Effekten av hydreringsstatus på substratoksidasjon i hvile og under lett og moderat trening
25. august 2026 oppdatert av: PepsiCo Global R&D
Metabolisk fleksibilitet er evnen til å skifte korrekt mellom fett- og karbohydratlagre for å bruke som energi under forskjellige forhold (hvile, måltid, trening). Nedsatt metabolsk fleksibilitet, også kjent som metabolsk ufleksibilitet, har blitt foreslått å være en underliggende årsak til metabolsk sykdom, som type 2-diabetes. Langvarig lav væskeinntak kan øke risikoen for type 2-diabetes på grunn av insulinresistens, en form for metabolsk ufleksibilitet. Videre har lav væskeinntak vist seg å svekke evnen til å skifte drivstoffpreferanse under trening.
Selv om det er noe bevis for at lav væskeinntak kan føre til nedsatt metabolsk fleksibilitet, trengs mer informasjon. Derfor er formålet med denne studien å evaluere innvirkningen av hydreringsstatus på substratpreferanse i hvile og under trening med varierende intensiteter (lett og moderat). Videre vil vi undersøke om biologisk kjønn og menstruasjonssyklusfase påvirker hydrering og metabolisme under de samme forholdene.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert beskrivelse
Den 3-armede intervensjonen vil bli gjennomført hos kvinner i både follikelfasen og lutealfasen, totalt 13 besøk inkludert den medisinske screeningen.
Hos menn vil den 3-armede intervensjonen bli gjennomført én gang, totalt 7 besøk inkludert den medisinske screeningen.
Studietype
Intervensjonell
Registrering (Antatt)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Newcastle, Ontario, Canada, L1B0A9
- PeakGenics Innovation InPeakGenics Innovation Incc
-
-
-
-
New York
-
Valhalla, New York, Forente stater, 10595
- Gatorade Sports Science Institute
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- Deltakeren er mann eller kvinne
- Hvis kvinne, er deltakeren ikke gravid (basert på egenrapportering)
- Hvis kvinne, har deltakeren sluttet med prevensjonsmedisin eller fjernet langtidsvirkende reversibel prevensjon >6 måneder før studiestart
- Hvis kvinne, har deltakeren normal menstruasjonssyklus (21-35 dager)
- Hvis kvinne, er deltakeren villig til å følge sin menstruasjonssyklus
- Hvis kvinne, har deltakeren en smarttelefon kompatibel med app for å følge menstruasjonssyklus (kun kvinner) og/eller bærbare data (kvinner og menn)
- Deltakeren er 18-35 år, inklusive
- Deltakerens kroppsmasseindeks (BMI) er mellom 18,5-25 kg/m²
- Deltakeren er minst rekreasjonelt aktiv (driver med moderat intensitet, intermitterende eller kontinuerlig trening minst 3 dager per uke i minst 60 minutter om gangen)
- Deltakeren er vant til å sykle i minst 60 minutter
- Deltakeren røyker ikke (eller har sluttet i minst 6 måneder)
- Deltakeren tar ikke medisiner som kan forstyrre studien (f.eks. vanndrivende midler, avføringsmidler eller vekttapsmedisiner)
- Deltakeren har ingen helseproblemer som vil forstyrre studien som angitt på det generelle helseskjemaet (GHQ), f.eks. hjerte-kar-, nyre- eller metabolske sykdommer
- Deltakeren er ikke aktivt involvert i vekttapsintervensjon (diett og/eller anti-fedme medisiner)
- Deltakeren er ikke allergisk mot lim (f.eks. medisinsk tape)
- Deltakeren er villig til å unngå alkohol inntak 24 timer før besøk(ene)
- Deltakeren er villig til å faste over natten (~8-12 timer)
- Deltakeren er villig til å avstå fra intens trening i 24 timer (kun lett fysisk aktivitet)
- Deltakeren er villig til å bli barbert på plaster- eller elektrodested, om nødvendig
- Deltakeren er villig til å spise nøyaktig samme mat dagen før hvert besøk til laboratoriet
- Kan snakke, skrive og lese engelsk
- Gir skriftlig samtykke til å delta
Eksklusjonskriterier:
- Deltakeren har deltatt i en klinisk studie innen de siste 30 dagene
- Deltakeren har deltatt i noen PepsiCo-studie innen de siste 36 månedene
- Deltakeren har en tilstand eller tar medisiner som forskeren mener vil forstyrre hans/hennes evne til å gi informert samtykke, følge studiens protokoll, som kan forvirre tolkningen av studieresultatene, eller sette personen i unødig risiko
- Deltakeren er allergisk mot alkohol (alkoholforberedelsesputer brukes ved blodprøvetaking)
- Hvis kvinne, tar deltakeren prevensjonsmedisin eller har langtidsvirkende reversibel prevensjon
- Hvis mann, gjennomgår deltakeren hormonbehandling for å endre testosteronnivåer (injeksjoner, transdermal plaster, pille, etc.)
