Carbohydrates and Running Performance

NCT06742398 | Completed

• 1 other identifier: PROJECT00005235
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Carbohydrates serve as the body's primary energy source during intense exercise, and consuming carbohydrates during exercise has been shown to improve exercise performance. Previous research has shown that the presence of carbohydrates in the mouth activates sweet taste receptors on the tongue, which signal the brain to increase neural activation in areas associated with motor functioning, sensory perception, and reward centers during exercise through this CPR. The primary objective of this intervention is to establish how carbohydrates delivered in different forms (MR versus dissolvable strip (DS)) affect running performance during a 12.8km running TT.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (8)

• Completion Times

  Measured by the time it takes from the beginning of the time trial (0.0 km) to finish the 12.8 km distance (minutes and seconds).

  Baseline/start time to approximately 1.5 hours

• Percent Change in Completion Time from Control

  Measured by subtracting the completion time of the experimental and active comparator treatments from the control/sham comparator and dividing by the control/sham comparator, then multiplying by 100 to convert to a percentage (percent change in completion time from control).

  Baseline/start time to approximately 1.5 hours

• Mile Pace Splits During the Time Trial

  Measured by the time it takes to complete each individual 12.5% increment of the total 12.8 km time trial (minutes and seconds).

  Baseline/start time to approximately 1.5 hours

• Blood Lactate Levels

  The blood lactate concentration immediately before beginning and after completion of the time trial at visits 2-4 (mmol/L).

  Baseline to approximately 1.5 hours

• Ratings of Perceived Exertion

  The Borg's Rating of Perceived Exertion scale will be used to measure self-reported perceived exertion (RPE) ratings. The sale minimum is 6, and the maximum is 20. Higher scores indicate higher feelings of exertion.

  Baseline/start time to approximately 1.5 hours

• Maximum Heart Rate

  A continuous heart rate monitor (Polar H9 Heart Rate Sensor) will measure maximum heart rate (beats per minute).

  Baseline/start time to approximately 1.5 hours

• Change in Time Trial Heart Rate Values

  A continuous heart rate monitor (Polar H9 Heart Rate Sensor) will be used to measure heart rate throughout the time trial (beats per minute).

  Change from baseline/start time to approximately 1.5 hours

• Percent Change in Blood Lactate Pre-to-Post Time Trial

  Measured by subtracting post-blood lactate from pre-blood lactate and dividing by pre-blood lactate, then multiplying by 100 to convert to a percentage (percent change in lactate).

  Percent change from baseline/start time to approximately 1.5 hours

Secondary Outcomes (3)

• Body Weight Pre-to-Post Time Trial

  Baseline/start time to approximately 1.5 hours

• Acute Dietary Intake

  Day before visit 2, Day before visit 3, Day before visit 4

• Subjective Sensory Feelings by Treatment

  At the end of each testing visit (days 1-3)

Other Outcomes (4)

• Five-Point Just-About-Right Scale

  At the end of each testing visit (days 1-3)

• Consumer Product Questionnaire

  At the end of the final testing visit (day 3 of intervention)

• Net Promotor Score Rating

  At the end of the testing visit in which the participants received the dissolvable strip (day 1, 2, or 3)

Study Arms (3)

Carbohydrate Mouth Rinse

ACTIVE COMPARATOR

Subjects will be instructed to complete the 12.8 km time trial (TT) as quickly as possible. They will be able to adjust the speed on the treadmill throughout the TT but will have no knowledge of what speed they are actually running at. The researcher will monitor the progress of the TT, and the completion time will be recorded. The carbohydrate mouth rinse treatment will be given just before the start of the TT and every 12.5% of the TT, but not after the completion of the TT.

Other: Carbohydrate Mouth Rinse

Water Mouth Rinse

SHAM COMPARATOR

Subjects will be instructed to complete the 12.8 km time trial (TT) as quickly as possible. They will be able to adjust the speed on the treadmill throughout the TT but will have no knowledge of what speed they are actually running at. The researcher will monitor the progress of the TT, and the completion time will be recorded. The water mouth rinse treatment will be given just before the start of the TT and every 12.5% of the TT, but not after the completion of the TT.

Other: Water Mouth Rinse

Carbohydrate Dissolvable Strip

EXPERIMENTAL

Subjects will be instructed to complete the 12.8 km time trial (TT) as quickly as possible. They will be able to adjust the speed on the treadmill throughout the TT but will have no knowledge of what speed they are actually running at. The researcher will monitor the progress of the TT, and the completion time will be recorded. The carbohydrate dissolvable strip treatment will be given just before the start of the TT and every 12.5% of the TT, but not after the completion of the TT.

Other: Carbohydrate Dissolvable Strip

Interventions

Carbohydrate Dissolvable Strip OTHER

Participants are provided with a carbohydrate dissolvable strip for every 12.5% of the time trial that is completed (calculated based on the distance covered). The carbohydrate dissolvable strip (Innsol Health Corp.) is primarily composed of sucrose and glucose; however, the full ingredient list includes pullulan, mannitol, menthol, hydroxyl propyl methyl cellulose, eucalyptol, polysorbate 80, glyceryl oleate, purified water.

Carbohydrate Dissolvable Strip

Carbohydrate Mouth Rinse OTHER

Participants are provided with a carbohydrate mouth rinse for every 12.5% of the time trial that is completed (calculated based on the distance covered). The sucrose solution will consist of 64g of sucrose dissolved in 1000 mL of water, with a bolus of 25 mL being used for each mouth rinse. Each mouth rinse solution will have 2mL of red food dye FD\&C Red No. 40 to ensure the same sensory response through appearance.

Carbohydrate Mouth Rinse

Water Mouth Rinse OTHER

Participants are provided with a water mouth rinse for every 12.5% of the time trial that is completed (calculated based on the distance covered). The water solution will consist of 1000 mL of water, with a bolus of 25 mL being used for each mouth rinse. Each mouth rinse solution will have 2mL of red food dye FD\&C Red No. 40 to ensure the same sensory response through appearance.

Water Mouth Rinse

Eligibility Criteria

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

You may qualify if:

• years old
• Male or Female
• Normal body mass index (BMI) between 18.0-24.9kg/m2
• All subjects will be endurance-trained athletes who participate in training on a regular basis (≥4 sessions per week for at least 1 hour per session of aerobic/endurance exercise (such as running, cycling, or swimming)
• Women will be tested only during the follicular phase of their menstrual cycle (days 2-9) to control for any fluctuation in hormones
• Individuals aged 35 or older must pass the Physical Activity Readiness Questionnaire (PARQ2)

You may not qualify if:

• Anyone eating a low carbohydrate diet (such as The Zone™ Diet or Atkins™ Diet)
• Changes in current exercise program
• Chronic diseases (including but not limited to type II diabetes, hypertension, hypotension, hyperthyroidism, cardiovascular disease, and cancer)
• Medications that could alter metabolic rate or hydration status
• Supplement use other than fish oil or vitamin/mineral supplements
• Nicotine use
• Pregnancy or nursing
• Donation of blood in the 20 days prior to testing
• A failing result on the Physical Activity Readiness Questionnaire (PARQ2) for those aged 35 or older
• Allergy to red food dye FD\&C Red No. 40

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Study Officials

• Jamie A Cooper, Ph.D.

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Model Details: For the three testing visits (V2-V4), subjects will perform a 12.8 km running TT on a motorized treadmill, with the only difference between visits being the form of treatment. Either a carbohydrate MR solution (called CMR), water MR solution as a control (called WMR), or carbohydrate DS (called DS) will be administered at each visit in a randomized order. Study visits will be separated by at least 5 days, and all visits will take place in the Human Nutrition Lab (HNL) at the University of Georgia in Athens.

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 19, 2024
• Study Start: February 16, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)