The Effect of Hydration Status on Substrate Oxidation at Rest and During Light and Moderate Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorPepsiCo Global R&D
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is male or female
If female, subject is not pregnant (based on self-report)
If female, subject has stopped taking birth control medication or removed long-acting reversible contraceptive >6 months at start of the study
If female, subject has normal menstrual cycle (21-35 days)
Disqualifiers
Subject has participated in a clinical trial within the past 30 days
Subject has participated in any PepsiCo trial within past 36 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 (alcohol pre pads are used for blood draws
Trial design
Design model
Crossover
Treatments tested in this trial
Exercise Trial
Other interventionPerform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
Experimental Trial
Other intervention24h 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).
Treatment groups
74 Participants
are divided into 3 treatment groupsGroup A: Dehydrated control trialOther 2 interventions
Group B: Euhydrated with waterOther 2 interventions
Group C: Euhydrated with electrolyte beverageExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Respiratory Exchange Ratio
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device) while exercising on cycle ergometer.
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.Secondary outcomes
1
Body Mass
kg
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 rest2
Plasma copeptin concentration
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.3
Plasma osmolality
mOsm/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.4
Blood glucose
mg/dL
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.Sponsors and contacts
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Source ClinicalTrials.gov