HydrationCARB-HEATNCT07658820
The Role of Carbohydrate Blends and Electrolytes on Physical and Mental Performance During Cycling in the Heat
A study testing Carbohydrate Milk Permeate sports drink, 6% Sports drink and Low-Carbohydrate Milk Permeate sports drink in people with Hydration and Dehydration (Physiology), run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration, Dehydration (Physiology), Performance
- What is being tested?
- Carbohydrate Milk Permeate sports drink, 6% Sports drink and Low-Carbohydrate Milk Permeate sports drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and injury free (muscle, skeletal) for greater than 2 months
- Active cyclists who train at least 3 times per week
- Body mass index (BMI) range of 18.5-30 kg/m2
- VO₂max ≥ 51 mL/kg/min for male participants
- VO₂max ≥ 45 mL/kg/min for female participants
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
850 Phoenix Bioscience Core
Phoenix, Arizona, 85004
Shannon Wilson, PhD, 602-555-5555, clinicalresearchservices@asu.edu
Stavros Kavouras, PhD
About this study
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:
- 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.
- Conditions
- Hydration, Dehydration (Physiology), Performance
- Being tested
- Water (Placebo), Carbohydrate Milk Permeate sports drink, 6% Sports drink, Low-Carbohydrate Milk Permeate sports drink
- Keywords
- exercise in the heat, cognitive performance
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water (Placebo)Dietary supplement
Flavor water
Carbohydrate Milk Permeate sports drinkDietary supplement
4.4% carbohydrate sports drink
6% Sports drinkDietary supplement
Gatorade with 6% carbohydrate content
Low-Carbohydrate Milk Permeate sports drinkDietary supplement
2.2% Carbohydrate Milk Permeate sports drink
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | no caloric, no sodium containing flavor water Receives: Dietary Supplement: Water (Placebo) |
| Carbohydrate Milk Permeate sports drink | Experimental | GoodSport sports drink Receives: Dietary Supplement: Carbohydrate Milk Permeate sports drink |
| Traditional Sports drink with 6% carbs | Experimental | Gatorade sports drink Receives: Dietary Supplement: 6% Sports drink |
| Low Carbohydrate Milk Permeate sports drink | Experimental | LowCarb GoodSport sports drink Receives: Dietary Supplement: Low-Carbohydrate Milk Permeate sports drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion of 5 kilometer cycling time trial
cycling performance expressed as time to completion.
Measured: Five minutes after completion of the two-hour cycling protocol
Psycho-motor Vigilance test
Psycho-motor Vigilance test measured by reaction time in milliseconds
Measured: Five minutes after completion of the 5-kilometer cycling test
Secondary outcomes (2)
Plasma Osmolality
Plasma osmolality
Measured: 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.
Carbohydrate oxidation rate during exercise
Carbohydrate oxidation rate during 2-h steady-state cycling exercise
Measured: At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kavouras, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658820
- Sponsor's protocol ID
- AWD00041609
- Acronym
- CARB-HEAT
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Carbohydrate Blends and Electrolytes on Physical and Mental Performance During Cycling in the Heat
- ClinicalTrials.gov ID
- NCT07658820
- Acronym / sponsor ID
- CARB-HEAT / AWD00041609
- Conditions
- Hydration, Dehydration (Physiology), Performance
- Keywords
- exercise in the heat, cognitive performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Water (Placebo)no caloric, no sodium containing flavor water |
| Carbohydrate Milk Permeate sports drink | Experimental | Dietary Supplement: Carbohydrate Milk Permeate sports drinkGoodSport sports drink |
| Traditional Sports drink with 6% carbs | Experimental | Dietary Supplement: 6% Sports drinkGatorade sports drink |
| Low Carbohydrate Milk Permeate sports drink | Experimental | Dietary Supplement: Low-Carbohydrate Milk Permeate sports drinkLowCarb GoodSport sports drink |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy and injury free (muscle, skeletal) for greater than 2 months
- Active cyclists who train at least 3 times per week
- Body mass index (BMI) range of 18.5-30 kg/m2
- VO₂max ≥ 51 mL/kg/min for male participants
- VO₂max ≥ 45 mL/kg/min for female participants
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water (Placebo)Flavor water | Dietary supplement | Placebo |
| Carbohydrate Milk Permeate sports drink4.4% carbohydrate sports drink | Dietary supplement | Carbohydrate Milk Permeate sports drink |
| 6% Sports drinkGatorade with 6% carbohydrate content | Dietary supplement | Traditional Sports drink with 6% carbs |
| Low-Carbohydrate Milk Permeate sports drink2.2% Carbohydrate Milk Permeate sports drink | Dietary supplement | Low Carbohydrate Milk Permeate sports drink |
Primary outcome
Time to completion of 5 kilometer cycling time trial
Time frame: Five minutes after completion of the two-hour cycling protocol
cycling performance expressed as time to completion.
Psycho-motor Vigilance test
Time frame: Five minutes after completion of the 5-kilometer cycling test
Psycho-motor Vigilance test measured by reaction time in milliseconds
2 secondary outcomes
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.
Carbohydrate oxidation rate during exercise
Time frame: At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Milk Permeate sports drink, 6% Sports drink and Low-Carbohydrate Milk Permeate sports drink in people with Hydration and Dehydration (Physiology), run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sajjad Rezaei, MS (515-441-4904, srezaei8@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to completion of 5 kilometer cycling time trial (time frame: Five minutes after completion of the two-hour cycling protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.