Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000164190
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
5/02/2019
Date last updated
7/10/2021
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Microbiome in Active and Sedentary Older People (MASOP) Study
Scientific title
Microbiome in Active and Sedentary Older People
Secondary ID [1] 297186 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
MASOP
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Cognition 311230 0
Gut health 311231 0
Body composition 311257 0
Condition category
Condition code
Oral and Gastrointestinal 309856 309856 0 0
Normal oral and gastrointestinal development and function
Neurological 309857 309857 0 0
Studies of the normal brain and nervous system
Diet and Nutrition 309858 309858 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To conduct a pilot study to develop an integrated framework for elucidating a deeper understanding of the relationship between gut health, body composition and cognitive function in free-living sedentary and active elderly populations to optimise personalised lifestyle interventions in Singapore and Australia.

Participants will attend two clinic visits to CSIRO and one visit to Dr Jones and partners for an MRI. All three visits will be conducted within a two week period. The two clinic visits will be separated by one week. The MRI will be within one week of the second clinic visit.

The first clinic visit is a screening visit:
Once the participants are deemed eligible for the study through phone screen and satisfaction of inclusion and exclusion criteria, they will be invited to our research clinic for a more detailed screening session. This initial appointment will take approximately 90 minutes and will allow the subjects to hear more about the study purpose and how it will be conducted as well as their commitments and any risks or discomforts associated with the study. If they then decide to proceed they will:

• sign a consent form for participation in the study
• have their height and weight measured
• confirm details about their medical history, surgical history and medications
• have their vital signs checked by a nurse (blood pressure, heart rate, temperature and respiratory rate).
• Undertake the Geriatric depression scale and Edmonton Frail scale.
• undertake two short cognitive tests (MOCA and C-CAB)
• be provided with a faecal collection kit and full instructions for sampling
• be provided with 3-day weighed diet diary equipment and instructions
• be provided with a pack of surveys and questionnaires

Subjects will then take these items home and three days prior to the next clinic visit they will start a 3-day weighed food diary. Within 24h prior to the next visit to the clinic they will be asked to produce a faecal sample at home and store in the supplied cooler pack. They will then bring all questionnaires, diet diary equipment and the faecal sample to the next clinic visit which will take approximately three hours. They will also be asked to fast overnight (water only) prior to the clinic visit. Participants will be sent an SMS reminder of their appointment time and to fast the day before their clinic visit. We will check on arrival if the particpant has fasted and from what time and record it in the CRF. The clinic visit involves:

• returning completed questionnaires and handing in their faecal sample
• having their weight measured again
• having their vital signs check by a nurse (blood pressure, heart rate, temperature and respiratory rate).
• providing a fasting (water only) blood sample
• consuming a sugar drink and providing another blood sample 90 minutes later
• providing a urine and saliva/buccal cell sample
• discussing their diet diary with a trained dietitian
• completing a food frequency questionnaire
• dual-energy X-ray absorptiometry (DXA) body imaging
• breakfast
• Grip strength test
• Short physical performance test
• completing one short cognitive test for the second time (C-CAB)

They will then be asked to attend one Magnetic Resonance Imaging (MRI) session at Dr Jones and Partners which is also located at the SAHMRI research centre. This appointment will take approximately 30 minutes and will take structural images of the brain. These three visits will be conducted over a two week period.
Intervention code [1] 313462 0
Not applicable
Comparator / control treatment
The two groups that are being compared are:
Free-living sedentary elderly males and females (65-80 years)
Free-living active elderly males and females (65-80 years)

Sedentary is being defined by a score of equal to or less than 200 METs/week, and active is being defined by a score of equal to or greater than 1000 METs/week, as assessed using the Global Physical Activity Questionnaire (GPAQ)
Control group
Active

Outcomes
Primary outcome [1] 318826 0
Short chain fatty acids as assessed by GC-MS analysis of stool sample.
Timepoint [1] 318826 0
Stool sample collected within 24 hours of the second clinic visit
Secondary outcome [1] 366167 0
Cognition and wellbeing (a composite secondary outcome) assessed using the following tools/ questionnaires:
- Montreal Cognitive Assessment (MOCA)
- Computerised Cognitive Assessment Battery (C-CAB)
- Mental Health Continuum-Short Form (MHC-SF)
- Scale of Positive and Negative Affect (SPANE)
- Short Warwick-Edinburgh mental Well-being Scale (SWEMWBS)
- Geriatric depression scale (short form)
- DASS-21 (Depression, Anxiety and Stress Scale)
Timepoint [1] 366167 0
Below outlines when each tool/ questionnaire will occur:

