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Dietary SupplementationsNCT04859491

Effect of Carbohydrate-protein Co-ingestion on Short-term Recovery

A study testing Carbohydrate and Carbohydrate-Protein in people with Dietary Supplementations, run by Erica Goldstein at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 59 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dietary Supplementations
What is being tested?
Carbohydrate and Carbohydrate-Protein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
22 Jul 2021to 5 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 59 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Central Florida

    Orlando, Florida, 32816

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Carbohydrate, Carbohydrate-Protein, Placebo
Keywords
glycogen, glucose, aerobic exercise, time to exhaustion, supplementation, protein, endurance, recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarbohydrateDietary supplement

    Also called CHO

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

  • Carbohydrate-ProteinDietary supplement

    Also called CHO-P

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

  • PlaceboDietary supplement

    Also called PLA

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

Study groups in NCT04859491
Study groupRoleWhat they receive
CarbohydrateActive comparatorCarbohydrate in the amount of 1.2 g/kg of body weight (bw). Gatorade®, Chicago, IL, USA.
Receives: Dietary Supplement: Carbohydrate
Carbohydrate-ProteinActive comparatorCarbohydrate 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).
Receives: Dietary Supplement: Carbohydrate-Protein
PlaceboPlacebo comparatorFlavored water (G Zero, Gatorade®, Chicago, IL, USA).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Exhaustion (TTE)

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

    Measured: Visit #3 (Day 7)

Secondary outcomes (2)

  1. Heart Rate Variability (HRV)

    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).

    Measured: Visit #3 (Day 7)

  2. Sweat Rate (SR)

    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.

    Measured: Visit #3 (Day 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start22 Jul 2021
  3. Primary completion5 Dec 2021
  4. Study completion5 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04859491
Sponsor's protocol ID
MCAs and Short-Term Recovery
Status last verified
May 2022
First submitted
30 Mar 2021
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31188694

  • 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.

    PubMed 27097042

  • 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.

    PubMed 16775553

Questions about this trial

What is this clinical trial studying?

A study testing Carbohydrate and Carbohydrate-Protein in people with Dietary Supplementations, run by Erica Goldstein at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Exhaustion (TTE) (time frame: Visit #3 (Day 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04859491, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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