ClinicalTrials.gg
Not yet recruitingNCT07658820CARB-HEATUpdated Jun 22, 2026

The Role of Carbohydrate Blends and Electrolytes on Physical and Mental Performance During Cycling in the Heat

An interventional study of Water (Placebo) and Carbohydrate Milk Permeate sports drink in Hydration, Dehydration (Physiology) and Performance, sponsored by Arizona State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Arizona State University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The aim of the present study is to evaluate the effectiveness of a milk permeate-based sports drink on hydration, carbohydrate oxidation, exercise performance, vigilance, and reaction time in the heat. We anticipate that the milk permeate, with 44 g per liter and high sodium and potassium, will lead to better hydration, energy delivery, and physical and cognitive performance.

Read the detailed description

EXPERIMENTAL PROTOCOL Each subject will complete five trials (one familiarization and four experimental), consisting of computer-based vigilance and reaction time tests (VIG/RT) administered before and after approximately 2 hours of cycling in a warm environment (90°F, 25-35% relative humidity). Each trial will be identical, with the only difference being the type of drink consumed during each trial. The beverages are commercially available products and are not considered investigational products under FDA regulations.

The first trial will be a familiarization trial, during which participants will complete the VIG/RT tests and cycling protocol exactly as performed in the experimental trials, but no biological samples will be collected. The remaining trials will be completed in randomized order, and the drink consumed will be:

A) Placebo (flavored water) B) GoodSport® (milk-permeate, lactose-free sports drink) C) Gatorade® (traditional sports drink) D) Low-Carb GoodSport® During the experiments, core body temperature, heart rate, skin temperature, urine samples, and expiratory gases will be collected. Blood samples will be collected using an intravenous catheter placed in an antecubital vein (see protocol figure on the next page). During the familiarization trial, no samples will be collected.

INFORMED CONSENT AND BASELINE ASSESSMENT During the initial visit, subjects will read the consent form, discuss any concerns, and have questions addressed. After signing the consent form, participants will have 20 minutes to complete the medical health history, PAR-Q questionnaire, and Ingestible Core Body Temperature Sensor Contraindication Form in person on paper.

If the volunteer is deemed eligible, height, weight, and body composition will be assessed on site using a bioelectrical impedance analyzer, and the procedure will take approximately five minutes.

Participants will then complete a standard graded exercise test (GXT) performed on a cycle ergometer. Performance data (e.g., power output) obtained from this test will be used to determine the resistance applied to the cycle ergometer during the experimental trials (description provided below). During this test, the investigators will also assess maximal oxygen uptake (VO₂max) via indirect calorimetry to evaluate aerobic capacity.

Once testing is completed, the experimental trials will be scheduled. Participants will receive a food diary form to record all food and fluid intake on the day before each trial, and dietary restrictions or allergies will be documented. Participants will be asked to replicate this intake for subsequent visits. Frozen meals will be provided for consumption as dinner before the first experimental trial. Additional meals will be provided after each experimental visit.

EXPERIMENTAL PROCESSES Subjects will ingest an individually calibrated telemetric temperature pill (e-Celsius®, France) on the evening preceding each trial to avoid interaction with fluid ingestion during testing. Subjects will report to the laboratory after at least 10 hours of fasting from food and beverages other than water, and a urine sample will be collected to verify adequate hydration status.

The urine sample will be analyzed for urine specific gravity (USG). If USG is below 1.020, indicating adequate hydration, the protocol will proceed. If USG is greater than 1.029, the trial will be canceled and rescheduled. If USG is between 1.020 and 1.029, the volunteer will consume 16 oz of water, and another urine sample will be collected within 30 minutes. The trial will be canceled and rescheduled unless USG is below 1.020 at the subsequent sample or unless the volunteer is unable to provide an additional sample.

At the start of each experimental trial, subjects will consume a light breakfast, after which body composition will be assessed using a bioelectrical impedance scale. Subjects will then complete the vigilance and reaction time tests. After completion of the tests, an intravenous catheter will be placed in an antecubital vein, and a baseline blood sample will be collected. Subjects will then void the bladder, and body weight will be measured. Once these procedures are completed, subjects will be positioned on the cycle ergometer.

Cycling Endurance Exercise Performance Each trial includes 120 minutes of cycling at 70% of VO₂max, followed by a 5-km time trial. A relative beverage volume of 15 mL/kg/h will be provided. The total beverage volume will be divided into aliquots and administered every 10 minutes during the 120-minute exercise period.

At the end of the 120-minute exercise bout, subjects will consume an additional beverage bolus before the 5-km time trial (see Figure 1 for drink timing), and another bolus will be consumed immediately before the post-exercise vigilance and reaction time (VIG/RT) tests. After completion of the tests, body composition will again be assessed using a bioelectrical impedance scale.

At regular intervals throughout the exercise protocol, body weight, blood samples, respiratory gases, and perceptual measures will be collected. See the study schematic provided below for specific measurement time points.

02

Conditions studied

  • Hydration
  • Dehydration (Physiology)
  • Performance

Browse trials for

Keywords

  • exercise in the heat
  • cognitive performance
03

In context

Dehydration

201 studies on the registry are indexed under Dehydration; 28 are open to participants now.

This study's planned enrollment of 14 is below the median of 43 across 145 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy and injury free (muscle, skeletal) for greater than 2 months
  • Active cyclists who train at least 3 times per week
  • (BMI) range of 18.5-30 kg/m2
  • VO₂max ≥ 51 mL/kg/min for male participants
  • VO₂max ≥ 45 mL/kg/min for female participants

Exclusion criteria

Exclusion Criteria:

  • Taking medicine influences the cardiovascular system
  • non-steroidal anti-inflammatory drugs during the last week
  • Cancer Diagnosis during the last 5 years
  • Current Pregnancy
  • History of renal disease, hypertension, obstructive gastrointestinal tract disease, disorders or impairment of the gag reflex, previous gastrointestinal surgery
  • History of heat stroke
  • Use of testosterone therapy
  • Adults who are unable to consent (impaired decision-making capacity)
  • Adults having Felinization of the esophagus
  • Adults who will undergo Nuclear Magnetic Resonance (NMR) or MRI scanning within 3 days of swallowing a temperature sensitive pills
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
14 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    no caloric, no sodium containing flavor water

    Dietary Supplement: Water (Placebo)

  • Experimental
    Carbohydrate Milk Permeate sports drink

    GoodSport sports drink

    Dietary Supplement: Carbohydrate Milk Permeate sports drink

  • Experimental
    Traditional Sports drink with 6% carbs

    Gatorade sports drink

    Dietary Supplement: 6% Sports drink

  • Experimental
    Low Carbohydrate Milk Permeate sports drink

    LowCarb GoodSport sports drink

    Dietary Supplement: Low-Carbohydrate Milk Permeate sports drink

Interventions

  • Dietary supplementWater (Placebo)

    Flavor water

  • Dietary supplementCarbohydrate Milk Permeate sports drink

    4.4% carbohydrate sports drink

  • Dietary supplement6% Sports drink

    Gatorade with 6% carbohydrate content

  • Dietary supplementLow-Carbohydrate Milk Permeate sports drink

    2.2% Carbohydrate Milk Permeate sports drink

06

What researchers measure

Primary outcomes

  1. Time to completion of 5 kilometer cycling time trial

    cycling performance expressed as time to completion.

    Time frame: Five minutes after completion of the two-hour cycling protocol

  2. Psycho-motor Vigilance test

    Psycho-motor Vigilance test measured by reaction time in milliseconds

    Time frame: Five minutes after completion of the 5-kilometer cycling test

Secondary outcomes

  1. Plasma Osmolality

    Plasma osmolality

    Time frame: Plasma osmolality at 0, 30, 60, 90, and 120 minutes of the 2-hour steady cycling, at the end of the 5-kilometer cycling time trial, and within 2 minutes after the cognitive test.

  2. Carbohydrate oxidation rate during exercise

    Carbohydrate oxidation rate during 2-h steady-state cycling exercise

    Time frame: At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Mar 2027, 9 months later.

Of 65 non-industry interventional studies with no phase under Dehydration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 9 months is above that.

Counting every sponsor, half of 73 studies reached it within 9 months; a quarter within 5 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 22, 2026
StartEst.
Jun 22, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Jun 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07658820
Responsible party
Stavros Kavouras (Professor, Arizona State University) — Principal investigator
First posted
Jun 22, 2026
Start date
Jun 22, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Sajjad Rezaei, MS
Contact
srezaei8@asu.edu
515-441-4904

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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