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FatigueNCT04114045

Effects of Post-exercise Protein Supplementation in Young Athletes

A study testing Experimental:Whey protein in people with Fatigue and Inflammation, run by Brock University at 1 site in Canada.

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

This randomised double blind, placebo-controlled study examined the effects of post-exercise consumption of whey protein (PRO) or carbohydrate (CHO) on performance recovery, muscle damage and inflammatory cytokine responses following a high intensity interval swim (HIIS) in 10-17-year old male and female swimmers. Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Fatigue, Inflammation, Bone Resorption
What is being tested?
Experimental:Whey protein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
19 Dec 2016to 18 Sep 2018
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 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • competitive swimmers (swim competitively for a minimum of 2y)
  • male or female 11-17y
  • free from any medical conditions

Who cannot join

  • yes on medical screening questionnaire
  • not classified as a competitive swimmer (swim competitively for <2y)
  • outside the desired age range (<11 or >17)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Brock University

    Saint Catharines, Ontario, L2S 3A1

Other trials in Canada

About this study

Official title: Effects of Post-exercise Protein Supplementation on Performance Recovery, Muscle Damage, Inflammation and Bone Turnover in Adolescent Swimmers

This randomised double blind, placebo-controlled study examined the effects of post-exercise consumption of whey protein (PRO) or carbohydrate (CHO) on performance recovery, muscle damage and inflammatory cytokine responses following a high intensity interval swim (HIIS) in 10-17-year old male and female swimmers.

Read the detailed description

Study Procedures: All tests and measurements were performed during three visits at the given swim teams training/practice facility.

During Visit 1, participants were informed of all tests and procedures that will take place and were familiarised with all testing protocols. All anthropometric measurements were also performed during this meeting (see below). Visit one took ~ 60-90 minutes.

During visit 2, Participants arrived at the testing centre for 06:00h, provided a fasted venous blood sample (for biochemical markers - see below). Following the saliva and blood samples, a light breakfast (~300-400 kcal, depending on body mass) (e.g. banana, apple, plain granola bar, water etc.) was provided. Following breakfast (approximately 45-60 min),all participants performed a standardised warm-up in the pool (1000m - short course) followed by 5min of rest and the subsequent performance test in the form of a maximal 200m-front-crawl. Following the maximal 200m performance test, participants underwent a maximal high intensity interval swim protocol (HIIS). The HIIS consisted of 15 high-intensity swimming repetitions (5x100m, 5x50m and 5x25m at maximal intensity) with a work-to-rest ratio of 1:1. Immediately following the HIIS participants exited the pool and provided a second blood sample (blood samples were collected pre-, 30min, 2, 6 and 24h post-HIIS). This was then followed by the first supplement drink ~30-40. 1.5h after consuming the first supplement drink, participants returned to the pool to complete a second maximal 200m swim, followed by a blood test and received their second supplement drink. 1.5h following the supplement drink, a standardised vegetarian lunch was provided, 1.5h following lunch participant provided another blood sample and performed the final 200m swim of that day. Prior to departure participants were provided with a food record sheet to track all food consumption that evening and were instructed to return it to a study investigator the following day.

During visit 3, Participants returned to the testing location at 06:00h, provided a fasted Blood and saliva samples, were given the same breakfast as they received on day 2 and were administered a muscle soreness questionnaire. Following breakfast (approximately 45-60 min),all participants performed the same standardised warm-up as they did in day 2 (1000m - short course) followed by 5min of rest and the subsequent performance test in the form of a maximal 200m-front-crawl.

Groups and supplementation protocol - Participants matched into one of three groups: Protein (0.3g/kg - whey protein isolate), Carbohydrate (0.3g/kg - maltodextrin) or placebo control (flavoured water) (H2O), matched for age, sex and body mass. All groups consumed a total of two supplements, both the investigators and the participants themselves were blinded to the contents of the drink. All drinks were chocolate flavoured and served in black opaque protein shaker cups. For the protein and carbohydrate groups, each participant received an isoenergetic amount of supplement (2 x 0.3g/kg - whey protein isolate or maltodextrin) throughout the duration of the study at the given time-points outlined above.

Biochemical measurements:

Venous blood samples and a saliva sample will be collected on 5 separate occasions (pre-, 30min, 2, 6 and 24h post-HIIS). To control for circadian rhythm, the exercise session and related blood samples will be performed at the same time of day.

