Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03947801
Other study ID # 18-289-Klentrou
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date November 23, 2019

Study information

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

Clinical Trial 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)


Description:

The proposed study is a randomized, double-blinded, cross-over trial. The protocol will consist of an information session, two identical training camps consisting of 5 consecutive days of intensified soccer training, differing only by nutritional intervention, and identical pre-and post-training session testing. Each testing block will be separated by 28-d to allow for an adequate wash-out and recovery period, during which participants would resume their regular soccer activities Study Procedures: All tests and measurements will be performed within eight-weeks. Specifically, participants will attend 1 information session, two identical pre- and post- training/testing sessions and two identical soccer specific training camps. Information session: One week prior to the initial soccer specific training camp, participants will be informed of all tests and procedures that will take place and be familiarized with all testing protocols. Pre- and Post-training testing: All participants will be tested twice: on the day before (pre) and day following (post) the 5-d soccer specific training camp. Specifically, Participants, will arrive at the University for pre- and post-training testing in the morning at the same time. Body composition measurements will be performed (e.g., standing/seated height, mass, % body fat) followed by fasted venous blood and saliva sampling. A standardized breakfast would then be provided followed by an adequate rest and digest period before performance testing (~1.5h). Performance testing would include a battery of soccer specific tests that cover, power (counter-movement jump, broad jump), speed (10m and 20m sprint), agility (modified 5-0-5) and aerobic capacity (beep-test). During both pre-and-post-testing sessions participants would consume the same standardised breakfast and perform the same tests in the same order for consistency amongst trials which would be repeated between the two testing blocks. Soccer training: The simulated 5-d soccer-specific training will be structured to mimic a heavy-volume, high-intensity training camp. Training sessions would occur at the same time each day in the evening for consistency. Drills/exercises will be administered by a certified technical soccer coach and knowledgeable training staff. Each session will began with a 15 min dynamic warm-up followed by 90 min of soccer-specific training, ending with a 15 min cool-down. The 90 min of soccer-specific training will be performed at maximal effort and consist of agility, sprinting and plyometric exercises as well as ball-handling, small-sided games (rondo) and shooting. Following each training session rating of perceived exertion (RPE) will be measured as an indicator of internal load. Food/Drink supplement consumption: During the study, three servings of 160 g of 0% plain GY (~115 kcals, 17 g protein, ~11.5 g carbs, 0 fat), or 30 g of isoenergetic CHO (~115 kcal, 0.04 g protein, ~28.6 g carbs, 0 fat) will be provided to participants immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. The yogurt will be sweetened or flavored with a non-caloric vanilla flavouring to match the taste of the control supplement. The CHO control supplement group will be an isoenergetic dose of a maltodextrin-based semi-solid pudding. This product will be made from non-fat vanilla pudding powder (1 part), maltodextrin (4 parts) and water. This product has been designed to resemble the consistency and texture of Greek yogurt. Measurements Questionnaires: Participant Screening and Medical History, Training History, Food frequency Questionnaire (FFQ), sessional RPE. Anthropometric and body composition measurements: height, seated height, body mass and body fat percentage (%) using bioelectrical impedance analysis (BIA, InBody520; Biospace Co., Ltd., Seoul, S. Korea). Somatic maturity: maturity offset (years from the age of peak height velocity) will be calculated based on height, seated height and weight measurements. Exercise performance: will be examined prior to, as well as following each training intervention week. These tests are common in soccer and athletes are familiar with them. To limit confounding exercise influence on both biochemical and performance parameters, participants will be asked to refrain from other activities outside those prescribed to them during the training sessions and 48h prior to the initial pre-assessment visit. Venous blood and saliva samples: will be collected on 4 separate occasions (24h prior and 24h following the last training session of each training intervention week). To control for circadian rhythm, the exercise session and related blood and saliva samples will be conducted at the same time of day. Saliva samples will be used to examine endocrine response. Venous blood samples will be used to examine inflammatory markers (cytokines - IL-6, IL-10 and TNF-α), c-reactive protein (CRP), IGF-I and indicators of muscle fatigue/damage (CK). Secondary measures may include irisin, oxidative stress (TBARS and ROS) and bone turnover by examining circulating markers of bone formation (PINP, Osteocalcin, BAP, OPG) and of bone resorption (CTX, TRAP, RANKL).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 23, 2019
Est. primary completion date November 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria: - Participant are female within the desired age ranges (11-16y) - Participants are competitive soccer players - Previous participation in high-performance training environment (periodization) Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Greek Yogurt
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.
Isoenergetic carbohydrate
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.

