Carbohydrate or Protein Drinks Before Exercise in the Heat

NCT07646990 | Not Yet Recruiting

• 1 other identifier: FY26-66
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.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

Keywords

high protein diet, exercise, hot environment

Outcome Measures

Primary Outcomes (1)

• 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 during 60 minutes of steady state exercise in 36C, 40% humidity

Secondary Outcomes (4)

• Core Temperature

  Measured at rest and following 60 minutes of exercise in a warm (36C, 40% humidity) environment

• Urinary NGAL (ng/mL)

  Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)

• Urine Specific Gravity (USG)

  Measured before and after 60 minutes of exercise in a warm (36C, 40%RH) environment.

• Proteinuria

  Following 60 minutes of exercise in a warm environment (36C, 40% relative humidity)

Study Arms (2)

High Protein

EXPERIMENTAL

A 22-oz high-protein, low-carbohydrate shake (chocolate flavor), given 60-90 minutes before exercise.

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

Dietary Supplement: Carbohydrate shake

Interventions

Protein shake DIETARY_SUPPLEMENT

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

High Protein

Carbohydrate shake DIETARY_SUPPLEMENT

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

High Carbohydrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to walk or run up to 5 mph on a treadmill
• Able to consume products containing dairy (no allergy or dietary restrictions)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Providence College: lead

MeSH Terms

Conditions

Heat Stress Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Central Study Contacts

Brett R Ely, PhD

CONTACT

401-865-2632; bely@providence.edu

Margaret Morrissey-Basler, PhD

CONTACT

401-865-1209; mmorri17@providence.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Health Sciences

Model Details: Double-blind crossover design

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 15, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share