Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000865213
Ethics application status
Approved
Date submitted
14/05/2018
Date registered
22/05/2018
Date last updated
27/08/2020
Date data sharing statement initially provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different sports beverages on recovery from endurance exercise.
Scientific title
The role of differing post-exercise beverages on markers of physiological and psychophysiological recovery in elite and habitually-trained athletes.
Secondary ID [1] 294872 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ExerRec
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery from prolonged physical exertion 307823 0
Condition category
Condition code
Diet and Nutrition 306870 306870 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 306887 306887 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 306888 306888 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The food and fluid provided during the post-exercise period plays an essential role in recovery and adaptation processes. There has been a considerable amount of research investigating the ideal quantity and quality of nutrients (e.g., carbohydrate, protein, electrolytes and water) for optimising the key recovery processes (i.e., repair, healing, growth, glycogen re-synthesis and rehydration) individually. This has lead to the development of recovery nutrition guidelines and recommendations, as well as commercially available recovery supplements.

Considering dairy milk has similar nutritional properties to recovery nutrition guidelines and recommendations, there is emerging evidence suggesting that dairy milk has the potential to optimise recovery from prolonged exercise. Therefore, the aim of this study is to compare the effects of dairy milk to other sports recovery beverages, on aspects of recovery.

Participants will complete any 2 out of the 4 trials in a randomised, repeated measures design, with 14 days washout between trials, such that participant numbers are equally distributed across all four trials.

Prior to experimental trials, participants will perform an exhaustive exercise test on a treadmill to determine their VO2 maximal capacity. This test will also serve to familiarise participants with the laboratory.

All experimental trials will involve a 2-hour exercise protocol, which is a modified version of the LIST test. After self paced warm-up (10min- not included in 2h), the participant will then run for 3 x 5min blocks (3min30sec jog at 55-60 percent VO¬2 max, 1min run at 70-75 percent VO2 max, and 30sec hard at 80-85 percent VO2 max) then perform 20 plyometric jumps (remaining time walking at 6km/h). This will be repeated until 2 hours (i.e. 6x20minute blocks). Ambient conditions will be 20-25 degrees celsius and 30-40 percent relative humidity.

After exercise, participants will be given 1 of 4 recovery beverages (in randomised, double-blinded fashion)

Trial 1: UHT tetra-pack chocolate flavoured dairy milk
Trial 2: Commercially available protein recovery beverage
Trial 3: Commercially available carbohydrate-electrolyte beverage
Trial 4: Low carbohydrate high protein recovery beverage

The beverage will be given in 3 equal boluses, every 10 minutes beginning immediately post-exercise. The volume will dependent on participant body-weight, to provide 1.2g of carbohydrate per kilogram bodyweight of the Trial 1 beverage. All other trial beverages will be matched for volume. Over the remaining recovery period, participants will be given additional water to provide a total volume of 35mL fluid per kilogram of bodyweight. Participants will be observed during the feeding period to ensure participants consume entire dose. The exercise protocol and beverage delivery will be administered by a dietitian.

Trained researchers will closely monitor participants over a 4-hour recovery period. During this time, blood, breath and muscle biopsy samples and questionnaires will be collected to assess recovery from exercise.

The following morning, participants will return to the lab to assess Psychophysiological parameters and exercise performance test.

Throughout the intervention period (24 hours prior to testing through to performance testing) participants will be provided with standardised meals. Compliance will be assessed using food diaries and verbal confirmation.
Intervention code [1] 301186 0
Treatment: Other
Comparator / control treatment
Trial 3: carbohydrate-electrolye beverage
Control group
Active

Outcomes
Primary outcome [1] 305862 0
Muscle glycogen re-synthesis assessed from muscle biopsies of vastus lateralis muscle
Timepoint [1] 305862 0
Immediately and 120 minutes post-exercise
Primary outcome [2] 305863 0
Muscle protein synthesis assessed from muscle biopsies of vastus lateralis muscle
Timepoint [2] 305863 0
Immediately and 120 minutes post-exercise
Primary outcome [3] 305864 0
Total body water assessed using bioeletrical impedance
Timepoint [3] 305864 0
Pre-exercise and immediately, 120 [primary time point] and 240 minutes post-exercise, and before distance test (day 2)
Secondary outcome [1] 346824 0
Breath hydrogen concentration assessed using gas sensitive analyser
Timepoint [1] 346824 0
Pre-exercise and immediately, 30, 60, 90, 120, 150, 180, 210 and 240 minutes post-exercise
Secondary outcome [2] 346825 0
Circulating leukocytes count from venous blood sample using automated cell counter
Timepoint [2] 346825 0
Pre-exercise and immediately, 120 and 240 minutes post-exericse
Secondary outcome [3] 346826 0
Circulating lymphocyte count from venous blood sample using automated cell counter
Timepoint [3] 346826 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [4] 346827 0
Circulating neutrophil count from venous blood sample using automated cell counter
Timepoint [4] 346827 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [5] 346828 0
Plasma osmolality value from venous blood sample using freezing point depression
Timepoint [5] 346828 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [6] 346829 0
Fatty acid binding protein concentration from venous blood sample
Timepoint [6] 346829 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [7] 346830 0
Blood glucose level from venous blood sample assessed using hand held monitor
Timepoint [7] 346830 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [8] 346831 0
Blood glucose level from capillary sample (finger prick) using hand held monitor
Timepoint [8] 346831 0
30, 60 and 90 minutes post-exercise
Secondary outcome [9] 346832 0
Plasma insulin concentration from venous blood sample assessed using ELISA kit
Timepoint [9] 346832 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [10] 346835 0
Haemoglobin concentration from venous blood sample using portable haemoglobin analyser
Timepoint [10] 346835 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise
Secondary outcome [11] 346836 0
Breath methane concentration assessed using gas sensitive analyser
Timepoint [11] 346836 0
Pre-exercise and immediately, 30, 60, 90, 120, 150, 180, 210 and 240 minutes post-exercise
Secondary outcome [12] 346837 0
Subjective rating of gastro-intestinal symptoms using modified 10 point likert scale questionnaire designed for this study
Timepoint [12] 346837 0
Pre-exercise, every 20 minutes during exercise and every 30 minutes post-exercise, and before and after distance test (day 2)
Secondary outcome [13] 346838 0
Urine output volume collected and measured in sterile 2L containers
Timepoint [13] 346838 0
During exercise and 2 and 4 hours post-exercise
Secondary outcome [14] 346839 0
Nude body mass assessed using digital scales
Timepoint [14] 346839 0
Pre-exercise and immediately, 120 and 240 minutes post-exercise, and before and after distance test (day 2)
Secondary outcome [15] 346840 0
Mood measured using profile of mood states questionnaire
Timepoint [15] 346840 0
Pre-exercise (day 1)
Secondary outcome [16] 346841 0
Muscle soreness assessed using 10 point visual analogue scale
Timepoint [16] 346841 0
Before and after distance test (day 2)
Secondary outcome [17] 346842 0
Distance performance test assessed by measuring the distance participant is able to run on treadmill in 1 hour
Timepoint [17] 346842 0
Morning after exercise trial (day 2)
Secondary outcome [18] 346843 0
Intestinal microbiome bacterial total abundance and diversity through PCR and s16 bacterial gene sequencing (faecal sample)
Timepoint [18] 346843 0
Pre-exercise (day 1)
Secondary outcome [19] 346851 0
Palatability of recovery beverage assessed using modified VAS sensory questionnaire, designed for the purpose of this study.
Timepoint [19] 346851 0
30 minute post-exercise (Day 1)

Eligibility
Key inclusion criteria
Habitually trained and elite level athletes.
Physically able to run for 2 hours.
Physically able to run at 16km/h for at least 30 seconds.
Physically healthy with no known disease or injury that would prevent them from completing the protocol.
Fitness status: VO2max greater than or equal to 50ml/kg/min
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Untrained/sedentary individuals (no structured, regular training program)
Older/elderly sedentary individuals
Disease, condition or injury including:
• Fever, cough, cold, or suffer from fainting spells or dizziness.
• Suspended training due to a joint or muscle injury.
• Known history of medical disorders, i.e. high blood pressure, heart or lung disease.
• Hyper/hypothermia, heat exhaustion, or any other heat or cold disorder.
• Anaphylactic shock symptoms with needles, probes, or other medical-type equipment.
• Chronic or acute symptoms of gastrointestinal bacterial infections.
• History of infectious disease (e.g. HIV, Hepatitis B)
Fitness status: VO2max <50ml/kg/min

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to the order of the 2 interventions given in this crossover trial, but allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Microsoft Excel and the Statistical Package for the Social Sciences (SPSS) software will be utilised for statistical analysis of results

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2018
Actual
14/06/2018
Date of last participant enrolment
Anticipated
5/11/2019
Actual
6/12/2019
Date of last data collection
Anticipated
13/12/2019
Actual
18/12/2019
Sample size
Target
32
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299459 0
Commercial sector/Industry
Name [1] 299459 0
Lion Drinks and Dairy
Country [1] 299459 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Australia
Country
Australia
Secondary sponsor category [1] 298761 0
None
Name [1] 298761 0
Address [1] 298761 0
Country [1] 298761 0
Other collaborator category [1] 280105 0
Government body
Name [1] 280105 0
Australian Institute of Sport
Address [1] 280105 0
Leverrier St, Bruce ACT 2617
Country [1] 280105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300365 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300365 0
Ethics committee country [1] 300365 0
Australia
Date submitted for ethics approval [1] 300365 0
12/03/2018
Approval date [1] 300365 0
09/04/2018
Ethics approval number [1] 300365 0
2018-12799-17725

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83418 0
Dr Ricardo Costa
Address 83418 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 83418 0
Australia
Phone 83418 0
+61 (3) 9905 6861
Fax 83418 0
Email 83418 0
[email protected]
Contact person for public queries
Name 83419 0
Ricardo Costa
Address 83419 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 83419 0
Australia
Phone 83419 0
+61 (3) 9905 6861
Fax 83419 0
Email 83419 0
[email protected]
Contact person for scientific queries
Name 83420 0
Ricardo Costa
Address 83420 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 83420 0
Australia
Phone 83420 0
+61 (3) 9905 6861
Fax 83420 0
Email 83420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.