Nutrition, HealthyNCT06742398
Carbohydrates and Running Performance
A study testing Carbohydrate Dissolvable Strip, Carbohydrate Mouth Rinse and Water Mouth Rinse in people with Nutrition, Healthy, run by University of Georgia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Carbohydrate Dissolvable Strip, Carbohydrate Mouth Rinse and Water Mouth Rinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 1 Jun 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Running Performance in Response to Different Forms of Carbohydrate
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.
Read the 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:
- To examine the effect of carbohydrates delivered in different forms on running performance.
- To examine the effect of carbohydrates delivered in different forms on physiologic measures as well as perceived exertion.
Hypotheses:
- The investigators hypothesize that the carbohydrate-containing MR and DS will result in faster TT performance compared to a water MR (control).
- 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
- Being tested
- Carbohydrate Dissolvable Strip, Carbohydrate Mouth Rinse, Water Mouth Rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Dissolvable StripOther
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 Mouth RinseOther
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 RinseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Carbohydrate Dissolvable Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Percent change from baseline/start time to approximately 1.5 hours
Secondary outcomes (3)
Body Weight Pre-to-Post Time Trial
Body weight (kg)
Measured: Baseline/start time to approximately 1.5 hours
Acute Dietary Intake
One-day food logs will be used to record all foods and beverages consumed the day before testing days.
Measured: Day before visit 2, Day before visit 3, Day before visit 4
Subjective Sensory Feelings by Treatment
Subjective feelings related to the sweetness, saltiness, sourness, bitterness, savories, and pleasantness of intervention food are measured by visual analog scales (mm) and generalized labeled magnitude scales (mm). Both scales are measured from 0-100 mm. Higher ratings indicate higher sensory scores.
Measured: At the end of each testing visit (days 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start16 Feb 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
- Investigators
- Jamie A Cooper, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742398
- Sponsor's protocol ID
- PROJECT00005235
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Running Performance in Response to Different Forms of Carbohydrate
- ClinicalTrials.gov ID
- NCT06742398
- Acronym / sponsor ID
- PROJECT00005235
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- 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.
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:
- To examine the effect of carbohydrates delivered in different forms on running performance.
- To examine the effect of carbohydrates delivered in different forms on physiologic measures as well as perceived exertion.
Hypotheses:
- The investigators hypothesize that the carbohydrate-containing MR and DS will result in faster TT performance compared to a water MR (control).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Mouth Rinse | Active comparator | Other: Carbohydrate Mouth RinseSubjects 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. |
| Water Mouth Rinse | Sham comparator | Other: Water Mouth RinseSubjects 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. |
| Carbohydrate Dissolvable Strip | Experimental | Other: Carbohydrate Dissolvable StripSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 Dissolvable StripParticipants 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. | Other | Carbohydrate Dissolvable Strip |
| Carbohydrate Mouth RinseParticipants 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. | Other | Carbohydrate Mouth Rinse |
| Water Mouth RinseParticipants 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. | Other | Water Mouth Rinse |
Primary outcome
Completion Times
Time frame: Baseline/start time to approximately 1.5 hours
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).
Percent Change in Completion Time from Control
Time frame: Baseline/start time to approximately 1.5 hours
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).
Mile Pace Splits During the Time Trial
Time frame: Baseline/start time to approximately 1.5 hours
Measured by the time it takes to complete each individual 12.5% increment of the total 12.8 km time trial (minutes and seconds).
Blood Lactate Levels
Time frame: Baseline to approximately 1.5 hours
The blood lactate concentration immediately before beginning and after completion of the time trial at visits 2-4 (mmol/L).
Ratings of Perceived Exertion
Time frame: Baseline/start time to approximately 1.5 hours
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.
Maximum Heart Rate
Time frame: Baseline/start time to approximately 1.5 hours
A continuous heart rate monitor (Polar H9 Heart Rate Sensor) will measure maximum heart rate (beats per minute).
Change in Time Trial Heart Rate Values
Time frame: Change from baseline/start time to approximately 1.5 hours
A continuous heart rate monitor (Polar H9 Heart Rate Sensor) will be used to measure heart rate throughout the time trial (beats per minute).
Percent Change in Blood Lactate Pre-to-Post Time Trial
Time frame: Percent change from baseline/start time to approximately 1.5 hours
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).
3 secondary outcomes
Body Weight Pre-to-Post Time Trial
Time frame: Baseline/start time to approximately 1.5 hours
Acute Dietary Intake
Time frame: Day before visit 2, Day before visit 3, Day before visit 4
Subjective Sensory Feelings by Treatment
Time frame: At the end of each testing visit (days 1-3)
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 24 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Jamie A Cooper, Ph.D. principal investigator
University of Georgia
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 Dissolvable Strip, Carbohydrate Mouth Rinse and Water Mouth Rinse in people with Nutrition, Healthy, run by University of Georgia 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 6 inclusion and 10 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 24 Jul 2025. 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?
Completion Times (time frame: Baseline/start time to approximately 1.5 hours). The study lists 8 primary outcomes in all. 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 24 Jul 2025.