Screening visit (clinc visit no. 1)
- Montreal Cognitive Assessment (MOCA)
- Computerised Cognitive Assessment Battery (C-CAB)
- Geriatric depression scale (short form)

Questionnaires completed at home and returned at the second clinic visit:
- Mental Health Continuum-Short Form (MHC-SF)
- Scale of Positive and Negative Affect (SPANE)
- Short Warwick-Edinburgh mental Well-being Scale (SWEMWBS)
- DASS-21 (Depression, Anxiety and Stress Scale)

Clinic visit no. 2
- Computerised Cognitive Assessment Battery (C-CAB) (conducted for the second time)
Secondary outcome [2] 366168 0
Gut Permeability
-The gut permeability blood samples will be tested in-house for sugar concentrations using HPLC with Amphoteric Electrochemical Detection.
Timepoint [2] 366168 0
Clinic visit no. 2
Secondary outcome [3] 366170 0
Body composition assessed using a Dual X-ray Absorptiometry (DXA)
Timepoint [3] 366170 0
Clinic visit no. 2
Secondary outcome [4] 366171 0
Structural information of brain including volume, information on grey/white matter composition, brain iron estimations and blood-brain barrier structure all assessed by an
MRI (composite secondary outcome)
Timepoint [4] 366171 0
to be booked within one week of the second clinic visit (before or after)
Secondary outcome [5] 366173 0
Usual dietary intake measured using a 3-day weighed food diary and food frequency questionnaire.
Timepoint [5] 366173 0
3 days prior to the second clinic visit
Secondary outcome [6] 366174 0
Physical function assessed by undertaking the Short Physical Performance Battery and Grip strength test.
Timepoint [6] 366174 0
Clinic visit no. 2
Secondary outcome [7] 366175 0
Gastrointestinal symptoms & comfort using the 'Gastrointestinal Symptom Rating Scale'
Timepoint [7] 366175 0
To be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [8] 366178 0
Amount of physical activity undertaken
CHAMPS (Community Healthy Activities Model Program for Seniors)
Timepoint [8] 366178 0
To be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [9] 366179 0
Measure of frailty
Edmonton Frail Scale
Timepoint [9] 366179 0
Edmonton Frail Scale is to be completed at the screening clinic visit (visit no. 1)

Measure of frailty is to be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [10] 366180 0
Level of appetite
CNAQ (Council on Nutrition Appetite Questionnaire)
Timepoint [10] 366180 0
To be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [11] 366181 0
Sleep quality
PSQI (Pittsburgh Sleep Quality Index)
Timepoint [11] 366181 0
To be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [12] 366182 0
Physical activity readiness
PAR-Q+ (Physical Activity Readiness Questionnaire)
Timepoint [12] 366182 0
To be completed at home between the first and second clinic visit (which will be one week apart)
Secondary outcome [13] 366183 0
Fasting Blood Glucose- blood test
Timepoint [13] 366183 0
At second clinic visit
Secondary outcome [14] 366187 0
CRP (C reactive protein)- blood test
Timepoint [14] 366187 0
At second clinic visit
Secondary outcome [15] 366190 0
Lipid studies (HDL, triglycerides)- blood test (composite secondary outcome)
Timepoint [15] 366190 0
At second clinic visit
Secondary outcome [16] 366191 0
Liver Function- blood test
Timepoint [16] 366191 0
At second clinic visit
Secondary outcome [17] 366192 0
ESR (erythrocyte sedimentation rate) via blood assay
Timepoint [17] 366192 0
At second clinic visit
Secondary outcome [18] 366193 0
Plasma metabolomics subjected to metabolic profiling analysis by ultra-performance liquid chromatography-mass spectrometry (UPLC-MS)
Timepoint [18] 366193 0
At second clinic visit

