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Effects of Post-exercise Protein Supplementation in Young Athletes

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ClinicalTrials.gov Identifier: NCT04114045
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
PKlentrou, Brock University

Brief 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.

Condition or disease Intervention/treatment Phase
Fatigue Inflammation Bone Resorption Dietary Supplement: Experimental:Whey protein Dietary Supplement: Active Comparator: Isoenergetic control - Carbohydrate Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: One member of the research team whom did not have direct contact with participant during performance testing, matched participants for age, sex and body mass into one of three groups (protein, carbohydrate or placebo/water). This member of the research team also prepared and distributed all the research supplements in a sealed black opaque containers
Primary Purpose: Treatment
Official Title: Effects of Post-exercise Protein Supplementation on Performance Recovery, Muscle Damage, Inflammation and Bone Turnover in Adolescent Swimmers
Actual Study Start Date : December 19, 2016
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : September 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Whey protein
Whey protein isolate
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
Carbohydrate or maltodextrin
Dietary Supplement: 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.

Placebo Comparator: Placebo control - Water
Water - chocolate flavoured
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.




Primary Outcome Measures :
  1. Performance recovery [ Time Frame: 24 hours ]
    200m front crawl time (s) measured in short course pool (25m)

  2. IL-6 (pg/ml) [ Time Frame: 24 hours ]
    Myokine

  3. IL-10 (pg/ml) [ Time Frame: 24 hours ]
    Anti-inflammatory cytokine

  4. TNF-alpha (pg/ml) [ Time Frame: 24 hours ]
    Pro-inflammatory cytokines

  5. Muscle damage [ Time Frame: 24 hours ]
    Creatine kinase activity (u/L)

  6. Bone formation marker [ Time Frame: 24 hours ]
    Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml)

  7. Bone resorption marker [ Time Frame: 24 hours ]
    Carboxy-terminal collagen crosslinks, CTXI (ng/ml)


Secondary Outcome Measures :
  1. Bone turnover balance [ Time Frame: 24 hours ]
    Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI)

  2. Rate of Bone turnover [ Time Frame: 24 hours ]
    Rate of bone formation and resorption calculated as √[MoMF(square) + MoMR(square)



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114045


Locations
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Canada, Ontario
Brock University
Saint Catharines, Ontario, Canada, L2S 3A1
Sponsors and Collaborators
Brock University
Investigators
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Principal Investigator: Panagiota Klentrou, PhD Brock University

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Responsible Party: PKlentrou, Professor and Associate Dean, Brock University
ClinicalTrials.gov Identifier: NCT04114045     History of Changes
Other Study ID Numbers: 16-279 Klentrou
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Resorption
Inflammation
Fatigue
Pathologic Processes
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases