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Trial registered on ANZCTR


Registration number
ACTRN12620000106932
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
5/02/2020
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy Optimal Australian Microbiome (HOAM) Study
Scientific title
The Healthy Optimal Australian Microbiome (HOAM) Study
Secondary ID [1] 299962 0
NONE
Universal Trial Number (UTN)
Trial acronym
HOAM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity
315407 0
dementia
315408 0
Alzheimer's disease 315409 0
overweight 315410 0
dysbiosis 315411 0
metabolic disease 315412 0
cognitive impairment 315413 0
frailty 315414 0
longevity 315415 0
centenarian 315416 0
optimal health 315417 0
microbiome signature 315418 0
Condition category
Condition code
Metabolic and Endocrine 313705 313705 0 0
Metabolic disorders
Metabolic and Endocrine 313706 313706 0 0
Diabetes
Metabolic and Endocrine 313707 313707 0 0
Normal metabolism and endocrine development and function
Metabolic and Endocrine 313708 313708 0 0
Other metabolic disorders
Alternative and Complementary Medicine 313709 313709 0 0
Other alternative and complementary medicine
Mental Health 313710 313710 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 313711 313711 0 0
Other mental health disorders
Diet and Nutrition 313712 313712 0 0
Obesity
Diet and Nutrition 313713 313713 0 0
Other diet and nutrition disorders
Public Health 313714 313714 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ONE TIMEPOINT SAMPLE ONLY:
- Stool Sample
- Oral Swab Sample
- Blood Sample
- Collection of Vital Sign Measurements / BMI / Biometric Impedance Analysis (BIA) scales
- Participant Demographics & Lifestyle Questionnaire
- K10 Assessment (Depression/Anxiety Scale)
- International Physical Activity Questionnaire (IPAQ)
- Australian Eating Survey - Dietary Assessment
- Grip Strength Assessment (Senior Participants)
- Sit-Stand Assessment (Senior Participants)
- Mini-Mental State Exam (MMSE) / EQ-5D-5L / Lawton and Brody of Daily Living scale / Cumulative illness rating scale / and Mini Nutritional Assessment (Senior Participants)
- Cognitive Battery Test (Optional - Adult Participants)
Intervention code [1] 316227 0
Diagnosis / Prognosis
Comparator / control treatment
Participants aged 19-65 years of age (Adults):
This group will be divided into two subgroups, young adults (aged 19-44) and adults (aged 45-65). For assumed-optimal healthy and active adult subgroups, we perceive that there are a great number of eligible and suitable participants who will be interested in participating and may be recruited from sporting clubs, community groups, gyms or fitness centres. For adult control subgroups, we intend to recruit these participants with support from local clinicians who treat patients who are overweight and obese.

Participants aged 65-94 years of age (Senior Adults), and participants aged 95 years and older (Very senior adults):
Participants within these groups will not be divided into active/healthy and control groups like the other age cohorts; following enrolment and sample analysis, these participants will be categorised based on cognitive scores and these data will be matched with accompanying clinical information.
Senior and very senior adults will be recruited from the community and local public & private geriatric clinical streams, as well as from large, longitudinal studies of ageing.
Control group
Active

Outcomes
Primary outcome [1] 322135 0
The primary outcome measure of this study is to determine the microbial signature of participants belonging to the cross-sectional cohorts in the study design. The microbial signature of participants will be determined using a composite of multi-omics microbiome analysis methods performed on stool, oral and blood samples. Primary analysis techniques to be performed on these biological samples include:
- shotgun metagenomics
- transcriptomics
- metabolomics
- lipidomics
Timepoint [1] 322135 0
At enrolment - single visit/timepoint
Secondary outcome [1] 377449 0
Physical activity status will be assessed using the International Physical Activity Questionnaire (IPAQ).

Timepoint [1] 377449 0
At enrolment - single visit/timepoint
Secondary outcome [2] 379205 0
Dietary status will be assessed using the Australian Eating Survey® which will allow the investigating team to gain insight into a subject's dietary habits over 3-6 months in retrospect via a questionnaire.
Timepoint [2] 379205 0
At enrolment - single visit/timepoint
Secondary outcome [3] 379206 0
Depression and Anxiety scores will be assessed using the K10 Depression & Anxiety Scale test.

Timepoint [3] 379206 0
At enrolment - single visit/timepoint
Secondary outcome [4] 379207 0
General health status will be assessed using collected data about past medical history, Vital Signs, Height / Length, Weight, BMI, Body Composition.
Timepoint [4] 379207 0
At enrolment - single visit/timepoint
Secondary outcome [5] 379208 0
*OPTIONAL* Cognitive status will be assessed using a Cognitive Battery Test.
Only applied to our adult participants in the age range of 19-65 years as an opt-in assessment, this battery of nine cognitive tasks and assessments seeks to assess nine distinct dimensions of cognition. The battery is comprised of the following tests/assessment tools:
- Emotion Decision Gender Task
- Raven’s Advanced Progressive Matrices
- N-Back
- Wisconsin Card Sorting Test
- Ellsberg Urn Task
- Iowa Gambling Task
- Reading the Mind in the Eyes
- Vividness of Visual Imagery Questionnaire
- Object-Spatial Imagery Questionnaire
- Rational-Experiential Inventory

The tasks and assessments all involve reacting to words, letters, shapes, colours or patterns on a screen. None of these tasks and assessments are upsetting, anxiety-provoking or dangerous to participants in any known way. Additionally, none of these tasks and assessments involve deception. All tasks will be performed voluntarily via a computer-based test which must be undertaken onsite at the MRC. This element of the schedule of assessments is strictly only to be offered to adults aged 19-65 and has been designed by co-investigators on this research study.
Undertaking this assessment is optional because of the time commitment attached to it, and any participants who agree to undertake and complete this assessment will receive compensation in the form of a shopping voucher for a small value.
Timepoint [5] 379208 0
At enrolment - single visit/timepoint
Secondary outcome [6] 379209 0
Only applied to the senior and very senior adults: Strength, skeletal muscle health, and malnutrition witll be assessed using a Grip-Strength assessment.
Timepoint [6] 379209 0
At enrolment - single visit/timepoint
Secondary outcome [7] 379210 0
Only applied to the senior and very senior adults: Stability, skeletal muscle strength, and cognition witll be assessed using a Sit/Stand assessment.
Timepoint [7] 379210 0
At enrolment - single visit/timepoint
Secondary outcome [8] 379211 0
Only applied to the senior and very senior adults, mental state and mental health status will be assessed using the Mini-Mental State Exam (MMSE).
Timepoint [8] 379211 0
At enrolment - single visit/timepoint
Secondary outcome [9] 379212 0
Only applied to the senior and very senior adults, quality of life will be assessed using the EQ-5D-5L scoring instrument.
Timepoint [9] 379212 0
At enrolment - single visit/timepoint
Secondary outcome [10] 379213 0
Only applied to the senior and very senior adults, ability to attend to care needs and activities of daily living independently will be assessed using the Lawton and Brody ADL scale.
Timepoint [10] 379213 0
At enrolment - single visit/timepoint
Secondary outcome [11] 379214 0
Only applied to the senior and very senior adults, disease and disability burden will be assessed using the Cumulative Illness Rating Scale.
Timepoint [11] 379214 0
At enrolment - single visit/timepoint
Secondary outcome [12] 379215 0
Only applied to the senior and very senior adults, focused nutritional status will be assessed using the Mini Nutritional assessment.
Timepoint [12] 379215 0
At enrolment - single visit/timepoint

Eligibility
Key inclusion criteria
Active Young Adult:
• Participant is aged between 19-45 years old.
• Participant is able to provide own consent.
• Participant does not require interpretive language services to communicate in English.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant is in good general health.
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant is not undergoing any ongoing medical intervention or tests.
• Participant participates in regular physical activity >3 hours per week.
• Participant has a healthy body weight and is not overweight or obese (BMI between 18.5 – 24.9).
• Participant has no significant past medical history.
• Participant on average gets greater than 7 hours of sleep per night.

Young Adult Control:
• Participant is aged between 19-45 years old.
• Participant does not require interpretive language services to communicate in English.
• Participant is able to provide own consent.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant does not participate in regular physical activity >3 hours per week.
• Participant is overweight or obese (BMI greater than 29; high body fat mass % as per impedance analysis scale).

Active Adult:
• Participant is aged between 46-65 years old.
• Participant is able to provide own consent.
• Participant does not require interpretive language services to communicate in English.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant is in good general health.
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant is not undergoing any ongoing medical intervention or tests.
• Participant participates in regular physical activity >3 hours per week.
• Participant has a healthy body weight and is not overweight or obese (BMI between 18.5 – 24.9).
• Participant has no significant past medical history.
• Participant on average gets greater than 7 hours of sleep per night.

