- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859491
Effect of Carbohydrate-protein Co-ingestion on Short-term Recovery
May 16, 2022 updated by: Erica Goldstein
Effects of Post-Exercise Recovery Drink Composition on Subsequent Performance in Masters Class Athletes
The purpose of this study is to determine whether the consumption of a carbohydrate, carbohydrate plus protein, or placebo sports drink during a 2-hour recovery period effectively moderates performance decrements during a subsequent bout of high-intensity exercise.
This information will benefit any endurance-trained masters class athlete who may need to compete or train multiple times a day.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To test the hypothesis, this study will utilize a randomized, double-blind, placebo-controlled between-subject design to examine the effects of carbohydrate (CHO) and carbohydrate-protein (CHO-P) supplementation on short-term recovery following aerobic interval exercise (INT) and time to exhaustion (TTE) testing in maters class athletes.
After completing the informed consent and screening process (Visit #1), each participant will be assessed for their anthropometric measures as well as body composition and will complete a graded exercise test to volitional exhaustion on a cycle ergometer to determine VO2peak.
Forty-eight to 72 hours after Visit #1, or VO2peak testing, participants will return to the lab for familiarization with the INT exercise protocol and TTE test (Visit #2).
Within forty-eight to 72 hours after familiarization (Visit #2), participants will return to the lab for Visit #3 to complete INT exercise and TTE, a 2-hour passive recovery period including the consumption of one of three treatments (CHO, CHO-P, PLA), followed by repeated INT exercise and TTE, heart rate variability and sweat rate determination.
Participants will also complete the Nutritional Recovery Practices, Knowledge, and Beliefs of Australian Triathletes survey during the 2-hour recovery period.
Participants will be asked to complete the ASA24®, an automated self-administered 24-hour dietary assessment tool during the 5-9-day period between familiarization (Visit #2) and the experimental protocol (Visit #3).
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men between the ages of 35 and 59 years
- Free of any physical limitations as determined by the Exercise Preparticipation Health Screening Questionnaire for Exercise Professionals (PHSQEP), and a Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Regularly engaged in endurance exercise (running, cycling, swimming) for a minimum of three years, a weekly training volume of 5-10 hours, and a maximal oxygen uptake of 45.00 ml·kg-1·min-1 or higher as determined by completion of VO2peak assessment (Visit #1).
Exclusion Criteria:
- Recent musculoskeletal injuries or surgeries
- Any chronic illness that requires continuous medical care
- Current incarceration, cognitive impairment or inability to provide consent
- Present or past use of performance-enhancing drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Carbohydrate
Carbohydrate in the amount of 1.2 g/kg of body weight (bw).
Gatorade®, Chicago, IL, USA.
|
Participants have a one in three chance of consuming a carbohydrate beverage between two bouts of high-intensity exercise.
Other Names:
|
|
Active Comparator: Carbohydrate-Protein
Carbohydrate in the amount of 0.8 g/kg bw (Gatorade®, Chicago, IL, USA) plus protein in the amount of 0.4 g/kg bw (biPro Elite, Agropur Inc., Appleton, WI, USA).
|
Participants have a one in three chance of consuming a carbohydrate-protein beverage between two bouts of high-intensity exercise.
Other Names:
|
|
Placebo Comparator: Placebo
Flavored water (G Zero, Gatorade®, Chicago, IL, USA).
|
Participants have a one in three chance of consuming a placebo beverage between two bouts of high-intensity exercise.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Exhaustion (TTE)
Time Frame: Visit #3 (Day 7)
|
Participants cycle for as long as possible at 90% of peak power output (watts)
|
Visit #3 (Day 7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability (HRV)
Time Frame: Visit #3 (Day 7)
|
R-R intervals recorded via a heart rate monitor and Elite HRV will be downloaded and analyzed using a laptop with commercially available HRV analysis software.
Root mean square of the successive differences of R-R intervals (RMSSD) values will be recorded during the 90% TTE and then post-exercise every 5 min (end of TTE, 5min, 10min, 15min, 20min, 25min, 30min).
|
Visit #3 (Day 7)
|
|
Sweat Rate (SR)
Time Frame: Visit #3 (Day 7)
|
Sweat rate will be determined based on the difference between pre-and post-weight changes for each bout of exercise, the amount of fluid consumed during the recovery period, and total exercise time in minutes.
|
Visit #3 (Day 7)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jeffrey Stout, PhD, University of Central Florida
- Principal Investigator: Erica Goldstein, MS, University of Central Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McCarthy DG, Spriet LL. Performance Effects of Carbohydrate Ingestion Between Bouts of Intense Aerobic Interval Exercise. Int J Sports Physiol Perform. 2020 Feb 1;15(2):262-267. doi: 10.1123/ijspp.2019-0239. Epub 2019 Jun 12.
- Alghannam AF, Jedrzejewski D, Bilzon J, Thompson D, Tsintzas K, Betts JA. Influence of Post-Exercise Carbohydrate-Protein Ingestion on Muscle Glycogen Metabolism in Recovery and Subsequent Running Exercise. Int J Sport Nutr Exerc Metab. 2016 Dec;26(6):572-580. doi: 10.1123/ijsnem.2016-0021. Epub 2016 Aug 24.
- Berardi JM, Price TB, Noreen EE, Lemon PW. Postexercise muscle glycogen recovery enhanced with a carbohydrate-protein supplement. Med Sci Sports Exerc. 2006 Jun;38(6):1106-13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2021
Primary Completion (Actual)
December 5, 2021
Study Completion (Actual)
December 5, 2021
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 21, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MCAs and Short-Term Recovery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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