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Trial registered on ANZCTR


Registration number
ACTRN12617001620314
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
11/12/2017
Date last updated
21/10/2019
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of resistance training on the human gut microbiota.
Scientific title
The effect of resistance exercise training on the composition and diversity of the human gut microbiota in healthy sedentary individuals.
Secondary ID [1] 293440 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut Microbiota 305615 0
Condition category
Condition code
Oral and Gastrointestinal 304838 304838 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Intervention

Participants randomised to the intervention group will complete a 12-week supervised resistance exercise training program prescribed three times per week on non-consecutive days. Each session will last approximately 60 minutes and consist of either one-on-one or group training with multiple participants (2–5) per trainer. The exercise prescription will be split into two 6-week programs progressing from machine-based prescription to free weight-style prescription. Following 5-10 minutes of light intensity warm-up, participants will complete 7-8 exercises targeting all the major muscle groups of the body. Three sets of 8-10 repetitions will be performed of each exercise prior to moving on to the following exercise. Sets will be performed to the point of concentric muscular fatigue, with the load being adjusted for each exercise to ensure fatigue is achieved in the target repetition range. Exercises will be substituted when deemed necessary due to musculoskeletal limitations. Participants will keep an exercise diary (completed at the supervised sessions) to monitor adherence to and progression of their programs. Intervention group participants will be instructed to refrain from performing any additional resistance-type or aerobic training for the duration of the study.

A qualified exercise physiologist (Mr Alan Ezzy) will supervise all routines. Mr Ezzy holds a Bachelor of Exercise and Sports Science (Clinical Exercise Physiology) - 1st Class Honours from the University of New England. Mr Ezzy also has 12 months recent experience (2016) practicing as a clinical exercise physiologist. The intervention will take placein the exercise physiology laboratory on-campus at the University of New England, Armidale, NSW Australia.

Intervention code [1] 299684 0
Lifestyle
Comparator / control treatment
Control group participants will be advised not to change habitual activity levels (sedentary). Control participants will received no specific instructions regarding physical activity or access to equipment during the initial 12-week intervention period or weeks 13-16 time period. Control participants will be contacted via email on a fortnightly basis to ensure adherence to the program.
Control group
Active

Outcomes
Primary outcome [1] 304043 0
Evaluate the effect of 12 weeks resistance exercise training on the composition of gut microbiota assessed from stool samples. DNA from gut microbiota will be extracted, sequenced and identified. The composition of the gut microbiota will be assessed at a number of taxonomic levels (species, genus, family, phylum). Significant changes/differences in gut microbiota composition will be assessed within group (across sampling time-points) and between groups (at comparative sampling time-points).
Timepoint [1] 304043 0
Participants will be asked to provide multiple stool samples in the 3-7 days prior to intervention (weeks 0), during intervention (weeks 4 & 8), 3-7 days post intervention & 4 weeks post intervention.
Primary outcome [2] 304044 0
Evaluate the effect of 12 weeks resistance exercise training on gut microbiota diversity assessed from stool samples. DNA from gut microbiota will be extracted, sequenced and identified. The mean number of species indicates the diversity of the gut microbiota. Gut microbiota diversity will be assessed within group (across sampling time-points) and between groups (at comparative sampling time-points).
Timepoint [2] 304044 0
Participants will be asked to provide multiple stool samples in the 3-7 days prior to intervention (weeks 0), during intervention (weeks 4 & 8), 3-7 days post intervention & 4 weeks post intervention.
Secondary outcome [1] 340780 0
To evaluate the effect of 12 weeks resistance exercise training on the abundance of faecal SCFAs. This will be assessed through gas chromatography liquid spectroscopy.
Timepoint [1] 340780 0
Participants will be asked to provide multiple stool samples in the 3-7 days prior to intervention (weeks 0), during intervention (weeks 4 & 8), 3-7 days post intervention & 4 weeks post intervention.
Secondary outcome [2] 340801 0
Mental health: Depression assessed with PHQ-9 scale..
Timepoint [2] 340801 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [3] 340802 0
Mental health: Anxiety assessed with GAD-7 scale.
Timepoint [3] 340802 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [4] 340803 0
Diet: Daily energy intake (including macronutrient contribution to daily energy - carbohydrate, protein, fat) will be quantified through an online food diary (myfitnesspal.com). Participants will complete the diary for 3 consecutive days prior to faecal sample collection.
Timepoint [4] 340803 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [5] 341053 0
Anthropometry: Height will be measured with a wall mounted stadiometer
Timepoint [5] 341053 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [6] 341054 0
Anthropometry: Mass will measured using digital scales.
Timepoint [6] 341054 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [7] 341055 0
Anthropometry: Upper limb muscle thickness (elbow flexors) will be assessed through ultrasonography.
Timepoint [7] 341055 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [8] 341056 0
Anthropometry: Lower limb muscle thickness (knee extensors) will be assessed through ultrasonography.
Timepoint [8] 341056 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [9] 341057 0
Muscular strength. Upper body muscular strength will be assessed via a 1 repetition maximum bench press protocol.
Timepoint [9] 341057 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [10] 341058 0
Muscular strength. Upper limb muscular strength will be assessed via a 1 repetition maximum bilateral arm curl protocol.
Timepoint [10] 341058 0
Weeks 0, 4, 8, 13 and 16
Secondary outcome [11] 341059 0
Muscular strength. Lower limb muscular strength will be assessed via a 1 repetition maximum leg press protocol.
Timepoint [11] 341059 0
Weeks 0, 4, 8, 13 and 16

Eligibility
Key inclusion criteria
Healthy, normal - high body mass index (BMI between (greater or equal to) 18.5 and (less than) 30.0 kg/m^2), currently sedentary (<150 min of structured exercise per week, no current resistance training).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to provide informed consent
Any previous or current chronic health conditions
Any musculoskeletal injury which may affect ability to perform resistance exercise
Any previous or current gastro-intestinal or immune pathologies (including gastrointestinal surgery)
History of chronic alcohol consumption
Chronic habitual smoking within the last 6 months
History of mental health conditions or illness within the last 6 months
Oral antibiotics use within the last 6 months
Chronic non-steroidal anti-inflammatory use within the last 6 months
Have taken any probiotic supplement or supplements to improve gut health within the last 6 months
Any regular structured aerobic or resistance-based exercise (>150 min per week) within the last 6 months.
Pregnancy or lactation

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a computer-generated list. To ensure groups are not biased by body mass index (BMI), a potentially confounding variable, participants will be stratified by normal and overweight categories (18.5-24.9 kg/m^2; 25-29.9 kg/m^2) before being randomly assigned. Allocation rate to intervention and control groups will be set at 2:1 respectively
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There has not been any previous study investigating the impact of resistance exercise training on the human gut microbiota. As such, the expected effect size is not known. However, previous research into antibiotic exposure reveals changes in microbial diversity similar to that observed in cross-sectional exercise data comparing athletes and non-athletes (Clarke et al., 2014).

Based on antibiotic exposure (Jaccard distance): 5 subjects per group allows 90% power to detect a omega squared of 0.05; 10 subjects per group allows 90% power to detect an omega squared of 0.02; and 20 subjects per group allows 90% power to detect an omega squared of 0.008. Therefore 10 participants per group should allow us to 90% power to detect a small to moderate effect.

A power calculation has also been performed for resistance training metrics. Setting the alpha at 0.05 and beta at 0.20, a minimum of 10 participants were required per treatment group to detect a large effect (ES=0.8). This study plans to recruit 38 participants to account for the 2:1 allocation and 20% drop-out rate. This research is a pilot study into this area.

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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2018
Actual
8/01/2018
Date of last participant enrolment
Anticipated
8/03/2019
Actual
16/04/2019
Date of last data collection
Anticipated
31/07/2019
Actual
20/08/2019
Sample size
Target
38
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 18142 0
2350 - Armidale
Recruitment postcode(s) [2] 18143 0
2351 - University Of New England

Funding & Sponsors
Funding source category [1] 298069 0
University
Name [1] 298069 0
University of New England
Country [1] 298069 0
Australia
Primary sponsor type
University
Name
University of New England
Address
University of New England
School of Science and Technology
Armidale NSW
2351
Country
Australia
Secondary sponsor category [1] 297146 0
Individual
Name [1] 297146 0
Dr. Amanda Hagstrom
Address [1] 297146 0
University of New England
School of Science and Technology
Armidale NSW
2351
Country [1] 297146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299085 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 299085 0
Ethics committee country [1] 299085 0
Australia
Date submitted for ethics approval [1] 299085 0
03/10/2017
Approval date [1] 299085 0
20/10/2017
Ethics approval number [1] 299085 0
HE17-236

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

Contacts
Principal investigator
Name 79250 0
Dr Amanda Hagstrom
Address 79250 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 79250 0
Australia
Phone 79250 0
+61 2 6773 3166
Fax 79250 0
Email 79250 0
ahagstro@une.edu.au
Contact person for public queries
Name 79251 0
Alan Ezzy
Address 79251 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 79251 0
Australia
Phone 79251 0
+61 2 6773 1924
Fax 79251 0
Email 79251 0
aezzy@myune.edu.au
Contact person for scientific queries
Name 79252 0
Amanda Hagstrom
Address 79252 0
School of Science and Technology
University of New England
Armidale NSW 2351
Country 79252 0
Australia
Phone 79252 0
+61 2 6773 3166
Fax 79252 0
Email 79252 0
ahagstro@une.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be presented as group averages to maintain anonymity among participants.


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.