An interventional study of Carbohydrate Dissolvable Strip and Carbohydrate Mouth Rinse in Nutrition, Healthy, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by University of Georgia · Not applicable, Interventional, and Other
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.
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:
Hypotheses:
University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
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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
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
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
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.
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.
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Percent change from baseline/start time to approximately 1.5 hours
Body Weight Pre-to-Post Time Trial
Body weight (kg)
Time frame: 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.
Time frame: 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.
Time frame: At the end of each testing visit (days 1-3)
Five-Point Just-About-Right Scale
The Five-Point Just-About-Right Scale will be used to measure the appropriateness of each treatment according to consumer perception. The scale is measured from 1 to 5. Higher ratings indicate strong perceptions of the treatment.
Time frame: At the end of each testing visit (days 1-3)
Consumer Product Questionnaire
A Consumer Product Questionnaire will assess various consumer experiences and perceptions regarding the dissolvable strip and Mouth rinse treatments. This questionnaire contains "yes or no" questions regarding nutrition supplementation and asks about consumer experiences if any past supplements have been used.
Time frame: At the end of the final testing visit (day 3 of intervention)
Net Promotor Score Rating
A Net Promoter Score Questionnaire will be used to measure satisfaction by asking how likely it is that consumers would recommend the dissolvable strip product to a friend or colleague. The scale used goes from 1 to 10; the higher the score indicates an increased likeliness of recommending the product to a friend or colleague.
Time frame: At the end of the testing visit in which the participants received the dissolvable strip (day 1, 2, or 3)
New Product Questionnaire Rating
A New Product Questionnaire will be used to measure various aspects such as market needs, product features, customer preferences, usage patterns, competitor analyses, pricing, purchase intent, and improvement suggestions to gather insights and feedback about the dissolvable strip product. The scale used goes from 1 to 5, and the greater the number, the worse the feeling about the product.
Time frame: At the end of the testing visit in which the participants received the dissolvable strip (day 1, 2, or 3)
Plan to share: No
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