NCT04114045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

September 30, 2019

Last Update Submit

May 29, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Performance recovery

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

    24 hours

  • IL-6 (pg/ml)

    Myokine

    24 hours

  • IL-10 (pg/ml)

    Anti-inflammatory cytokine

    24 hours

  • TNF-alpha (pg/ml)

    Pro-inflammatory cytokines

    24 hours

  • Muscle damage

    Creatine kinase activity (u/L)

    24 hours

  • Bone formation marker

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

    24 hours

  • Bone resorption marker

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

    24 hours

Secondary Outcomes (2)

  • Bone turnover balance

    24 hours

  • Rate of Bone turnover

    24 hours

Study Arms (3)

Whey protein

EXPERIMENTAL

Whey protein isolate

Dietary Supplement: Experimental:Whey protein

Isoenergetic control - Carbohydrate

ACTIVE COMPARATOR

Carbohydrate or maltodextrin

Dietary Supplement: Active Comparator: Isoenergetic control - Carbohydrate

Placebo control - Water

PLACEBO COMPARATOR

Water - chocolate flavoured

Other: Placebo

Interventions

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.

Whey protein

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.

Isoenergetic control - Carbohydrate
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.

Placebo control - Water

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

Saint Catharines, Ontario, L2S 3A1, Canada

Location

Related 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 23;17(21):7761. doi: 10.3390/ijerph17217761.

  • 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.

MeSH Terms

Conditions

FatigueInflammationBone Resorption

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Panagiota Klentrou, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 3, 2019

Study Start

December 19, 2016

Primary Completion

May 24, 2018

Study Completion

September 18, 2018

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations