Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000472370
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
31/03/2017
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Date results provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of high intensity exercise training on gut microbiota in humans
Scientific title
The effect of high intensity exercise training on gut microbiota in healthy adult male volunteers
Secondary ID [1] 291555 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut Microbiota 302652 0
Condition category
Condition code
Oral and Gastrointestinal 302167 302167 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of be an initial visit to the laboratory at the University of Auckland Grafton campus to screen participants, gain their informed consent, record anthropometrics and body composition, prior to undergoing a cardiorespiratory fitness to estimate VO2max. This information will be used to tailor the intensity of the exercise-training visits. Participants will also be asked to give a oral swab and a blood sample and fill in a food frequency questionnaire. This visit is scheduled to take a maximum of 2 hours.
There will be nine high intensity exercise training visits over a period of 3 weeks with each visit being separated by at least 1 day of rest. Each training session is scheduled to be a maximum of 45 mins long including warm up and cool down periods. The intervention will be delivered by a masters student at either the Health and Performance Clinic at University of Auckland Tamaki campus or the laboratory at the Grafton Campus (the same venue as the first visit) depending on the preference of the participant. The masters student is an experienced athlete who has participated in stationary cycle training for 25 years and supervised training sessions throughout that period. The student investigator also holds a St Johns first aid certificate.
During these visits, after a short warm up participants will be asked to complete 8-12 repetitions of 60 seconds high intensity cycling on a stationary bike with 75 seconds rest between each repetition. The intensity of the repetition will be between 80-100% of peak power as measured by the VO2 max test. A short recovery "cool down" period will conclude the exercise session. The masters student investigator will brief the each participant and demonstrate the operation of the stationary cycle prior to the first exercise session. The first block of 3 exercise sessions will consist of 8 high intensity intervals, the second and third blocks of 3 sessions consisting of 10 and 12 high intensity intervals respectively.
The final visit of the intervention will be repeat the anthropometrics, body composition, VO2 max test, and blood sample at the Grafton campus as per the first visit. This visit is scheduled to take no more than 75mins (one and a quarter hours).
Participants will be asked to provide 2 stool samples and 2 oral swab samples using the self collection kits provided between visits 1 and 2 and again between visits 10 and 11.
The intervention will be administered face to face (except self sample collection as detailed above).
Participants can attend the intervention individually, however, it will be possible for participants to undergo the exercise training in a small group (5 people or less) if they prefer.
The student investigator will assess adherence to the intervention by recording participant attendance. Fidelity will be assessed by the student investigator supervising the exercise tests and training directly and downloading power output information from the stationary bike after each visit.
Intervention code [1] 297619 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301598 0
To evaluate the effect of multiple sessions of high intensity exercise training on the composition of gut microbiota assessed from stool samples. Participants will be supplied the necessary stool collection kits at the end of visit 1.
DNA from gut microbiome will be extracted using commercially available purification kits, prior to being sequenced and identified. The composition of the gut microbiome will be assessed and significant changes in the proportion of specific species, family and phyla pre and post intervention identified.
Timepoint [1] 301598 0
The composition of gut microbiota will be assessed from stool samples taken at baseline (3-7 days after visit 1) and post intervention (3-7 days after the final high intensity exercise training session at visit 10).
Primary outcome [2] 301632 0
To evaluate the effect of multiple sessions of high intensity exercise training on the diversity of gut microbiota assessed from stool samples. Participants will be supplied the necessary stool collection kits at the end of visit 1.
DNA from gut microbiome will be extracted using commercially available purification kits, prior to being sequenced and identified. .The mean number of species indicates the diversity of the gut microbiome.
Timepoint [2] 301632 0
The diversity of gut microbiota will be assessed from stool samples taken at baseline (3-7 days after visit 1) and post intervention (3-7 days after the final high intensity exercise training session at visit 10).
Secondary outcome [1] 333266 0
To determine the effect of multiple sessions of high intensity exercise training on cardiorespiratory fitness (as measured by VO2max test)
Timepoint [1] 333266 0
Cardiorespiratory fitness will be assessed at baseline during visit 1 and post intervention at visit 11.
Secondary outcome [2] 333267 0
To evaluate the effect of multiple sessions of high intensity exercise training on oral / buccal microbiome assessed from oral swab samples. DNA from oral buccal microbiome will be extracted from the swab using commercially available purification kits, prior to being sequenced and identified. .The mean number of species indicates the diversity of the oral buccal microbiome.
Timepoint [2] 333267 0
The diversity of gut microbiota will be assessed from oral swab samples taken at baseline (at visit 1, and also 3-7 days after visit 1) and post intervention (3-7 days after the final high intensity exercise training session at visit 10).
Secondary outcome [3] 333268 0
To evaluate the effect of multiple sessions of high intensity interval training on blood biomarkers which can be used to assess metabolic health and inflammatory response. This is an exploratory outcome.
Timepoint [3] 333268 0
Blood biomarkers will be assessed from blood samples taken at baseline during visit 1 and post intervention at visit 11.

