Carbohydrate Mouth-rinse on Time Trial PerformanceCHO rinseNCT01527266
Carbohydrate Mouth-rinse
A study testing Carbohydrate drink in people with Carbohydrate Mouth-rinse on Time Trial Performance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Several studies have reported that carbohydrate (CHO) ingestion can improve performance during exercise of short duration (less than 60 min). However, there is no apparent metabolic explanation for this observation because endogenous CHO stores should not be a limiting factor during short duration exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Mouth-rinse on Time Trial Performance
- What is being tested?
- Carbohydrate drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Jan 2013
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Male
- 18 - 35 years of age
- Endurance cycling trained (≥ 3 sessions of endurance exercise per week)
- VO2 max ≥ 50 ml/kg/min
- Training history of more than one year of ≥ 3 sessions of endurance cycling exercise per week
- BMI < 25 kg/m2
Who cannot join
- Use of medication
- Smoking
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
About this study
Official title: The Impact of a Sucrose Mouth-rinse in the Fasted and Fed-state on Time Trial Performance
Several studies have reported that carbohydrate (CHO) ingestion can improve performance during exercise of short duration (less than 60 min). However, there is no apparent metabolic explanation for this observation because endogenous CHO stores should not be a limiting factor during short duration exercise. Nonetheless, several groups have attempted to investigate CHO administration during short duration exercise with varying results. When CHO was administered intravenously, no performance effect was observed despite greater plasma glucose availability (5). Therefore, it was suggested that during exercise of short duration, exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous system, possibly mediated by glucose receptors in the mouth. The latter has been investigated using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated results both for (5, 16), and against (1, 19) any improvement in short duration exercise performance when compared with a placebo. The discrepancy in the findings may be due to testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be compromised. However, no study has tested subjects in both the fasted and fed-state using a CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at improving short duration exercise performance when subjects are in the fasted, compared with the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves performance in the fasted-state only compared with a placebo-rinse.
Read the detailed description
It has been well established that carbohydrate (CHO) ingestion during prolonged, moderate- to high-intensity endurance-type exercise can delay the onset of fatigue and enhance exercise performance. Interestingly, several studies have reported that CHO ingestion can also improve performance during more intense exercise of short duration-less than 45-60 min. However, there is no apparent metabolic explanation for this improvement, because endogenous CHO stores should not limit exercise performance during short duration exercise tasks. To examine exogenous and endogenous glucose kinetics during high-intensity cycling exercise, Carter and colleagues tested 6 endurance athletes for 1 h at 75% Wmax while infusing either 20% glucose or 0.9% saline. Despite greater plasma glucose availability in the glucose-infusion trial, total CHO oxidation rates did not differ between treatments. Moreover, no performance benefits were observed after intravenous glucose administration. Consequently, the authors suggested that CHO ingestion during high-intensity exercise of short duration might exert its ergogenic effect by acting through the central nervous system, possibly mediated by glucose receptors in the mouth or gastrointestinal tract.
To test this hypothesis, Carter and colleagues investigated the impact of a carbohydrate mouth-rinse solution on 1-h time trial performance. The use of a mouth-rinse treatment, in which a CHO solution is spat out without swallowing, was chosen to remove any influence of the gut or exogenous CHO oxidation on performance. Participants were reported to cycle faster after a mouth rinse with a 6.4% maltodextrin solution at every 12.5% of the trial completed compared with a placebo rinse. The authors concluded that CHO mouth rinsing improves time trial performance and that the mechanism responsible might be an increase in central drive or motivation mediated by glucose receptors in the mouth. However in the former study, subjects were tested in a fasted state, which is impractical compared to how athletes normally prepare for training and competition.
In follow-up to the former study, we tested the performance effect of a carbohydrate mouth rinse 2 h after subjects ingested a CHO rich meal. From an evolutionary viewpoint, it can be speculated that the potential stimulating effect of glucose in the mouth might be of considerable impact under conditions when liver glycogen stores might be compromised. In agreement with this theory, there was no performance improvement with a CHO mouth rinse during time trial performance 2 h following the ingestion of a CHO -rich meal. However, as there are now studies demonstrating results both for and against any ergogenic effect of a CHO mouth rinse during short duration time trials it remains to be determined whether CHO mouth rinse improves performance during a 1 h time trial in the fasted state only. Therefore, the present study aims to investigate any potential ergogenic effect of a CHO mouth rinse during a 1 h time trial performance in both the fasted and fed state.
- Being tested
- Carbohydrate drink, Placebo mouth rinse
- Keywords
- carbohydrate, performance, cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkDietary supplement
sucrose beverage
Placebo mouth rinseDietary supplement
placebo; non-caloric sweetened beverage for use as a mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| carbohydrate mouth rinse fasted | Experimental | sucrose mouth rinse in the fasted state Receives: Dietary Supplement: Carbohydrate drink |
| carbohydrate mouth rinse fed | Experimental | sucrose mouth rinse fed state Receives: Dietary Supplement: Carbohydrate drink |
| Placebo mouth rinse fed | Placebo comparator | placebo (non-caloric sweetened drink) in the fed state Receives: Dietary Supplement: Placebo mouth rinse |
| Placebo mouth rinse fasted | Placebo comparator | placebo (non-caloric sweetened drink) in the fasted condition Receives: Dietary Supplement: Placebo mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete a set amount of work (time-trial performance)
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Measured: laboratory visit 2
Time to complete a set amount of work (time trial performance)
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Measured: laboratory visit 3
Time to complete a set amount of work (time-trial performance)
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Measured: laboratory visit 4
Time to complete a set amount of work (time-trial performance)
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Measured: laboratory visit 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate Mouth-rinse on Time Trial PerformanceStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, Ph.D., Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527266
- Sponsor's protocol ID
- 11-3-068
- Acronym
- CHO rinse
- Status last verified
- Oct 2012
- First submitted
- 12 Jan 2012
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Sucrose Mouth-rinse in the Fasted and Fed-state on Time Trial Performance
- ClinicalTrials.gov ID
- NCT01527266
- Acronym / sponsor ID
- CHO rinse / 11-3-068
- Keywords
- carbohydrate, performance, cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 6 Feb 2012 (estimated)
- 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.
Several studies have reported that carbohydrate (CHO) ingestion can improve performance during exercise of short duration (less than 60 min). However, there is no apparent metabolic explanation for this observation because endogenous CHO stores should not be a limiting factor during short duration exercise. Nonetheless, several groups have attempted to investigate CHO administration during short duration exercise with varying results. When CHO was administered intravenously, no performance effect was observed despite greater plasma glucose availability (5). Therefore, it was suggested that during exercise of short duration, exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous system, possibly mediated by glucose receptors in the mouth. The latter has been investigated using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated results both for (5, 16), and against (1, 19) any improvement in short duration exercise performance when compared with a placebo. The discrepancy in the findings may be due to testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be compromised. However, no study has tested subjects in both the fasted and fed-state using a CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at improving short duration exercise performance when subjects are in the fasted, compared with the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves performance in the fasted-state only compared with a placebo-rinse.
Detailed description
It has been well established that carbohydrate (CHO) ingestion during prolonged, moderate- to high-intensity endurance-type exercise can delay the onset of fatigue and enhance exercise performance. Interestingly, several studies have reported that CHO ingestion can also improve performance during more intense exercise of short duration-less than 45-60 min. However, there is no apparent metabolic explanation for this improvement, because endogenous CHO stores should not limit exercise performance during short duration exercise tasks. To examine exogenous and endogenous glucose kinetics during high-intensity cycling exercise, Carter and colleagues tested 6 endurance athletes for 1 h at 75% Wmax while infusing either 20% glucose or 0.9% saline. Despite greater plasma glucose availability in the glucose-infusion trial, total CHO oxidation rates did not differ between treatments. Moreover, no performance benefits were observed after intravenous glucose administration. Consequently, the authors suggested that CHO ingestion during high-intensity exercise of short duration might exert its ergogenic effect by acting through the central nervous system, possibly mediated by glucose receptors in the mouth or gastrointestinal tract.
To test this hypothesis, Carter and colleagues investigated the impact of a carbohydrate mouth-rinse solution on 1-h time trial performance. The use of a mouth-rinse treatment, in which a CHO solution is spat out without swallowing, was chosen to remove any influence of the gut or exogenous CHO oxidation on performance. Participants were reported to cycle faster after a mouth rinse with a 6.4% maltodextrin solution at every 12.5% of the trial completed compared with a placebo rinse. The authors concluded that CHO mouth rinsing improves time trial performance and that the mechanism responsible might be an increase in central drive or motivation mediated by glucose receptors in the mouth. However in the former study, subjects were tested in a fasted state, which is impractical compared to how athletes normally prepare for training and competition.
In follow-up to the former study, we tested the performance effect of a carbohydrate mouth rinse 2 h after subjects ingested a CHO rich meal. From an evolutionary viewpoint, it can be speculated that the potential stimulating effect of glucose in the mouth might be of considerable impact under conditions when liver glycogen stores might be compromised. In agreement with this theory, there was no performance improvement with a CHO mouth rinse during time trial performance 2 h following the ingestion of a CHO -rich meal. However, as there are now studies demonstrating results both for and against any ergogenic effect of a CHO mouth rinse during short duration time trials it remains to be determined whether CHO mouth rinse improves performance during a 1 h time trial in the fasted state only. Therefore, the present study aims to investigate any potential ergogenic effect of a CHO mouth rinse during a 1 h time trial performance in both the fasted and fed state.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| carbohydrate mouth rinse fasted | Experimental | Dietary Supplement: Carbohydrate drinksucrose mouth rinse in the fasted state |
| carbohydrate mouth rinse fed | Experimental | Dietary Supplement: Carbohydrate drinksucrose mouth rinse fed state |
| Placebo mouth rinse fed | Placebo comparator | Dietary Supplement: Placebo mouth rinseplacebo (non-caloric sweetened drink) in the fed state |
| Placebo mouth rinse fasted | Placebo comparator | Dietary Supplement: Placebo mouth rinseplacebo (non-caloric sweetened drink) in the fasted condition |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy
- Male
- 18 - 35 years of age
- Endurance cycling trained (≥ 3 sessions of endurance exercise per week)
- VO2 max ≥ 50 ml/kg/min
Key exclusion criteria (2 listed)
- Use of medication
- Smoking
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 drinksucrose beverage | Dietary supplement | carbohydrate mouth rinse fasted, carbohydrate mouth rinse fed |
| Placebo mouth rinseplacebo; non-caloric sweetened beverage for use as a mouth rinse | Dietary supplement | Placebo mouth rinse fasted, Placebo mouth rinse fed |
Primary outcome
Time to complete a set amount of work (time-trial performance)
Time frame: laboratory visit 2
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Time to complete a set amount of work (time trial performance)
Time frame: laboratory visit 3
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Time to complete a set amount of work (time-trial performance)
Time frame: laboratory visit 4
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Time to complete a set amount of work (time-trial performance)
Time frame: laboratory visit 5
Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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.
Luc van Loon, Ph.D. study director
Maastricht University
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 drink in people with Carbohydrate Mouth-rinse on Time Trial Performance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Oct 2012. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Cermak, Ph.D. (31433881393, naomi.cermak@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete a set amount of work (time-trial performance) (time frame: laboratory visit 2). The study lists 4 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 17 Oct 2012.