- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114045
Effects of Post-exercise Protein Supplementation in Young Athletes
Effects of Post-exercise Protein Supplementation on Performance Recovery, Muscle Damage, Inflammation and Bone Turnover in Adolescent Swimmers
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Saint Catharines, Ontario, Canada, L2S 3A1
- Brock University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- competitive swimmers (swim competitively for a minimum of 2y)
- male or female 11-17y
- free from any medical conditions
Exclusion Criteria:
- yes on medical screening questionnaire
- not classified as a competitive swimmer (swim competitively for <2y)
- outside the desired age range (<11 or >17)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whey protein
Whey protein isolate
|
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 - Carbohydrate
Carbohydrate or maltodextrin
|
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.
|
|
Placebo Comparator: Placebo control - Water
Water - chocolate flavoured
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance recovery
Time Frame: 24 hours
|
200m front crawl time (s) measured in short course pool (25m)
|
24 hours
|
|
IL-6 (pg/ml)
Time Frame: 24 hours
|
Myokine
|
24 hours
|
|
IL-10 (pg/ml)
Time Frame: 24 hours
|
Anti-inflammatory cytokine
|
24 hours
|
|
TNF-alpha (pg/ml)
Time Frame: 24 hours
|
Pro-inflammatory cytokines
|
24 hours
|
|
Muscle damage
Time Frame: 24 hours
|
Creatine kinase activity (u/L)
|
24 hours
|
|
Bone formation marker
Time Frame: 24 hours
|
Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml)
|
24 hours
|
|
Bone resorption marker
Time Frame: 24 hours
|
Carboxy-terminal collagen crosslinks, CTXI (ng/ml)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone turnover balance
Time Frame: 24 hours
|
Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI)
|
24 hours
|
|
Rate of Bone turnover
Time Frame: 24 hours
|
Rate of bone formation and resorption calculated as √[MoMF(square) + MoMR(square)
|
24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. Erratum In: Int J Environ Res Public Health. 2022 Dec 06;19(23):
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-279 Klentrou
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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