Eligibility
Key inclusion criteria
- Male or female individuals
- Aged 65 years to 80 years of age, inclusive
- BMI 20 to 30 kg/m2, inclusive
- Understand the study requirements, willing and able to undertake all study assessments over three separate visits and provide written informed consent
- Score equal to or greater than 26 on the Montreal Cognitive Assessment
- Score of either sedentary (equal to or less than 200 METs/week) or active (equal to or greater than 1000 METs/week) as assessed using the Global Physical Activity Questionnaire (GPAQ)
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of smoking within the last 6 months
- Living in a care facility or retirement home that has communally prepared meals
- Surgical history that in the opinion of the Principal Investigator could modulate gut function (e.g. - gastric bypass, colectomy etc.)
- Use of medication/nutraceuticals within the last 3 months that in the opinion of the Principal Investigator may interfere with colonic microbiome composition (e.g. – antibiotics, steroids, laxatives, fibre supplements, probiotic/prebiotic supplements etc.)
- Self-reported history of diabetes, gastrointestinal, renal, hepatic disease or intestinal inflammation, including inflammatory bowel disease (Crohn’s disease and ulcerative colitis), coeliac disease, short bowel syndrome, irritable bowel syndrome, chronic constipation or regular bouts of diarrhoea, cancer or stroke, within the last 5 years
- Self-reported psychological/psychiatric disorder (e.g. depression, anxiety etc.) that in the opinion of a Psychologist might impact the participant’s ability to undertake study measurements
- Self-reported history of claustrophobia
- Presence of any ferrous metal in the body
- Self-reported alcohol consumption of equal to or greater than 14 standard drinks per week
- Self-reported participation in a study with any experimental drug/supplement within the 30 days prior to commencement of the study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
SAMPLE SIZE
The effect of exercise on the gut microbiome is the focus of the study, but is also quite a new concept with few studies already published. However, the main effect of exercise is an increase in bacterial phylogenetic alpha diversity and this is our primary endpoint. A previous study in this area has shown that in an adult population, the mean alpha diversity measure (Faith’s phylogenetic-dependent method) of their faecal microbiota was 47.5 ± 10.75. However, our older cohort will have a lower alpha diversity, which is common in elderly individuals. Therefore, in order to detect a difference of moderate magnitude (Cohen’s d=.70) we require a sample size of n = 43 per group type I error of 0.05 and power of .90. Therefore, n = 50 per group (physically active and inactive) will be enough to achieve statistical power recruited to allow for any participant withdrawals.

STATISTICAL METHOD TO EVALUATE DATA
Statistical effects will be assessed using a combination of regression, multivariate and correlational analyses. Statistical analyses will be performed using R version 3.5. All statistical tests will be performed at a significance level of =0.05 (after fdr correction).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2019
Actual
23/05/2019
Date of last participant enrolment
Anticipated
24/06/2019
Actual
20/12/2019
Date of last data collection
Anticipated
26/07/2019
Actual
24/12/2019
Sample size
Target
100
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301738 0
University
Name [1] 301738 0
Nanyang Technological University
Country [1] 301738 0
Singapore
Funding source category [2] 301779 0
Government body
Name [2] 301779 0
CSIRO- Precision Health Future Science Platform
Country [2] 301779 0
Australia
Primary sponsor type
Government body
Name
CSIRO Health and Biosecurity
Address
PO Box 10041
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 301478 0
University
Name [1] 301478 0
Nanyang Technological University
Address [1] 301478 0
50 Nanyang Ave, Singapore 639798
Country [1] 301478 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302462 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 302462 0
Ethics committee country [1] 302462 0
Australia
Date submitted for ethics approval [1] 302462 0
07/12/2018
Approval date [1] 302462 0
12/12/2018
Ethics approval number [1] 302462 0
12/2018

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

Contacts
Principal investigator
Name 90302 0
Prof Lynne Cobiac
Address 90302 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA 5000
Country 90302 0
Australia
Phone 90302 0
+61 8 8303 8855
Fax 90302 0
Email 90302 0
[email protected]
Contact person for public queries
Name 90303 0
Nathan O'Callaghan
Address 90303 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA 5000
Country 90303 0
Australia
Phone 90303 0
+61 8 8303 8867
Fax 90303 0
Email 90303 0
Nathan.O'[email protected]
Contact person for scientific queries
Name 90304 0
Nathan O'Callaghan
Address 90304 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA 5000
Country 90304 0
Australia
Phone 90304 0
+61 8 8303 8867
Fax 90304 0
Email 90304 0
Nathan.O'[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
Undecided


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.