NCT02814188

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

June 20, 2016

Last Update Submit

December 13, 2017

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)

Study Arms (2)

Carbohydrate Beverage

EXPERIMENTAL
Other: Carbohydrate Beverage

Placebo Beverage

PLACEBO COMPARATOR
Other: Placebo Beverage

Interventions

750 ml of a 13.5% carbohydrate (sucrose) beverage

Carbohydrate Beverage

750 ml of an artificially-sweetened beverage

Placebo Beverage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be currently running ≥20 miles per week
  • Have a projected 5-km maximal effort running time between 16:00-23:00 minutes

You may not qualify if:

  • Any gastrointestinal disorders that cause swallowing problems or frequent nausea/vomiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Exercise Science

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 27, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations