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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04145050
Other study ID # 20020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date July 1, 2024

Study information

Verified date April 2021
Source University of Illinois at Urbana-Champaign
Contact Susannah E Scaroni, B.S.
Phone 509-280-3743
Email scaroni1@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date July 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Carbohydrate dosing
The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.

Locations

Country Name City State
United States Disability Rehababilitation and Education Services Champaign Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance Performance will be measured by time required to complete a 2.6 mile time-trial immediately following marathon simulation 10-15 minutes
Secondary 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 Throughout experimental protocol for 1.5 - 2 hours
Secondary Blood Glucose Concentration Blood glucose concentration will be measured at various time points throughout experimental trial Throughout experimental protocol for 1.5 - 2 hours
Secondary Blood Lactate Concentration Blood lactate concentration will be measured at various time points throughout experimental trials Throughout experimental protocol for 1.5 - 2 hours
Secondary Core Temperature Core temperature will be measured at various time points throughout experimental trials via ingestible thermometer sensors Throughout experimental protocol for 1.5 - 2 hours
Secondary 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 Throughout experimental protocol for 1.5 - 2 hours