Eligibility
Key inclusion criteria
Healthy males, lean subjects with BMI <25 and overweight subjects BMI >28. Sedentary to moderately active (less than 4 hours of structured activity per week)
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any previous or current chronic health conditions
Diabetes
Any previous or current gastro-intestinal or immune health conditions
History of alcohol abuse
Smoking
Taking medications which may affect exercise responses
Have taken antibiotics or non-steroidal anti-inflammatory drugs within the previous 2 months
Any musculoskeletal injury which may affect ability to perform cycling exercise
Have taken any probiotic supplement or supplement to improve gut health within the last 2 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 20 participants (10 in each group, lean and overweight) will be necessary to achieve statistical significance of the primary objective. This is based on a single study of previous research on humans - Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, et al. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014;63(12):1913-20. Our research intervention is a pilot study into this area.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2017
Actual
21/04/2017
Date of last participant enrolment
Anticipated
1/04/2020
Actual
11/09/2018
Date of last data collection
Anticipated
1/05/2020
Actual
12/10/2018
Sample size
Target
32
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 8770 0
New Zealand
State/province [1] 8770 0
Auckland

Funding & Sponsors
Funding source category [1] 296046 0
University
Name [1] 296046 0
University of Auckland
Country [1] 296046 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Troy Merry
Address
Department of Molecular Medicine and Pathology
University of Auckland,
Grafton Campus,
85 Park Road,
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 294937 0
None
Name [1] 294937 0
Address [1] 294937 0
Country [1] 294937 0
Other collaborator category [1] 279509 0
Individual
Name [1] 279509 0
Dr. Cherie Blenkiron
Address [1] 279509 0
Department of Molecular Medicine and Pathology / School of Biological Sciences
The University of Auckland,
Grafton Campus,
85 Park Road,
Auckland, 1023
Country [1] 279509 0
New Zealand
Other collaborator category [2] 279510 0
Individual
Name [2] 279510 0
Dr. Nicholas Gant
Address [2] 279510 0
Department of Exercise Sciences
The University of Auckland ,
Tamaki Campus,
261 Morrin Road,
Auckland, 1072
Country [2] 279510 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297302 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 297302 0
Ethics committee country [1] 297302 0
New Zealand
Date submitted for ethics approval [1] 297302 0
08/03/2017
Approval date [1] 297302 0
24/03/2017
Ethics approval number [1] 297302 0
17/STH/42

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1608 1608 0 0
/AnzctrAttachments/372645-HDEC Letter - 17STH42 - Approved Application with non-standard conditions.pdf (Ethics approval)
Attachments [2] 1609 1609 0 0
/AnzctrAttachments/372645-PIS_gutmicrobiota_HDEC_R1 Final Version 27 March.pdf (Participant information/consent)
Attachments [3] 1610 1610 0 0
/AnzctrAttachments/372645-Gutmicrobiota_HDEC_protocol.docx (Protocol)
Attachments [4] 1611 1611 0 0
/AnzctrAttachments/372645-Microbiota_HDEC_poster.pdf (Supplementary information)

Contacts
Principal investigator
Name 73638 0
Dr Troy Merry
Address 73638 0
Department of Molecular Medicine and Pathology,
University of Auckland,
85, Park Road,
Grafton,
Auckland, 1023.
Country 73638 0
New Zealand
Phone 73638 0
+64 9 9239008
Fax 73638 0
Email 73638 0
[email protected]
Contact person for public queries
Name 73639 0
Troy Merry
Address 73639 0
Department of Molecular Medicine and Pathology,
University of Auckland,
85, Park Road,
Grafton,
Auckland, 1023.
Country 73639 0
New Zealand
Phone 73639 0
+64 9 9239008
Fax 73639 0
Email 73639 0
[email protected]
Contact person for scientific queries
Name 73640 0
Troy Merry
Address 73640 0
Department of Molecular Medicine and Pathology,
University of Auckland,
85, Park Road,
Grafton,
Auckland, 1023.
Country 73640 0
New Zealand
Phone 73640 0
+64 9 9239008
Fax 73640 0
Email 73640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbaseShort-term high-intensity interval training exercise does not affect gut bacterial community diversity or composition of lean and overweight men.2020https://dx.doi.org/10.1113/EP088744
N.B. These documents automatically identified may not have been verified by the study sponsor.