- Deltakeren er ansatt av, eller har en forelder, verge eller annet nært familiemedlem ansatt i et selskap som produserer produkter som konkurrerer med noe Gatorade-produkt. Hvis deltakeren er usikker på om et selskap vil bli ansett som en konkurrent til Gatorade, vil de bli bedt om å gi studieansvarlig navnet på det andre selskapet og arten av deres forhold til det selskapet før de signerer det informerte samtykket.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Part 1- Dehydrated control trial
Fluid restriction during exercise and for remaining 24 hours
|
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).
|
|
Annen: Part 1 - Euhydrated with water
Euhydrated with water to account for sweat loss and to maintain hydration over 24-hour period
|
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).
|
|
Eksperimentell: 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
|
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).
|
|
Eksperimentell: Part 2 - Euhydrated with water and electrolyte beverage
Euhydrated with water and electrolyte beverage to maintain euhydration status over 3-day study period
|
a 2-hour oral glucose tolerance test
|
|
Annen: Part 2 - Dehydration
fluid restriction during experimental period (3 days),
|
a 2-hour oral glucose tolerance test
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Part 1 only.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device) while exercising on cycle ergometer.
|
Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
|
|
Blood glucose levels
Tidsramme: baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
|
Part 2 only. mg/dL
|
baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Menstruasjonskategorisering
Tidsramme: Etter medisinsk screening og en måned før første studieøkt
|
Nåværende status (f.eks. prevensjon, regelmessige menstruasjoner eller ikke, etc.) spores via fysisk logg eller et hjemme-monitoringssett for menstruasjonssyklus (Proov)
|
Etter medisinsk screening og en måned før første studieøkt
|
|
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
|
Part 1 & 2. kg
|
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
|
|
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.
|
Part 1 & 2. pmol/L
|
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.
|
|
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.
|
Part 1 & 2. mOsm/kg
|
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.
|
|
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.
|
Part 1. mg/dL
|
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.
|
|
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.
|
Part 1 & 2. mmol/L
|
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.
|
|
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.
|
Part 1 & 2. cells/uL
|
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.
|
|
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.
|
Part 1 & 2. au
|
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.
|
|
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
|
Part 1 & 2. mOsm/kg
|
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
|
|
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
|
Part 1 & 2. g
|
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
|
|
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.
|
Part 1 & 2. Scale of 1 (most hydrated) to 7 (most dehydrated)
|
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.
|
|
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.
|
Part 1 & 2. resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
|
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.
|
|
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.
|
Part 1 & 2. kcal-resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
|
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.
|
|
VO2 peak
Tidsramme: Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
|
Part 1 only.
mL/kg/min measured using indirect calorimetry (Moxus or similar device)
|
Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
|
|
Fat and fat-free mass
Tidsramme: At medical screening to determine body composition
|
Part 1 & Part 2. kg measured using BodPod
|
At medical screening to determine body composition
|
|
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).
|
Part 1 & Part 2. mL
|
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).
|
|
Blood Pressure
Tidsramme: Medical Screening to determine eligibility
|
Part 1 only.
systolic/diastolic (mmHg)
|
Medical Screening to determine eligibility
|
|
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.
|
Part 1 only. bpm
|
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.
|
|
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.
|
Part 1 Only. W
|
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.
|
|
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.
|
Part 1 only.
[Body mass loss (kg) + fluid intake (mL)]/Duration of exercise (hr)
|
Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
|
|
Wearable Sensr Data
Tidsramme: Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
|
Part 1 only.
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
|
Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
|
|
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.
|
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.
|
|
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.
|
Part 1 & 2. Documented changes in health and symptoms
|
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.
|
|
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).
|
30 min pre-2 hour OGTT.
|
|
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.
|
documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT to confirm similar diets across trial days.
|
|
AUC during OGTT
Tidsramme: Across 2 hour OGTT at 30 min increments.
|
Part 2 only.
Area under the curve
|
Across 2 hour OGTT at 30 min increments.
|
|
Plasma insulin concentration
Tidsramme: Across 2 hour OGTT at 30 min increments.
|
Part 2 only. insulin units
|
Across 2 hour OGTT at 30 min increments.
|
|
Continuous Glucose Monitor (CGM) Outputs
Tidsramme: Throughout study participation, an average of 1 week for males and 4 weeks for females.
|
Part 2 only.
time in range, time above range, time below range
|
Throughout study participation, an average of 1 week for males and 4 weeks for females.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. november 2025
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
24. november 2025
Først innsendt som oppfylte QC-kriteriene
8. desember 2025
Først lagt ut (Faktiske)
23. desember 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PEP-2507
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .