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NCT Number: NCT07646990

Carbohydrate or Protein Drinks Before Exercise in the Heat

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. high-carbohydrate pre-exercise drink impact metabolism and body temperature responses during a treadmill walking in the heat? 2. Does a high-protein or high-carbohydrate drink change oxygen use and heat production during treadmill walking in the heat?

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Key information

Conditions

Heat Stress Behavior Diet Induced Thermogenesis Heat Stress Disorders Motor Activity Protein Consumption Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Protein shake

Dietary Supplement

22 oz of a beverage containing 320 kilocalories (60g protein, 6g fat, 8g carbohydrate).

Carbohydrate shake

Dietary Supplement

22oz of a carbohydrate drink containing 320 kilocalories (75g carbohydrate, 3g protein, <1g fat)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett R Ely, PhD

CONTACT

[email protected]

401-865-2632

Margaret Morrissey-Basler, PhD

CONTACT

[email protected]

401-865-1209

Sponsors and collaborators

Lead sponsor

Providence College

Other

Registry information

Official study title

The Impact of Pre-Exercise Meal Composition on Metabolic Heat Production and Thermal Strain During Exercise in a Hot Environment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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