Heat StressNCT07646990
Carbohydrate or Protein Drinks Before Exercise in the Heat
A study testing Protein shake and Carbohydrate shake in people with Heat Stress and Diet Induced Thermogenesis, run by Providence College.
Trial summary
This project examines whether consuming a high-protein or high-carbohydrate beverage before exercise in the heat impacts metabolism and heat balance during exercise, with the following research questions: 1. Does a high-protein vs. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Diet Induced Thermogenesis, Protein Consumption
- What is being tested?
- Protein shake and Carbohydrate shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2026to May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to walk or run up to 5 mph on a treadmill
- Able to consume products containing dairy (no allergy or dietary restrictions)
Who cannot join
- Following a diet that excludes any macronutrient group (low-carb or low-fat)
- Diagnosed cardiovascular or metabolic diseases (hypertension, diabetes)
- Diagnosed heat illness in past 3 months (heat exhaustion, heat stroke)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Pre-Exercise Meal Composition on Metabolic Heat Production and Thermal Strain During Exercise in a Hot Environment
This project examines whether consuming a high-protein or high-carbohydrate beverage before exercise in the heat impacts metabolism and heat balance during exercise, with the following research questions:
- Does a high-protein vs. high-carbohydrate pre-exercise drink impact metabolism and body temperature responses during a treadmill walking in the heat?
- Does a high-protein or high-carbohydrate drink change oxygen use and heat production during treadmill walking in the heat?
- Conditions
- Heat Stress, Diet Induced Thermogenesis, Protein Consumption
- Being tested
- Protein shake, Carbohydrate shake
- Keywords
- high protein diet, exercise, hot environment
- Medical subject headings
- Heat Stress Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein shakeDietary supplement
22 oz of a beverage containing 320 kilocalories (60g protein, 6g fat, 8g carbohydrate).
Carbohydrate shakeDietary supplement
22oz of a carbohydrate drink containing 320 kilocalories (75g carbohydrate, 3g protein, <1g fat)
| Study group | Role | What they receive |
|---|---|---|
| High Protein | Experimental | A 22-oz high-protein, low-carbohydrate shake (chocolate flavor), given 60-90 minutes before exercise. Receives: Dietary Supplement: Protein shake |
| High Carbohydrate | Active comparator | A 22-oz, high-carbohydrate, low-protein \& fat shake (chocolate flavor), given 60-90 minutes before exercise Receives: Dietary Supplement: Carbohydrate shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Heat Production
Heat production measured during exercise at 6 watts/kg, calculated based on oxygen consumption and carbon dioxide production during exercise (indirect calorimetry)
Measured: Measured during 60 minutes of steady state exercise in 36C, 40% humidity
Secondary outcomes (4)
Core Temperature
Internal temperature change during exercise
Measured: Measured at rest and following 60 minutes of exercise in a warm (36C, 40% humidity) environment
Urinary NGAL (ng/mL)
Measured after exercise in high-protein and high-carbohydrate trials, NGAL (neutrophil-gelatinase associated lipocalin; a marker of acute kidney injury) will be measured in urine samples in each trial to assess kidney function.
Measured: Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)
Urine Specific Gravity (USG)
Measured in urine samples provided before and after exercise, USG will be used as a marker of urine concentration and hydration status with each intervention.
Measured: Measured before and after 60 minutes of exercise in a warm (36C, 40%RH) environment.
Proteinuria
Measured after exercise in high-protein and high-carbohydrate trials, total protein content will be measured in urine samples in each trial to assess kidney function.
Measured: Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start4 Jun 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Romano Ely, Providence College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646990
- Sponsor's protocol ID
- FY26-66
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 15 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-Exercise Meal Composition on Metabolic Heat Production and Thermal Strain During Exercise in a Hot Environment
- ClinicalTrials.gov ID
- NCT07646990
- Acronym / sponsor ID
- FY26-66
- Conditions
- Heat Stress, Diet Induced Thermogenesis, Protein Consumption
- Keywords
- high protein diet, exercise, hot environment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Providence CollegeUniversity, hospital or other
- Study start
- 4 Jun 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 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.
This project examines whether consuming a high-protein or high-carbohydrate beverage before exercise in the heat impacts metabolism and heat balance during exercise, with the following research questions:
- Does a high-protein vs. high-carbohydrate pre-exercise drink impact metabolism and body temperature responses during a treadmill walking in the heat?
- Does a high-protein or high-carbohydrate drink change oxygen use and heat production during treadmill walking in the heat?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind crossover design
| Arm | Type | Receives |
|---|---|---|
| High Protein | Experimental | Dietary Supplement: Protein shakeA 22-oz high-protein, low-carbohydrate shake (chocolate flavor), given 60-90 minutes before exercise. |
| High Carbohydrate | Active comparator | Dietary Supplement: Carbohydrate shakeA 22-oz, high-carbohydrate, low-protein \& fat shake (chocolate flavor), given 60-90 minutes before exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to walk or run up to 5 mph on a treadmill
- Able to consume products containing dairy (no allergy or dietary restrictions)
Key exclusion criteria (3 listed)
- Following a diet that excludes any macronutrient group (low-carb or low-fat)
- Diagnosed cardiovascular or metabolic diseases (hypertension, diabetes)
- Diagnosed heat illness in past 3 months (heat exhaustion, heat stroke)
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 |
|---|---|---|
| Protein shake22 oz of a beverage containing 320 kilocalories (60g protein, 6g fat, 8g carbohydrate). | Dietary supplement | High Protein |
| Carbohydrate shake22oz of a carbohydrate drink containing 320 kilocalories (75g carbohydrate, 3g protein, <1g fat) | Dietary supplement | High Carbohydrate |
Primary outcome
Metabolic Heat Production
Time frame: Measured during 60 minutes of steady state exercise in 36C, 40% humidity
Heat production measured during exercise at 6 watts/kg, calculated based on oxygen consumption and carbon dioxide production during exercise (indirect calorimetry)
4 secondary outcomes
Core Temperature
Time frame: Measured at rest and following 60 minutes of exercise in a warm (36C, 40% humidity) environment
Urinary NGAL (ng/mL)
Time frame: Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)
Urine Specific Gravity (USG)
Time frame: Measured before and after 60 minutes of exercise in a warm (36C, 40%RH) environment.
Proteinuria
Time frame: Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)
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 15 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.
Questions about this trial
What is this clinical trial studying?
A study testing Protein shake and Carbohydrate shake in people with Heat Stress and Diet Induced Thermogenesis, run by Providence College.
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 2 inclusion and 3 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Brett R Ely, PhD (401-865-2632, bely@providence.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Heat Production (time frame: Measured during 60 minutes of steady state exercise in 36C, 40% humidity). 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 15 Jun 2026.