NCT04859491

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

March 30, 2021

Last Update Submit

May 16, 2022

Conditions

Keywords

glycogenglucoseaerobic exercisetime to exhaustionsupplementationproteinendurancerecovery

Outcome Measures

Primary Outcomes (1)

  • Time to Exhaustion (TTE)

    Participants cycle for as long as possible at 90% of peak power output (watts)

    Visit #3 (Day 7)

Secondary Outcomes (2)

  • Heart Rate Variability (HRV)

    Visit #3 (Day 7)

  • Sweat Rate (SR)

    Visit #3 (Day 7)

Study Arms (3)

Carbohydrate

ACTIVE COMPARATOR

Carbohydrate in the amount of 1.2 g/kg of body weight (bw). Gatorade®, Chicago, IL, USA.

Dietary Supplement: Carbohydrate

Carbohydrate-Protein

ACTIVE COMPARATOR

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).

Dietary Supplement: Carbohydrate-Protein

Placebo

PLACEBO COMPARATOR

Flavored water (G Zero, Gatorade®, Chicago, IL, USA).

Dietary Supplement: Placebo

Interventions

CarbohydrateDIETARY_SUPPLEMENT

Participants have a one in three chance of consuming a carbohydrate beverage between two bouts of high-intensity exercise.

Also known as: CHO
Carbohydrate
Carbohydrate-ProteinDIETARY_SUPPLEMENT

Participants have a one in three chance of consuming a carbohydrate-protein beverage between two bouts of high-intensity exercise.

Also known as: CHO-P
Carbohydrate-Protein
PlaceboDIETARY_SUPPLEMENT

Participants have a one in three chance of consuming a placebo beverage between two bouts of high-intensity exercise.

Also known as: PLA
Placebo

Eligibility Criteria

Age35 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

Related Publications (3)

  • 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. doi: 10.1249/01.mss.0000222826.49358.f3.

MeSH Terms

Interventions

Carbohydrates

Study Officials

  • Jeffrey Stout, PhD

    University of Central Florida

    STUDY CHAIR
  • Erica Goldstein, MS

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The primary investigator will not be blinded to the treatment groups. However, both the research assistants responsible for administering the experimental protocol (aerobic interval and time to exhaustion testing) and the participants will be.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of three groups: isocaloric carbohydrate (1.2 g/kg of body weight), carbohydrate-protein (0.8 g/kg body weight carbohydrate + 0.4 g/kg body weight protein), or placebo (flavored water). All three beverages will have a similar appearance and taste and participants will be blinded to the contents. All beverages will contain the same volume of fluid (1 liter).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate Research Associate

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 26, 2021

Study Start

July 22, 2021

Primary Completion

December 5, 2021

Study Completion

December 5, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations