Carbohydrates and Running Performance

NCT ID: NCT06742398

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2025-06-01

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.

Detailed Description

This trial will be a randomized, controlled crossover design in humans. There will be four study visits (see Figure 1 below). The first visit (Baseline Visit/V1) will entail signing informed consent documents, anthropometric measurements, familiarization with the MR and DS, and the exercise protocol. 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 CDS) 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.

Specific Aims:

1. To examine the effect of carbohydrates delivered in different forms on running performance.

2. To examine the effect of carbohydrates delivered in different forms on physiologic measures as well as perceived exertion.

Hypotheses:

1. The investigators hypothesize that the carbohydrate-containing MR and DS will result in faster TT performance compared to a water MR (control).

2. The Investigators hypothesize that the carbohydrate-containing DS and MR will elicit higher HR and blood lactate levels (indicating greater levels of intensity) compared to control without significantly increasing RPE during the running TT.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Carbohydrate Mouth Rinse

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.

Group Type: ACTIVE_COMPARATOR

Carbohydrate Mouth Rinse

Intervention Type: 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.

Water Mouth Rinse

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.

Group Type: SHAM_COMPARATOR

Water Mouth Rinse

Intervention Type: 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.

Carbohydrate Dissolvable Strip

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.

Group Type: EXPERIMENTAL

Carbohydrate Dissolvable Strip

Intervention Type: 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.

Interventions

Carbohydrate Dissolvable Strip

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.

Intervention Type: OTHER

Carbohydrate Mouth Rinse

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.

Intervention Type: OTHER

Water Mouth Rinse

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-45 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Jamie Cooper, PhD

Professor and Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie A Cooper, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

University of Georgia

Athens, Georgia, United States

Countries

United States

Other Identifiers

PROJECT00005235

Identifier Type: -

Identifier Source: org_study_id