Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001461886
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
26/10/2021
Date last updated
26/10/2021
Date data sharing statement initially provided
26/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of probiotic supplementation in athletes
Scientific title
The Effects of probiotic supplementation on running performance in men athletes
Secondary ID [1] 304648 0
Nil known
Universal Trial Number (UTN)
NA
Trial acronym
PREP study
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal 322594 0
Condition category
Condition code
Musculoskeletal 320209 320209 0 0
Normal musculoskeletal and cartilage development and function
Respiratory 320422 320422 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 weeks of daily supplementation of NZMP PREP capsule containing 12 billion CFU probiotics. 3 weeks washout between cross-over conditions.
Intervention code [1] 320996 0
Treatment: Other
Comparator / control treatment
4 weeks of daily supplementation of capsule containing maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 328080 0
Running performance in the heat measured by time trial
Timepoint [1] 328080 0
after 4 weeks of intervention
Secondary outcome [1] 397525 0
Mucosal Immunity measured by salivary IgA post exercise
Timepoint [1] 397525 0
at 4 weeks

Eligibility
Key inclusion criteria
Healthy, fit men aged 18-45 years. With running as one component of their exercise regime
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-smokers, no antibiotics, probiotic supplements, or select fermented dairy for 3 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a priori power analyses the sample size N was computed as a function of the required power level (1-ß err prob = 0.90), the prespecified significance level (a err prob = 0.05), and the population effect size to be detected with probability (dz = 0.5786865 determined from a similar study (Shing et al, 2014)) run in G Power (Faul et al, 2007), results below.
t tests - Means: Difference between two dependent means (matched pairs)
Analysis: A priori: Compute required sample size
Input: Tail(s) = One
Effect size dz = 0.5786865
a err prob = 0.05
Power (1-ß err prob) = 0.90
Output: Noncentrality parameter d = 3.0069433
Critical t = 1.7056179
Df = 26
Total sample size = 27
Actual power = 0.9001510
Dropout: Contingency 20% = 32

Outcome variables will be analysed using student T-tests and linear mixed model ANOVA or non-parametric equivalents. Where the linear mixed model ANOVA results are significant, Tukey’s post hoc analysis will be used for comparisons between treatments. Statistical significance will be set at a level of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
21/12/2021
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
32
Accrual to date
13
Final
Recruitment outside Australia
Country [1] 23927 0
New Zealand
State/province [1] 23927 0
Manawatu

Funding & Sponsors
Funding source category [1] 309010 0
Commercial sector/Industry
Name [1] 309010 0
Fonterra Co-operative Group Limited
Country [1] 309010 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group Limited
Address
Fonterra Co-operative Group Limited
Private Bag 11029
Palmerston North 4410
Dairy Farm Road,
Palmerston North
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309945 0
None
Name [1] 309945 0
Address [1] 309945 0
Country [1] 309945 0
Other collaborator category [1] 281893 0
University
Name [1] 281893 0
Massey University
Address [1] 281893 0
Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
New Zealand
Country [1] 281893 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308897 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 308897 0
Private Bag 11 222
Palmerston North 4442
New Zealand
Ethics committee country [1] 308897 0
New Zealand
Date submitted for ethics approval [1] 308897 0
Approval date [1] 308897 0
17/12/2019
Ethics approval number [1] 308897 0
19/73

Summary
Brief summary
32 healthy, fit men aged 18-45 years, with running as one component of their exercise regime will be recruited to receive daily supplementation of probiotics or placebo for 4 weeks. Then the effect on running time trial in the heat will be measured. This is a randomised cross-over design so that men will start either the treatment or placebo in the first phase and then continue with the control or treatment for the second phase of the study, so that all participants complete both phases, but in random order. Mucosal immunity will be determined by IgA in saliva by collection of saliva following the time trial.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 112262 0
A/Prof Toby Mundel
Address 112262 0
School of Sport, Exercise and Nutrition
Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
New Zealand
Country 112262 0
New Zealand
Phone 112262 0
+64 69517538
Fax 112262 0
Email 112262 0
[email protected]
Contact person for public queries
Name 112263 0
A/Prof Toby Mundel
Address 112263 0
School of Sport, Exercise and Nutrition
Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
New Zealand
Country 112263 0
New Zealand
Phone 112263 0
+64 69517538
Fax 112263 0
Email 112263 0
[email protected]
Contact person for scientific queries
Name 112264 0
Dr Jasmine Thomson
Address 112264 0
Fonterra Cooperative Group Limited
Private Bag 11029, Palmerston North, 4410
Dairy Farm Road, Palmerston North, New Zealand
Country 112264 0
New Zealand
Phone 112264 0
+64 6 351 7700
Fax 112264 0
Email 112264 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
Release of clinical trial data may compromise future patents and other intellectual property assets


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.