- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145050
Carbohydrate Oxidation in Elite Wheelchair Racers During Marathon Simulation (COW)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susannah E Scaroni, B.S.
- Phone Number: 509-280-3743
- Email: scaroni1@illinois.edu
Study Contact Backup
- Name: Amadeo F Salvador, M.S.
- Email: amadeos2@illinois.edu
Study Locations
-
-
Illinois
-
Champaign, Illinois, United States, 61820
- Disability Rehababilitation and Education Services
-
Contact:
- Maureen Gilbert, M.S.
- Phone Number: 217-333-4607
- Email: mlgilbrt@illinois.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
< 2-hour best marathon time
- 6 months prior training history
Exclusion Criteria:
- - 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
- hypertension
- Diagnosed GI tract diseases
- Heart Disease
- Neurological disease
- Epilepsy
- Respiratory disease
- Pregnancy
- Contraindications for exercise
- <6 months of prior training history
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbohydrate Dose: 0 grams carbohydrate
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.
|
The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.
|
|
Experimental: Carbohydrate Dose: 30 grams carbohydrate
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.
|
The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.
|
|
Experimental: Carbohydrate Dose: 60 grams carbohydrate
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.
|
The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
10-15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratings of gastrointestinal (GI) experiences
Time Frame: Throughout experimental protocol for 1.5 - 2 hours
|
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
|
Throughout experimental protocol for 1.5 - 2 hours
|
|
Blood Glucose Concentration
Time Frame: Throughout experimental protocol for 1.5 - 2 hours
|
Blood glucose concentration will be measured at various time points throughout experimental trial
|
Throughout experimental protocol for 1.5 - 2 hours
|
|
Blood Lactate Concentration
Time Frame: Throughout experimental protocol for 1.5 - 2 hours
|
Blood lactate concentration will be measured at various time points throughout experimental trials
|
Throughout experimental protocol for 1.5 - 2 hours
|
|
Core Temperature
Time Frame: Throughout experimental protocol for 1.5 - 2 hours
|
Core temperature will be measured at various time points throughout experimental trials via ingestible thermometer sensors
|
Throughout experimental protocol for 1.5 - 2 hours
|
|
Rated Perceived Exertion (RPE)
Time Frame: Throughout experimental protocol for 1.5 - 2 hours
|
RPE, or how hard an athlete feels they are working, will be recorded at various time points throughout the experimental trial
|
Throughout experimental protocol for 1.5 - 2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicholas A Burd, PhD, University of Illinois at Urbana-Champaign
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Carbohydrate
-
Technical University of MunichMetaflow Ltd.CompletedDietary Carbohydrate Restriction, Energy DeficitGermany
-
University of Nebraska LincolnNational Cattlemen's Beef Association, a contractor to the Beef CheckoffRecruitingCognitive Ability, General | Dietary Intervention | Dietary Proteins | Dietary AssessmentUnited States
-
The University of Tennessee, KnoxvilleCompletedDietary Assessment | 24-hour Dietary Recall | Dietary Restraint | Social DesirabilityUnited States
-
University of ReadingUnknownDietary Habits | Dietary ModificationUnited Kingdom
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
Brown UniversityNational Cancer Institute (NCI); University of ConnecticutCompletedDietary Habits | Dietary Modification
-
Augusta UniversityTerminatedDietary Fructose IntoleranceUnited States
-
Wageningen UniversityNetherlands: Ministry of Health, Welfare and Sports; Kellogg Company; Sensus; B... and other collaboratorsCompletedDietary Habits | Microbiota | Dietary Fiber | Personalized AdviceNetherlands
-
University of British ColumbiaCompletedDietary Supplement: Ketone Supplement | Dietary Supplement: PlaceboCanada
-
University of Kansas Medical CenterCompletedDietary Habits | Knowledge, Attitudes, Practice | Dietary Modification | LiteracyUnited States
Clinical Trials on Carbohydrate dosing
-
Murdoch Childrens Research InstituteUniversity of Otago; Sydney Children's Hospitals Network; Royal Children's Hospital and other collaboratorsCompletedSepsis | Bacteremia | InfectionAustralia
-
Wake Forest University Health SciencesTerminatedSepsis | Obesity | Septic ShockUnited States
-
Spectrum Pharmaceuticals, IncTerminated
-
Northern Jiangsu People's HospitalNot yet recruiting
-
AstraZenecaCompletedPrimary Aldosteronism | HyperaldosteronismUnited States
-
University of Child Health Sciences and Children...CompletedIron Deficiency Anemia | Iron Deficiency Anemia TreatmentPakistan
-
Rush University Medical CenterWithdrawnChronic Low-back Pain | Peripheral Neuropathy | CRPS
-
AstraZenecaCompletedHealthy VolunteersUnited States
-
NorgineCompletedColorectal Cancer | Colorectal Carcinoma | Colon CleansingUnited Kingdom, Spain, Belgium, France, Germany, Italy, Poland
-
University of Illinois at Urbana-ChampaignAbbott NutritionCompletedDietary Modification | Cognitive Ability, GeneralUnited States