Adult Control:
• Participant is aged between 46-65 years old.
• Participant is able to provide own consent.
• Participant does not require interpretive language services to communicate in English.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant does not participate in regular physical activity >3 hours per week.
• Participant is overweight or obese (BMI greater than 29; high body fat mass % as per impedance analysis scale).

Senior Adult:
• Participant Is aged between 66-94 years old.
• Participant can provide own consent or have consent provided for them legally
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant does not require interpretive language services to communicate in English.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant is willing and able to complete the questionnaire-based and physical assessments in this study.

Very Senior Adult:
• Participant is greater than 95 years old.
• Participant can provide own consent or have consent provided for them legally
• Participant has not taken any antibiotic medication within the past 6 months.
• Participant does not require interpretive language services to communicate in English.
• Participant is willing and able to provide a stool, blood and oral sample for this study.
• Participant is willing and able to complete the questionnaire-based and physical assessments in this study.
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active Young Adult:
• Participant has taken any antibiotic medication within the past 6 months.
• Participant is undergoing ongoing medical intervention or tests.
• Participant suffers from acute or chronic illness of any description.
• Participant requires interpretive language services to communicate in English.
• Participant has a history of disease, cancer, or congenital abnormality.
• Participant is overweight or obese (BMI greater than 24.9).
• Participant does not regularly exercise greater than 3 hours per week.
• Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
• Participant is dependent on medication for an acute or chronic illness, ongoing medical condition or complaint.
• Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
• Participant regularly suffers from chronic or acute pain.
• Participant has diagnosed food allergy or intolerance.
• Participant has experienced recent cause of grief or trauma.
• Participant is pregnant or is within 1-year post-pregnancy.
• Participant is lactating, and/or currently breastfeeding.
• Participant has undergone any major surgery within lifetime (excludes orthopaedic and dental surgery).
• Participant has made a major change to diet in the past month prior to enrolment.
• Participant suffers from chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis).

Young Adult Control:
• Participant is not aged between 19-45 years old.
• Participant is not able to provide own consent.
• Participant has taken any antibiotic medication within the past 6 months.
• Participant does not require interpretive language services to communicate in English.
• Participant is not overweight or obese (BMI less than 28; lean body fat mass % as per impedance analysis scale).
• Participant has undergone major GI surgery such as bowel resection other previous bariatric procedure

Active Adult:
• Participant has taken any antibiotic medication within the past 6 months.
• Participant is undergoing ongoing medical intervention or tests.
• Participant suffers from acute or chronic illness of any description.
• Participant requires interpretive language services to communicate in English.
• Participant has a history of disease, cancer, or congenital abnormality.
• Participant is overweight or obese (BMI greater than 24.9).
• Participant does not regularly exercise greater than 3 hours per week.
• Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
• Participant is dependent on medication for an acute or chronic illness, ongoing medical condition or complaint. Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
• Participant regularly suffers from chronic or acute pain.
• Participant has diagnosed food allergy or intolerance.
• Participant has experienced recent cause of grief or trauma.
• Participant is pregnant or is within 1-year post-pregnancy.
• Participant is lactating, and/or currently breastfeeding.
• Participant has undergone any major surgery within lifetime (excludes orthopaedic and dental surgery).
• Participant has made a major change to diet in the past month prior to enrolment.
• Participant suffers from chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis).

Adult Control:
• Participant is not aged between 46-65 years old.
• Participant is not able to provide own consent.
• Participant has taken any antibiotic medication within the past 6 months.
• Participant does not require interpretive language services to communicate in English.
• Participant is not overweight or obese (BMI less than 28; lean body fat mass % as per impedance analysis scale).
• Participant has undergone major GI surgery such as bowel resection or other previous bariatric procedure


Senior Adult:
• Participant is not aged between 65-94 years of age.
• Participant is unable to provide own consent.
• Participant is unable to complete the assessments, questionnaires and requirements of the study including the provision of a stool and oral sample.
• Participant has undergone major GI surgery such as bowel resection or other previous bariatric procedure.

Very Senior Adult:
• Participant is not aged between 65-94 years of age.
• Participant is unable to provide own consent.
• Participant is unable to complete the assessments, questionnaires and requirements of the study including the provision of a stool and oral sample.
• Participant has undergone major GI surgery such as bowel resection or other previous bariatric procedure.


Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
As the aim of this study is to identify healthy optimal microbial signatures, the age-matched control diseases groups are used to demonstrate the benchmark effect of healthy gut microbiome signatures. The statistical analysis includes comparing microbial a diversity, ß diversity and identifying signatures between healthy and disease groups.
Power calculations for this study were based on published literature. P < 0.05 will be used as a significant finding and unadjusted for the diversity analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15358 0
St George Hospital - Kogarah
Recruitment hospital [2] 15359 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 28674 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 304424 0
Government body
Name [1] 304424 0
Medical Research Futures Fund
Address [1] 304424 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 304424 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW) Sydney
Address
Microbiome Research Centre
St George and Sutherland Clinical School, UNSW Sydney
Level 2, Clinical Sciences Building (WR Pitney), Short Street, St George Hospital, KOGARAH NSW 2217
Country
Australia
Secondary sponsor category [1] 304682 0
None
Name [1] 304682 0
Address [1] 304682 0
Country [1] 304682 0
Other collaborator category [1] 281080 0
Other Collaborative groups
Name [1] 281080 0
Centre for Healthy Brain Ageing (CHeBA)
Address [1] 281080 0
Centre for Healthy Brain Ageing (CHeBA)
School of Psychiatry
Level 1, AGSM (G27)
Gate 11, Botany Street
UNSW SYDNEY NSW 2052
T +61 (2) 9385 7357
Country [1] 281080 0
Australia
Other collaborator category [2] 281081 0
Other Collaborative groups
Name [2] 281081 0
FutureMinds Lab - UNSW
Address [2] 281081 0
Lvl 16 Mathews Building School of Psychology University of New South Wales (UNSW), Sydney NSW 2052
Country [2] 281081 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304860 0
South Eastern Sydney Local Health District (SESLHD) HREC
Ethics committee address [1] 304860 0
Research Support Office
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
Ethics committee country [1] 304860 0
Australia
Date submitted for ethics approval [1] 304860 0
13/09/2019
Approval date [1] 304860 0
27/11/2019
Ethics approval number [1] 304860 0
2019/ETH13001

Summary
Brief summary
Researchers at the Microbiome Research Centre, UNSW Sydney are inviting healthy and active adults to join in a study to help them discover what is the optimal human microbiome-state. The microbiome is the population of microbes occupying various sites on our bodies, and is already known to have a major impact on human health. If we can determine what the normal microbiome of a the supremely healthy person is made up of, then we have the potential to positively change health outcomes for many future generations by using the microbiome as a target for clinical therapies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98434 0
Prof Emad El-Omar
Address 98434 0
Microbiome Research Centre
St George and Sutherland Clinical School
University of New South Wales
Level 2 Clinical Sciences (WR Pitney) Building
St George Hospital
Short Street, Kogarah
Sydney, NSW 2217
Country 98434 0
Australia
Phone 98434 0
+61 02 9113 2011
Fax 98434 0
Email 98434 0
e.el-omar@unsw.edu.au
Contact person for public queries
Name 98435 0
Ms Isabelle Ibrahim
Address 98435 0
Microbiome Research Centre
St George and Sutherland Clinical School, UNSW Sydney
Level 2, Clinical Sciences Building (WR Pitney), Short Street, St George Hospital, KOGARAH NSW 2217

Country 98435 0
Australia
Phone 98435 0
+61 02 9113 1117
Fax 98435 0
Email 98435 0
i.ibrahim@unsw.edu.au
Contact person for scientific queries
Name 98436 0
Ms Isabelle Ibrahim
Address 98436 0
Microbiome Research Centre
St George and Sutherland Clinical School, UNSW Sydney
Level 2, Clinical Sciences Building (WR Pitney), Short Street, St George Hospital, KOGARAH NSW 2217

Country 98436 0
Australia
Phone 98436 0
+61 02 9113 1117
Fax 98436 0
Email 98436 0
i.ibrahim@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
- Microbial Signature Data
- Various accompanying Metadata
- Composite information related to health and lifestyle
When will data be available (start and end dates)?
At completion of analysis - No end date determined
Available to whom?
Researchers and Clinicians - Available upon Request
Available for what types of analyses?
- Computational Research Purposes
- Epidemiological Studies
- Other Relevant Analyses
How or where can data be obtained?
Please contact the PI to make a request for information related to this study. Email contact can be made by contacting Professor Emad El-Omar on e.el-omar@unsw.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results