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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04114045
Other study ID # 16-279 Klentrou
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2016
Est. completion date September 18, 2018

Study information

Verified date May 2022
Source Brock University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 18, 2018
Est. primary completion date May 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Experimental:Whey protein
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
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.
Other:
Placebo
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.

Locations

Country Name City State
Canada Brock University Saint Catharines Ontario

Sponsors (1)

Lead Sponsor Collaborator
Brock University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 — View Citation

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). pii: E157. doi: 10. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance recovery 200m front crawl time (s) measured in short course pool (25m) 24 hours
Primary IL-6 (pg/ml) Myokine 24 hours
Primary IL-10 (pg/ml) Anti-inflammatory cytokine 24 hours
Primary TNF-alpha (pg/ml) Pro-inflammatory cytokines 24 hours
Primary Muscle damage Creatine kinase activity (u/L) 24 hours
Primary Bone formation marker Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml) 24 hours
Primary Bone resorption marker Carboxy-terminal collagen crosslinks, CTXI (ng/ml) 24 hours
Secondary Bone turnover balance Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI) 24 hours
Secondary Rate of Bone turnover Rate of bone formation and resorption calculated as v[MoMF(square) + MoMR(square) 24 hours
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