- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646990
Carbohydrate or Protein Drinks Before Exercise in the Heat
June 10, 2026 updated by: Brett Romano Ely, Providence College
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?
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brett R Ely, PhD
- Phone Number: 401-865-2632
- Email: bely@providence.edu
Study Contact Backup
- Name: Margaret Morrissey-Basler, PhD
- Phone Number: 401-865-1209
- Email: mmorri17@providence.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able to walk or run up to 5 mph on a treadmill
- Able to consume products containing dairy (no allergy or dietary restrictions)
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Protein
A 22-oz high-protein, low-carbohydrate shake (chocolate flavor), given 60-90 minutes before exercise.
|
22 oz of a beverage containing 320 kilocalories (60g protein, 6g fat, 8g carbohydrate).
|
|
Active Comparator: High Carbohydrate
A 22-oz, high-carbohydrate, low-protein & fat shake (chocolate flavor), given 60-90 minutes before exercise
|
22oz of a carbohydrate drink containing 320 kilocalories (75g carbohydrate, 3g protein, <1g fat)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Measured during 60 minutes of steady state exercise in 36C, 40% humidity
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Temperature
Time Frame: Measured at rest and following 60 minutes of exercise in a warm (36C, 40% humidity) environment
|
Internal temperature change during exercise
|
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)
|
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.
|
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.
|
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 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)
|
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.
|
Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 4, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
June 2, 2026
First Submitted That Met QC Criteria
June 10, 2026
First Posted (Actual)
June 15, 2026
Study Record Updates
Last Update Posted (Actual)
June 15, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FY26-66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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