Gatorade Sports Science Institute
Valhalla, New York, 10595, United States
Location status: Recruiting
NCT Number: NCT07298863
Metabolic flexibility is the ability to properly switch between fat and carbohydrate stores to use for energy under different conditions (rest, feeding, exercise). Impairments in metabolic flexibility, also known as metabolic inflexibility, have been suggested to be an underlying cause of metabolic disease, like type 2 diabetes. Long-term low fluid intake may increase the risk of type 2 diabetes due to insulin resistance, a form of metabolic inflexibility. Further, low fluid intake has been shown to impair the ability to switch fuel preference during exercise.
While there is some evidence that low fluid intake may lead to impaired metabolic flexibility, more information is needed. Therefore, the purpose of this study is to evaluate the impact of hydration status on substrate preference at rest and during exercise at varying intensities (light and moderate). Further, we will examine whether biological sex and menstrual cycle phase impact hydration and metabolism under these same conditions.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Valhalla, New York, 10595, United States
Location status: Recruiting
The 3-arm intervention will be completed in females during both the follicular and luteal phases for a total of 13 visits including the medical screening. In males, the 3-arm intervention will be completed once for a total of 7 visits including the medical screening.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device) while exercising on cycle ergometer.
Time frame: Exercise Trial- following bladder void at baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest Experimental Trial-following bladder void at baseline, post 10 min rest, post 1st and 2nd 30 min exercise sessions, and post 20 min rest
kg
Time frame: 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.
pmol/L
Time frame: 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.
mOsm/kg
Time frame: 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.
mg/dL
Time frame: 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.
mmol/L
Time frame: 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.
cells/uL
Time frame: 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
au
Time frame: 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
mOsm/kg
Time frame: 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
g
Time frame: 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
Scale of 1 (most hydrated) to 7 (most dehydrated)
Time frame: 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.
resting metabolism measured by Cosmed Quark or similar device. Exercise metabolism measured by Moxus or similar device.
Time frame: 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.
kcal-resting metabolism measured by Cosmed Quark or similar device. Exercise metabolism measured by Moxus or similar device.
Time frame: Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
mL/kg/min measured using indirect calorimetry (Moxus or similar device)
Time frame: At medical screening to determine body composition
kg measured using BodPod
Time frame: documented by subject on provided log for 24 hours prior to exercise and experimental trials. Exercise and Experimental Trial- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
mL
Time frame: Medical Screening to determine eligibility
systolic/diastolic (mmHg)
Time frame: 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.
bpm
Time frame: 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.
W
Time frame: Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
[Body mass loss (kg) + fluid intake (mL)]/Duration of exercise (hr)
Time frame: Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
Time frame: 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.
Borg scale of rating of perceived exertion. Rated on a 6-20 scale from No exertion at all to maximal exertion.
Time frame: After medical screening and one month prior to first study session
Current status (e.g., contraception, regular periods or not, etc.) tracked by physical log or an at-home menstrual cycle monitoring kit (Proov)
Time frame: Through study completion, an average of 3 weeks for male subjects and 8 weeks for female subjects.
Documented changes in health and symptoms
Contact information is provided by the study sponsor or research team.
PepsiCo Global R&D
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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