Venous blood samples were collected from the antecubital fossa of each participant using a standard venipuncture technique. Endocrine response such as anabolic/hormonal markers, inflammatory markers (cytokines - IL-6, IL-10, TNF-α) and indicators of muscle fatigue/damage (CK) were examined.

Being tested
Experimental:Whey protein, Active Comparator: Isoenergetic control - Carbohydrate, Placebo
Medical subject headings
Fatigue, Inflammation, Bone Resorption

What participants receive

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

  • Experimental:Whey proteinDietary supplement

    Each participant in the protein group received 2 protein drinks immediately following exercise. The supplement was given using a relative quantity of whey protein isolate (0.3g/kg) and was chocolate flavoured.

  • Active Comparator: Isoenergetic control - CarbohydrateDietary supplement

    Each participant in the carbohydrate group received 2 drinks immediately following exercise. The supplement was given using a relative quantity of maltodextrin (0.3g/kg), non-caloric chocolate flavouring was added to mask the drinks contents.

  • PlaceboOther

    Each participant in the water group received 2 drinks immediately following exercise. The water was provided in a similar volume using the same non-caloric chocolate flavouring as the other drinks.

Study groups in NCT04114045
Study groupRoleWhat they receive
Whey proteinExperimentalWhey protein isolate
Receives: Dietary Supplement: Experimental:Whey protein
Isoenergetic control - CarbohydrateActive comparatorCarbohydrate or maltodextrin
Receives: Dietary Supplement: Active Comparator: Isoenergetic control - Carbohydrate
Placebo control - WaterPlacebo comparatorWater - chocolate flavoured
Receives: Other: Placebo

What is being measured

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

  1. Performance recovery

    200m front crawl time (s) measured in short course pool (25m)

    Measured: 24 hours

  2. IL-6 (pg/ml)

    Myokine

    Measured: 24 hours

  3. IL-10 (pg/ml)

    Anti-inflammatory cytokine

    Measured: 24 hours

  4. TNF-alpha (pg/ml)

    Pro-inflammatory cytokines

    Measured: 24 hours

  5. Muscle damage

    Creatine kinase activity (u/L)

    Measured: 24 hours

  6. Bone formation marker

    Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml)

    Measured: 24 hours

  7. Bone resorption marker

    Carboxy-terminal collagen crosslinks, CTXI (ng/ml)

    Measured: 24 hours

Secondary outcomes (2)
  1. Bone turnover balance

    Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI)

    Measured: 24 hours

  2. Rate of Bone turnover

    Rate of bone formation and resorption calculated as √[MoMF(square) + MoMR(square)

    Measured: 24 hours

Timeline

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

  1. First posted3 Oct 2019
  2. Study start19 Dec 2016
  3. Primary completion24 May 2018
  4. Study completion18 Sep 2018

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants were divided into three groups: PRO (0.3g/kg - whey protein isolate), CHO (0.3g/kg - maltodextrin) or placebo control (H2O), matched for age, sex and body mass
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04114045
Sponsor's protocol ID
16-279 Klentrou
Status last verified
May 2022
First submitted
30 Sep 2019
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McKinlay BJ, Theocharidis A, Adebero T, Kurgan N, Fajardo VA, Roy BD, Josse AR, M Logan-Sprenger H, Falk B, Klentrou P. Effects of Post-Exercise Whey Protein Consumption on Recovery Indices in Adolescent Swimmers. Int J Environ Res Public Health. 2020 Oct 23;17(21):7761. doi: 10.3390/ijerph17217761.

    PubMed 33114186
  • Theocharidis A, McKinlay BJ, Vlachopoulos D, Josse AR, Falk B, Klentrou P. Effects of post exercise protein supplementation on markers of bone turnover in adolescent swimmers. J Int Soc Sports Nutr. 2020 Apr 15;17(1):20. doi: 10.1186/s12970-020-00350-z.

    PubMed 32293471
  • Sanderson M, McKinlay BJ, Theocharidis A, Kouvelioti R, Falk B, Klentrou P. Changes in Inflammatory Cytokines and Irisin in Response to High Intensity Swimming in Adolescent versus Adult Male Swimmers. Sports (Basel). 2020 Dec 1;8(12):157. doi: 10.3390/sports8120157.

    PubMed 33271764

Questions about this trial

What is this clinical trial studying?

A study testing Experimental:Whey protein in people with Fatigue and Inflammation, run by Brock University at 1 site in Canada.

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 3 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 2 Jun 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 Canada. 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?

Performance recovery (time frame: 24 hours). The study lists 7 primary outcomes in all. 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 NCT04114045, 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 2 Jun 2022.

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