carbohydrate Oxidation
Tidsramme: Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
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Part 1 & 2. resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
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Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
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Energy Expenditure
Tidsramme: Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
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Part 1 & 2. kcal-resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
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Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
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VO2 peak
Tidsramme: Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
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Part 1 only.
mL/kg/min measured using indirect calorimetry (Moxus or similar device)
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Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
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Fat and fat-free mass
Tidsramme: At medical screening to determine body composition
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Part 1 & Part 2. kg measured using BodPod
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At medical screening to determine body composition
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Fluid Intake
Tidsramme: documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT. Exercise and Experimental Trial- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
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Part 1 & Part 2. mL
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documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT. Exercise and Experimental Trial- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
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Blood Pressure
Tidsramme: Medical Screening to determine eligibility
|
Part 1 only.
systolic/diastolic (mmHg)
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Medical Screening to determine eligibility
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Heart Rate
Tidsramme: At medical screening to determine eligibility. Throughout entire duration of each 90-120 min exercise trial. Throughout entire duration of 120-150 min of each experimental trial.
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Part 1 only. bpm
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At medical screening to determine eligibility. Throughout entire duration of each 90-120 min exercise trial. Throughout entire duration of 120-150 min of each experimental trial.
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Standardized Exercise Intensity
Tidsramme: Every 10 min throughout entire duration of each 60 min exercise trial to reach 70-80% of VO2 max. Every 10 min throughout entire duration of each 60 min experimental trial to reach 50-80% of VO2 max.
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Part 1 Only. W
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Every 10 min throughout entire duration of each 60 min exercise trial to reach 70-80% of VO2 max. Every 10 min throughout entire duration of each 60 min experimental trial to reach 50-80% of VO2 max.
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Sweat Rate
Tidsramme: Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
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Part 1 only.
[Body mass loss (kg) + fluid intake (mL)]/Duration of exercise (hr)
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Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
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Wearable Sensr Data
Tidsramme: Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
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Part 1 only.
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
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Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
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Rate of Perceived Exhaustion
Tidsramme: Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each exercise trial. Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each experimental trial.
|
Part 1 Only.
Borg scale of rating of perceived exertion.
Rated on a 6-20 scale from No exertion at all to maximal exertion.
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Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each exercise trial. Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each experimental trial.
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Adverse Events
Tidsramme: Through study completion. Part 1 only, an average of 3 weeks for males and 8 weeks for females. Part 2 only, an average of 1 week for males and 4 weeks for females. Part 1 & 2, an average of 4 weeks for males and 12 weeks for females.
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Part 1 & 2. Documented changes in health and symptoms
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Through study completion. Part 1 only, an average of 3 weeks for males and 8 weeks for females. Part 2 only, an average of 1 week for males and 4 weeks for females. Part 1 & 2, an average of 4 weeks for males and 12 weeks for females.
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RER
Tidsramme: 30 min pre-2 hour OGTT.
|
Part 2 only.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device).
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30 min pre-2 hour OGTT.
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Diet Log
Tidsramme: documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT to confirm similar diets across trial days.
|
Part 1 & 2.
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documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT to confirm similar diets across trial days.
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AUC during OGTT
Tidsramme: Across 2 hour OGTT at 30 min increments.
|
Part 2 only.
Area under the curve
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Across 2 hour OGTT at 30 min increments.
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Plasma insulin concentration
Tidsramme: Across 2 hour OGTT at 30 min increments.
|
Part 2 only. insulin units
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Across 2 hour OGTT at 30 min increments.
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Continuous Glucose Monitor (CGM) Outputs
Tidsramme: Throughout study participation, an average of 1 week for males and 4 weeks for females.
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Part 2 only.
time in range, time above range, time below range
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Throughout study participation, an average of 1 week for males and 4 weeks for females.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. november 2025
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
24. november 2025
Først indsendt, der opfyldte QC-kriterier
8. december 2025
Først opslået (Faktiske)
23. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PEP-2507
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .