Impaired ThermoregulationNCT02814188
Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
A study testing Carbohydrate Beverage in people with Impaired Thermoregulation, run by Old Dominion University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Thermoregulation
- What is being tested?
- Carbohydrate Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be currently running ≥20 miles per week
- Have a projected 5-km maximal effort running time between 16:00-23:00 minutes
Who cannot join
- Any gastrointestinal disorders that cause swallowing problems or frequent nausea/vomiting
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Laboratory
Norfolk, Virginia, 23529
About this study
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.
- Conditions
- Impaired Thermoregulation
- Being tested
- Carbohydrate Beverage, Placebo Beverage
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate BeverageOther
750 ml of a 13.5% carbohydrate (sucrose) beverage
Placebo BeverageOther
750 ml of an artificially-sweetened beverage
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Beverage | Experimental | Not described Receives: Other: Carbohydrate Beverage |
| Placebo Beverage | Placebo comparator | Not described Receives: Other: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Body Temperature
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.
Measured: 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 outcomes (3)
Thermal Sensation Scale
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.
Measured: 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
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.
Measured: 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
These ratings will be collected during a 60 minute rest period and at 1-km intervals during a 5-km run.
Measured: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired ThermoregulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wilson, PhD, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814188
- Sponsor's protocol ID
- 892213-3
- Status last verified
- Dec 2017
- First submitted
- 20 Jun 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
- ClinicalTrials.gov ID
- NCT02814188
- Acronym / sponsor ID
- 892213-3
- Conditions
- Impaired Thermoregulation
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Beverage | Experimental | Other: Carbohydrate Beverage |
| Placebo Beverage | Placebo comparator | Other: Placebo Beverage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be currently running ≥20 miles per week
- Have a projected 5-km maximal effort running time between 16:00-23:00 minutes
Key exclusion criteria (1 listed)
- Any gastrointestinal disorders that cause swallowing problems or frequent nausea/vomiting
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 |
|---|---|---|
| Carbohydrate Beverage750 ml of a 13.5% carbohydrate (sucrose) beverage | Other | Carbohydrate Beverage |
| Placebo Beverage750 ml of an artificially-sweetened beverage | Other | Placebo Beverage |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Beverage in people with Impaired Thermoregulation, run by Old Dominion University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 Dec 2017.