NCT04145050

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

October 28, 2019

Last Update Submit

April 26, 2021

Conditions

Dietary CarbohydratePara-Athletes

Outcome Measures

Primary Outcomes (1)

  • Performance

    Performance will be measured by time required to complete a 2.6 mile time-trial immediately following marathon simulation

    10-15 minutes

Secondary Outcomes (5)

  • Ratings of gastrointestinal (GI) experiences

    Throughout experimental protocol for 1.5 - 2 hours

  • Blood Glucose Concentration

    Throughout experimental protocol for 1.5 - 2 hours

  • Blood Lactate Concentration

    Throughout experimental protocol for 1.5 - 2 hours

  • Core Temperature

    Throughout experimental protocol for 1.5 - 2 hours

  • Rated Perceived Exertion (RPE)

    Throughout experimental protocol for 1.5 - 2 hours

Study Arms (3)

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.

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.

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.

Other: Carbohydrate dosing

Interventions

Carbohydrate dosingOTHER

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

Carbohydrate Dose: 0 grams carbohydrateCarbohydrate Dose: 30 grams carbohydrateCarbohydrate Dose: 60 grams carbohydrate

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \< 2-hour best marathon time
  • months prior training history

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Disability Rehababilitation and Education Services

Champaign, Illinois, 61820, United States

Location

Study Officials

  • Nicholas A Burd, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susannah E Scaroni, B.S.

CONTACT

509-280-3743scaroni1@illinois.edu

Amadeo F Salvador, M.S.

CONTACT

amadeos2@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants as well as researchers will not be informed of trial intervention
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, Cross-Over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Data will be coded and de-identified.

Locations

US(1)