NCT03947801

Brief Summary

Our proposed study is a 5-d double-blind randomised cross-over trial, seeking to simulate a training identification camp in competitive adolescent soccer players The purpose of the proposed study is to investigate whether increased protein consumption by Greek yogurt, compared to an isoenergetic carbohydrate (CHO) control supplement, consumed immediately following exercise training, prior to sleep and between breakfast and lunch, for a week during an intense training period (high volume, high intensity) will:

  • Attenuate the pro-inflammatory response (cytokines, acute phase proteins)
  • Reduced the severity of muscle damage and impairment (creatine kinase)
  • Maintain performance Secondary outcome measures: \- Increase bone turnover (in favour of formation)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2019

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 8, 2019

Last Update Submit

May 29, 2022

Conditions

Inflammatory ResponseSports Performance

Keywords

Greek YogurtAdolescent Athletes

Outcome Measures

Primary Outcomes (17)

  • Body mass (kg)

    Anthropometric measures

    8 weeks

  • Height (cm)

    Anthropometric measures

    8 weeks

  • Seated height (cm)

    Used to calculate maturity offset in years from peak height velocity

    8 weeks

  • Body fat (%)

    Body composition

    8 weeks

  • Rate of perceived exertion

    1-10 scale of perceived exertion

    8 weeks

  • Serum concentrations of BAP (ng/ml)

    Bone formation marker

    8 weeks

  • Serum concentrations of PINP (ng/ml)

    Bone formation marker

    8 weeks

  • Serum concentrations of OPG (pg/ml)

    Bone formation marker

    8 weeks

  • Serum concentrations of CTX (ng/ml)

    Bone resorption marker

    8 weeks

  • Serum concentrations of TRAP (ng/ml)

    Bone resorption marker

    8 weeks

  • Serum concentrations of RANKL (pg/ml)

    Bone resorption marker

    8 weeks

  • Plasma concentrations of irisin (ng/ml)

    Plasma concentrations of pro-and-anti-inflammatory cytokines

    8 weeks

  • Plasma concentrations of IL-6 (pg/ml)

    Plasma concentrations of pro-and-anti-inflammatory cytokines

    8 weeks

  • Plasma concentrations of IL-10 (pg/ml)

    Plasma concentrations of pro-and-anti-inflammatory cytokines

    8 weeks

  • Plasma concentrations of TNF-alpha (pg/ml)

    Plasma concentrations of pro-and-anti-inflammatory cytokines

    8 weeks

  • Plasma concentrations of CRP (pg/ml)

    Plasma concentrations of pro-and-anti-inflammatory cytokines

    8 weeks

  • Plasma concentration of creatine kinase (U/L)

    Muscle damage

    8 weeks

Secondary Outcomes (6)

  • Serum concentration of IGF-1 (pg/ml)

    8 weeks

  • Plasma concentration of TBARS

    8 weeks

  • Plasma concentration of ROS

    8 weeks

  • Saliva concentrations of cortisol (ug/dl)

    8 weeks

  • Saliva concentrations of testosterone (pg/ml)

    8 weeks

  • +1 more secondary outcomes

Other Outcomes (4)

  • Aerobic Capacity - Beep Test

    8 weeks

  • Maximal sprint ability

    8 weeks

  • Explosive leg power - Vertical jump performance

    8 weeks

  • +1 more other outcomes

Study Arms (2)

Greek Yogurt condition

EXPERIMENTAL

3x 160g of 0% Plain Greek yogurt (\~115 kcals, 17 g protein, \~11.5 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.

Other: Greek Yogurt

Isoenergetic condition - Carbohydrate

PLACEBO COMPARATOR

3x 30g of isoenergetic CHO supplement (\~115 kcal, 0.04 g protein, \~28.6 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.

Other: Isoenergetic carbohydrate

Interventions

Greek YogurtOTHER

Female competitive soccer players (11-16y) will consume 0% plain Greek yogurt immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.

Greek Yogurt condition
Isoenergetic carbohydrateOTHER

Female competitive soccer players (11-16y) will consume an isoenergetic carbohydrate supplement immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.

Isoenergetic condition - Carbohydrate

Eligibility Criteria

Age11 Years - 16 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale adolescent competitive soccer players
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participant are female within the desired age ranges (11-16y)
  • Participants are competitive soccer players
  • Previous participation in high-performance training environment (periodization)

You may not qualify if:

  • Participant is not female or falls outside of the desired age ranges (11-16y)
  • Chronic/frequent use of medications that could affect inflammatory function - NSAIDS or Corticosteroids.
  • Musculoskeletal injury - resulting in the inability to train and/or perform the baseline/post testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elite soccer Development

Welland, Ontario, L3C 1M6, Canada

Location

Related Publications (2)

  • McKinlay BJ, Wallace PJ, Olansky S, Woods S, Kurgan N, Roy BD, Josse AR, Falk B, Klentrou P. Intensified training in adolescent female athletes: a crossover study of Greek yogurt effects on indices of recovery. J Int Soc Sports Nutr. 2022 Mar 22;19(1):17-33. doi: 10.1080/15502783.2022.2044732. eCollection 2022.

    PMID: 35599913RESULT

  • Klentrou P, McKee K, McKinlay BJ, Kurgan N, Roy BD, Falk B. Circulating Levels of Bone Markers after Short-Term Intense Training with Increased Dairy Consumption in Adolescent Female Athletes. Children (Basel). 2021 Oct 25;8(11):961. doi: 10.3390/children8110961.

    PMID: 34828674RESULT

Study Officials

  • Panagiota Klentrou, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 13, 2019

Study Start

July 1, 2019

Primary Completion

November 23, 2019

Study Completion

November 23, 2019

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)