ExerciseNCT03749785
Carbohydrate Feeding Frequency, Muscle Glycogen and Exercise Capacity in Runners
A study testing Regular carbohydrate feeding and Single carbohydrate bolus in people with Exercise, run by University of Bath at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Regular carbohydrate feeding and Single carbohydrate bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2018to 16 Apr 2019
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as a trained runner
- Regularly participate in running activity (>2 times a week)
- Participated in running based training for a minimum of 2 years
- Be willing to undertake exercise sessions until volitional exhaustion
- Be willing to have the necessary samples taken during the testing protocols
- Not a habitual smoker
- Have the capacity and willingness to provide informed consent (oral and written)
- Successful completion of the physical activity readiness questionnaire (PAR-Q)
Who cannot join
- Female
- <18 or >50 years old
- Not regularly participating in running activity (<3 times a week)
- Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
- Habitual/previously habitual smoker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: The Effect of Carbohydrate Feeding Frequency on Muscle Glycogen and Exercise Capacity in Runners
The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running
- Conditions
- Exercise
- Being tested
- Regular carbohydrate feeding, Single carbohydrate bolus
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular carbohydrate feedingOther
60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution
Single carbohydrate bolusOther
60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution
| Study group | Role | What they receive |
|---|---|---|
| Regular carbohydrate feeding | Active comparator | Ingestion of 75 g sucrose, given in regular doses for the first 75 minutes of exercise during a time to exhaustion run Receives: Other: Regular carbohydrate feeding |
| Single carbohydrate bolus | Active comparator | Ingestion of 75 g sucrose, given in a single bolus after 75 minutes of exercise, during a time to exhaustion run Receives: Other: Single carbohydrate bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glycogen concentrations
Muscle glycogen concentration at rest, after 75 minutes of treadmill running and at volitional exhaustion. Measured using the bergstrom needle technique for obtaining muscle biopsy samples
Measured: Estimated to be between 90 and 145 minutes
Exercise capacity
Time to exhaustion at the pre-determined speed to elicit exhaustion after ~90 minutes when ingesting water only
Measured: Estimated to be between 90 and 145 minutes
Secondary outcomes (9)
Ratings of perceived exertion
Subjective ratings of perceived exertion, during treadmill running. Measured using a borg scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion.
Measured: Estimated to be between 90 and 145 minutes
Ratings of stomach discomfort
Subjective ratings of stomach discomfort during treadmill running. Measured using a modified borg scale of 6 to 20, where 6 = no discomfort and 20 = maximal discomfort
Measured: Estimated to be between 90 and 145 minutes
Carbohydrate oxidation
Total carbohydrate oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.
Measured: Estimated to be between 90 and 145 minutes
Fat oxidation
Total fat oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.
Measured: Estimated to be between 90 and 145 minutes
Plasma glucose concentrations
Plasma lactate concentrations during of treadmill running. Measured using colourimetric assay and reported in mmol/L
Measured: Estimated to be between 90 and 145 minutes
Plasma lactate concentrations
Plasma lactate concentrations during treadmill running. Measured using colourimetric assay and reported in mmol/L.
Measured: Estimated to be between 90 and 145 minutes
Heart rate
Heart rate during treadmill running measured by telemetry and reported in beats per minute
Measured: Estimated to be between 90 and 145 minutes
Rate of oxygen consumption
Rate of oxygen consumption during treadmill running. Measured using indirect calorimetry and reported in litres per minute
Measured: Estimated to be between 90 and 145 minutes
Rate of carbon dioxide production
Rate of carbon dioxide production during treadmill running. Measured using indirect calorimetry and reported in litres per minute.
Measured: Estimated to be between 90 and 145 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start14 Oct 2018
- Primary completion20 Mar 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Betts, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749785
- Sponsor's protocol ID
- 18/SW/0177
- Status last verified
- Mar 2019
- First submitted
- 19 Nov 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbohydrate Feeding Frequency on Muscle Glycogen and Exercise Capacity in Runners
- ClinicalTrials.gov ID
- NCT03749785
- Acronym / sponsor ID
- 18/SW/0177
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 14 Oct 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 21 Nov 2018 (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.
The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular carbohydrate feeding | Active comparator | Other: Regular carbohydrate feedingIngestion of 75 g sucrose, given in regular doses for the first 75 minutes of exercise during a time to exhaustion run |
| Single carbohydrate bolus | Active comparator | Other: Single carbohydrate bolusIngestion of 75 g sucrose, given in a single bolus after 75 minutes of exercise, during a time to exhaustion run |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Self-identify as a trained runner
- Regularly participate in running activity (>2 times a week)
- Participated in running based training for a minimum of 2 years
- Be willing to undertake exercise sessions until volitional exhaustion
- Be willing to have the necessary samples taken during the testing protocols
Key exclusion criteria (5 listed)
- Female
- <18 or >50 years old
- Not regularly participating in running activity (<3 times a week)
- Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
- Habitual/previously habitual smoker
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 |
|---|---|---|
| Regular carbohydrate feeding60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution | Other | Regular carbohydrate feeding |
| Single carbohydrate bolus60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution | Other | Single carbohydrate bolus |
Primary outcome
Muscle glycogen concentrations
Time frame: Estimated to be between 90 and 145 minutes
Muscle glycogen concentration at rest, after 75 minutes of treadmill running and at volitional exhaustion. Measured using the bergstrom needle technique for obtaining muscle biopsy samples
Exercise capacity
Time frame: Estimated to be between 90 and 145 minutes
Time to exhaustion at the pre-determined speed to elicit exhaustion after ~90 minutes when ingesting water only
9 secondary outcomes
Ratings of perceived exertion
Time frame: Estimated to be between 90 and 145 minutes
Ratings of stomach discomfort
Time frame: Estimated to be between 90 and 145 minutes
Carbohydrate oxidation
Time frame: Estimated to be between 90 and 145 minutes
Fat oxidation
Time frame: Estimated to be between 90 and 145 minutes
Plasma glucose concentrations
Time frame: Estimated to be between 90 and 145 minutes
Plasma lactate concentrations
Time frame: Estimated to be between 90 and 145 minutes
Heart rate
Time frame: Estimated to be between 90 and 145 minutes
Rate of oxygen consumption
Time frame: Estimated to be between 90 and 145 minutes
Rate of carbon dioxide production
Time frame: Estimated to be between 90 and 145 minutes
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 1 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular carbohydrate feeding and Single carbohydrate bolus in people with Exercise, run by University of Bath at 1 site in United Kingdom.
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 8 inclusion and 5 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 1 Nov 2019. 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 Kingdom. 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. 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?
Muscle glycogen concentrations (time frame: Estimated to be between 90 and 145 minutes). The study lists 2 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 1 Nov 2019.