Dietary CarbohydrateCOWNCT04145050
Carbohydrate Oxidation in Elite Wheelchair Racers During Marathon Simulation
A study testing Carbohydrate dosing in people with Dietary Carbohydrate and Para-Athletes, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
To examine the effect of varying amounts of carbohydrate ingestion on performance, gastrointestinal experiences, and other physiological markers in elite wheelchair racers during a simulated marathon. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Carbohydrate, Para-Athletes
- What is being tested?
- Carbohydrate dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Jul 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- < 2-hour best marathon time
- 6 months prior training history
Who cannot join
- - Chronic Smoking or tobacco use
- Active cardiovascular disease
- Diabetes Mellitus or other metabolic disorders
- Liver kidney, or urinary disease
- Musculoskeletal/Orthopedic disorders (e.g., osteoarthritis, rheumatoid arthritis, tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)
- Neuromuscular disorders
Show all 15Show fewer
- hypertension
- Diagnosed GI tract diseases
- Heart Disease
- Neurological disease
- Epilepsy
- Respiratory disease
- Pregnancy
- Contraindications for exercise
- <6 months of prior training history
Trial locations and contacts
1 site in 1 country.
Amadeo F Salvador, M.S. contact
United States1 site
Disability Rehababilitation and Education Services
Champaign, Illinois, 61820
Maureen Gilbert, M.S., 217-333-4607, mlgilbrt@illinois.edu
About this study
To examine the effect of varying amounts of carbohydrate ingestion on performance, gastrointestinal experiences, and other physiological markers in elite wheelchair racers during a simulated marathon.
Read the detailed description
The metabolic demands created by endurance activities, which include muscle and liver glycogen depletion as well as losses in body fluids and electrolytes, are significant limitations to the performance potential of the athlete. For this reason, a well-supported recommendation exists for such athletes to consume a carbohydrate (CHO) formula, in particular, one containing electrolytes during their activity. Furthermore, the current CHO recommendations to support prolonged activity have been developed specifically for able-bodied athletes, thus are potentially inappropriate for para athletes.
Metabolic and physiological functions are altered in individuals with physical disabilities, so it is unknown how transferable these recommendations are to para athletes. As such, it is important to understand this population's unique carbohydrate requirements for performance optimization.
Recently, our group showed stable elevated circulating glucose concentrations by utilizing two different sources of CHO dosed at 60 g/h when compared to water. Significantly improved performance was observed with both CHO conditions. These findings, combined with studies showing decreased net muscle glycogen degradation during intravenous glucose infusion (3.5 g/min), show the importance of plasma glucose concentration for sustained performance. Therefore, the purpose of this study is to investigate the SCI-specific responses to exogenous CHO during a full marathon simulation (MS).
Twelve highly trained men and women (20-50 yrs old) will be recruited to the study. The inclusion criteria are: 1.) Best marathon time lower than 2h 2.) and ≥6 months of prior training history. After initial screenings, participants will perform three marathon (MS) trials. In cross-over trials, each subject will participate in a MS trial consisting of a challenge (90% of subject's best marathon time) followed by a time trial (TT) representing the last 10% of the marathon time. During each MS trial, participants will be randomly assigned to receive either water, 30g, or 60g of carbohydrate (CHO) every 15 minutes in the form of a sports nutrition beverage. Repeated blood and breath sampling will occur throughout the MS. These samples will be used to determine glucose concentration, lactate concentration, as well as CHO and fat oxidation. Heart rate, core temperature, blood pressure, ratings of perceived exertion and GI symptoms will also be assessed throughout the MS and after the time trial.
Completion of this research study will help to identify more appropriate CHO recommendations for para athletes to support prolonged endurance exercise. This will aid in the understanding of the unique physiological and metabolic needs of para athletes as compared to their able-bodied counterparts, thus enhancing inclusivity within sports nutrition literature.
- Conditions
- Dietary Carbohydrate, Para-Athletes
- Being tested
- Carbohydrate dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate dosingOther
The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Dose: 0 grams carbohydrate | Experimental | Participants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. Receives: Other: Carbohydrate dosing |
| Carbohydrate Dose: 30 grams carbohydrate | Experimental | Participants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. Receives: Other: Carbohydrate dosing |
| Carbohydrate Dose: 60 grams carbohydrate | Experimental | Participants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. Receives: Other: Carbohydrate dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Performance will be measured by time required to complete a 2.6 mile time-trial immediately following marathon simulation
Measured: 10-15 minutes
Secondary outcomes (5)
Ratings of gastrointestinal (GI) experiences
Using a visual analog scale (Visual Analog Symptom Scale), participants will record GI symptoms (from 0-100 whereby higher numbers indicate worse experiences) at various time points throughout experimental trial
Measured: Throughout experimental protocol for 1.5 - 2 hours
Blood Glucose Concentration
Blood glucose concentration will be measured at various time points throughout experimental trial
Measured: Throughout experimental protocol for 1.5 - 2 hours
Blood Lactate Concentration
Blood lactate concentration will be measured at various time points throughout experimental trials
Measured: Throughout experimental protocol for 1.5 - 2 hours
Core Temperature
Core temperature will be measured at various time points throughout experimental trials via ingestible thermometer sensors
Measured: Throughout experimental protocol for 1.5 - 2 hours
Rated Perceived Exertion (RPE)
RPE, or how hard an athlete feels they are working, will be recorded at various time points throughout the experimental trial
Measured: Throughout experimental protocol for 1.5 - 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary CarbohydrateStudies 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
- Model description
- Randomized, Cross-Over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Burd, University of Illinois at Urbana-Champaign
- Investigators
- Nicholas A Burd, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145050
- Sponsor's protocol ID
- 20020
- Acronym
- COW
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be coded and de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Oxidation in Elite Wheelchair Racers During Marathon Simulation
- ClinicalTrials.gov ID
- NCT04145050
- Acronym / sponsor ID
- COW / 20020
- Conditions
- Dietary Carbohydrate, Para-Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 30 Oct 2019 (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.