Locations

Country Name City State
Canada Elite soccer Development Welland Ontario

Sponsors (1)

Lead Sponsor Collaborator
Brock University

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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). pii: 961. doi: 10.3390/ch — View Citation

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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Aerobic Capacity - Beep Test Aerobic capacity using the - Beep test; units - distance (m) 8 weeks
Other Maximal sprint ability Maximal sprint ability using a 20 m sprint test; units - time (s) 8 weeks
Other Explosive leg power - Vertical jump performance Explosive leg power using the counter-movement jump; units - height (cm) 8 weeks
Other Agility and Quickness Agility using the 5-10-5 pro-agility test; units - time (s) 8 weeks
Primary Body mass (kg) Anthropometric measures 8 weeks
Primary Height (cm) Anthropometric measures 8 weeks
Primary Seated height (cm) Used to calculate maturity offset in years from peak height velocity 8 weeks
Primary Body fat (%) Body composition 8 weeks
Primary Rate of perceived exertion 1-10 scale of perceived exertion 8 weeks
Primary Serum concentrations of BAP (ng/ml) Bone formation marker 8 weeks
Primary Serum concentrations of PINP (ng/ml) Bone formation marker 8 weeks
Primary Serum concentrations of OPG (pg/ml) Bone formation marker 8 weeks
Primary Serum concentrations of CTX (ng/ml) Bone resorption marker 8 weeks
Primary Serum concentrations of TRAP (ng/ml) Bone resorption marker 8 weeks
Primary Serum concentrations of RANKL (pg/ml) Bone resorption marker 8 weeks
Primary Plasma concentrations of irisin (ng/ml) Plasma concentrations of pro-and-anti-inflammatory cytokines 8 weeks
Primary Plasma concentrations of IL-6 (pg/ml) Plasma concentrations of pro-and-anti-inflammatory cytokines 8 weeks
Primary Plasma concentrations of IL-10 (pg/ml) Plasma concentrations of pro-and-anti-inflammatory cytokines 8 weeks
Primary Plasma concentrations of TNF-alpha (pg/ml) Plasma concentrations of pro-and-anti-inflammatory cytokines 8 weeks
Primary Plasma concentrations of CRP (pg/ml) Plasma concentrations of pro-and-anti-inflammatory cytokines 8 weeks
Primary Plasma concentration of creatine kinase (U/L) Muscle damage 8 weeks
Secondary Serum concentration of IGF-1 (pg/ml) Serum concentration of IGF-1 8 weeks
Secondary Plasma concentration of TBARS Oxidative stress 8 weeks
Secondary Plasma concentration of ROS Oxidative stress 8 weeks
Secondary Saliva concentrations of cortisol (ug/dl) Endocrine response 8 weeks
Secondary Saliva concentrations of testosterone (pg/ml) Endocrine response 8 weeks
Secondary Oxidative stress Plasma concentrations of markers of oxidative stress 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Not yet recruiting NCT06434701 - Severe COVID-19 Infection in Children Presenting to EDs in Israel and England N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT04608643 - Inflammatory Markers and Cbc Indices in Severely Malnourished Children
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Recruiting NCT01417923 - The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain Phase 4
Terminated NCT01377441 - Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia. Phase 4
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Terminated NCT00578578 - Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels Phase 4
Recruiting NCT04611334 - The Effects of HRV Biofeedback on Chronic Kidney Disease Patient. N/A
Recruiting NCT03510702 - SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Completed NCT03445234 - Blueberries, Bananas, Exercise Recovery N/A
Not yet recruiting NCT06450704 - Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders N/A
Not yet recruiting NCT05754294 - Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Completed NCT04864600 - CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles N/A
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4