- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814188
Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
December 13, 2017 updated by: Patrick Wilson, PhD, Old Dominion University
Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous studies to elicit a thermic effect and increase core body temperature after ingestion.
Carbohydrate foods and supplements are commonly consumed prior to endurance running competition, including situations where an athlete's ability to dissipate body heat is compromised.
Thus, there is some potential for pre-exercise carbohydrate ingestion to have a deleterious effect on body heat regulation in hot and humid environments.
Thus, this projects aims to study the effects of pre-exercise carbohydrate ingestion on core body temperature, perceived thermal stress, and perceived exertion during high-intensity running.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
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 Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Human Performance Laboratory
-
-
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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be currently running ≥20 miles per week
- Have a projected 5-km maximal effort running time between 16:00-23:00 minutes
Exclusion Criteria:
- Any gastrointestinal disorders that cause swallowing problems or frequent nausea/vomiting
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Beverage
|
750 ml of an artificially-sweetened beverage
|
Experimental: Carbohydrate Beverage
|
750 ml of a 13.5% carbohydrate (sucrose) beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core Body Temperature
Time Frame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
Core body temperature will be measured with a ingestible pill thermometer.
Readings will be taken during a 60 minute rest period and at 1-km intervals during a 5-km run.
|
80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thermal Sensation Scale
Time Frame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
The Thermal Sensation Scale is a 0-8 numerical rating scale with descriptors of "unbearably cold" at 0, "neutral" at 4, and "unbearably hot" at 8.
These ratings will be collected during a 60 minute rest period and at 1-km intervals during a 5-km run.
|
80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
Feeling Scale
Time Frame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
The Feeling Scale is a bipolar numerical rating scale ranging from -5 to +5, with descriptors of "very bad" at -5, "neutral" at 0, and "very good" at +5.
These ratings will be collected during a 60 minute rest period and at 1-km intervals during a 5-km run.
|
80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
Rating of Perceived Exertion
Time Frame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
These ratings will be collected during a 60 minute rest period and at 1-km intervals during a 5-km run.
|
80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
|
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
June 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimate)
June 27, 2016
Study Record Updates
Last Update Posted (Actual)
December 15, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 892213-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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