To examine the effect of varying amounts of carbohydrate ingestion on performance, gastrointestinal experiences, and other physiological markers in elite wheelchair racers during a simulated marathon.
Detailed description
The metabolic demands created by endurance activities, which include muscle and liver glycogen depletion as well as losses in body fluids and electrolytes, are significant limitations to the performance potential of the athlete. For this reason, a well-supported recommendation exists for such athletes to consume a carbohydrate (CHO) formula, in particular, one containing electrolytes during their activity. Furthermore, the current CHO recommendations to support prolonged activity have been developed specifically for able-bodied athletes, thus are potentially inappropriate for para athletes.
Metabolic and physiological functions are altered in individuals with physical disabilities, so it is unknown how transferable these recommendations are to para athletes. As such, it is important to understand this population's unique carbohydrate requirements for performance optimization.
Recently, our group showed stable elevated circulating glucose concentrations by utilizing two different sources of CHO dosed at 60 g/h when compared to water. Significantly improved performance was observed with both CHO conditions. These findings, combined with studies showing decreased net muscle glycogen degradation during intravenous glucose infusion (3.5 g/min), show the importance of plasma glucose concentration for sustained performance. Therefore, the purpose of this study is to investigate the SCI-specific responses to exogenous CHO during a full marathon simulation (MS).
Twelve highly trained men and women (20-50 yrs old) will be recruited to the study. The inclusion criteria are: 1.) Best marathon time lower than 2h 2.) and ≥6 months of prior training history. After initial screenings, participants will perform three marathon (MS) trials. In cross-over trials, each subject will participate in a MS trial consisting of a challenge (90% of subject's best marathon time) followed by a time trial (TT) representing the last 10% of the marathon time. During each MS trial, participants will be randomly assigned to receive either water, 30g, or 60g of carbohydrate (CHO) every 15 minutes in the form of a sports nutrition beverage. Repeated blood and breath sampling will occur throughout the MS. These samples will be used to determine glucose concentration, lactate concentration, as well as CHO and fat oxidation. Heart rate, core temperature, blood pressure, ratings of perceived exertion and GI symptoms will also be assessed throughout the MS and after the time trial.
Completion of this research study will help to identify more appropriate CHO recommendations for para athletes to support prolonged endurance exercise. This will aid in the understanding of the unique physiological and metabolic needs of para athletes as compared to their able-bodied counterparts, thus enhancing inclusivity within sports nutrition literature.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Cross-Over
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Dose: 0 grams carbohydrate | Experimental | Other: Carbohydrate dosingParticipants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. |
| Carbohydrate Dose: 30 grams carbohydrate | Experimental | Other: Carbohydrate dosingParticipants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. |
| Carbohydrate Dose: 60 grams carbohydrate | Experimental | Other: Carbohydrate dosingParticipants will be randomly selected, in a cross-over fashion, to ingest 0 grams/hour, 30 grams/ hour, or 60 grams/ hour of carbohydrate beverage throughout each experimental trial. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- < 2-hour best marathon time
Key exclusion criteria (15 listed)
- - Chronic Smoking or tobacco use
- Active cardiovascular disease
- Diabetes Mellitus or other metabolic disorders
- Liver kidney, or urinary disease
- Musculoskeletal/Orthopedic disorders (e.g., osteoarthritis, rheumatoid arthritis, tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)
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 dosingThe purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers. | Other | Carbohydrate Dose: 0 grams carbohydrate, Carbohydrate Dose: 30 grams carbohydrate, Carbohydrate Dose: 60 grams carbohydrate |
Primary outcome
Performance
Time frame: 10-15 minutes
Performance will be measured by time required to complete a 2.6 mile time-trial immediately following marathon simulation
5 secondary outcomes
Ratings of gastrointestinal (GI) experiences
Time frame: Throughout experimental protocol for 1.5 - 2 hours
Blood Glucose Concentration
Time frame: Throughout experimental protocol for 1.5 - 2 hours
Blood Lactate Concentration
Time frame: Throughout experimental protocol for 1.5 - 2 hours
Core Temperature
Time frame: Throughout experimental protocol for 1.5 - 2 hours
Rated Perceived Exertion (RPE)
Time frame: Throughout experimental protocol for 1.5 - 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. Data will be coded and de-identified.
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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.
Amadeo F Salvador, M.S. contact
Nicholas A Burd, PhD principal investigator
University of Illinois at Urbana-Champaign
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 dosing in people with Dietary Carbohydrate and Para-Athletes, run by University of Illinois at Urbana-Champaign 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 2 inclusion and 15 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 28 Apr 2021. 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. 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 Susannah E Scaroni, B.S. (509-280-3743, scaroni1@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 10-15 minutes). 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 28 Apr 2021.