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Effects of Post-exercise Protein Supplementation in Young Athletes

Primary Purpose

Fatigue, Inflammation, Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Experimental:Whey protein
Active Comparator: Isoenergetic control - Carbohydrate
Placebo
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Whey protein

Isoenergetic control - Carbohydrate

Placebo control - Water

Arm Description

Whey protein isolate

Carbohydrate or maltodextrin

Water - chocolate flavoured

Outcomes

Primary Outcome Measures

Performance recovery
200m front crawl time (s) measured in short course pool (25m)
IL-6 (pg/ml)
Myokine
IL-10 (pg/ml)
Anti-inflammatory cytokine
TNF-alpha (pg/ml)
Pro-inflammatory cytokines
Muscle damage
Creatine kinase activity (u/L)
Bone formation marker
Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml)
Bone resorption marker
Carboxy-terminal collagen crosslinks, CTXI (ng/ml)

Secondary Outcome Measures

Bone turnover balance
Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI)
Rate of Bone turnover
Rate of bone formation and resorption calculated as √[MoMF(square) + MoMR(square)

Full Information

First Posted
September 30, 2019
Last Updated
May 29, 2022
Sponsor
Brock University
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1. Study Identification

Unique Protocol Identification Number
NCT04114045
Brief Title
Effects of Post-exercise Protein Supplementation in Young Athletes
Official Title
Effects of Post-exercise Protein Supplementation on Performance Recovery, Muscle Damage, Inflammation and Bone Turnover in Adolescent Swimmers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
September 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Inflammation, Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein
Arm Type
Experimental
Arm Description
Whey protein isolate
Arm Title
Isoenergetic control - Carbohydrate
Arm Type
Active Comparator
Arm Description
Carbohydrate or maltodextrin
Arm Title
Placebo control - Water
Arm Type
Placebo Comparator
Arm Description
Water - chocolate flavoured
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental:Whey protein
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Active Comparator: Isoenergetic control - Carbohydrate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Performance recovery
Description
200m front crawl time (s) measured in short course pool (25m)
Time Frame
24 hours
Title
IL-6 (pg/ml)
Description
Myokine
Time Frame
24 hours
Title
IL-10 (pg/ml)
Description
Anti-inflammatory cytokine
Time Frame
24 hours
Title
TNF-alpha (pg/ml)
Description
Pro-inflammatory cytokines
Time Frame
24 hours
Title
Muscle damage
Description
Creatine kinase activity (u/L)
Time Frame
24 hours
Title
Bone formation marker
Description
Procollagen type 1 intact N-terminal propeptide, PINP (ng/ml)
Time Frame
24 hours
Title
Bone resorption marker
Description
Carboxy-terminal collagen crosslinks, CTXI (ng/ml)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Bone turnover balance
Description
Balance between bone formation and resorption calculated from the ratio of Median (PINP)/Median(CTXI)
Time Frame
24 hours
Title
Rate of Bone turnover
Description
Rate of bone formation and resorption calculated as √[MoMF(square) + MoMR(square)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiota Klentrou, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
Saint Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33114186
Citation
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):
Results Reference
result
PubMed Identifier
32293471
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.
Results Reference
result
PubMed Identifier
33271764
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):157. doi: 10.3390/sports8120157.
Results Reference
result

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Effects of Post-exercise Protein Supplementation in Young Athletes

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