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
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
Trial website
Trial related presentations / publications
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
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
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.