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Trial registered on ANZCTR


Registration number
ACTRN12622000535774
Ethics application status
Approved
Date submitted
13/03/2022
Date registered
5/04/2022
Date last updated
7/03/2023
Date data sharing statement initially provided
5/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
High fermentable fibre bread consumption and the bowel health of Australian parents and caregivers of children.
Scientific title
Effect of highly fermentable fibre bread consumption on faecal short chain fatty acid producing bacteria in Australian parents and caregivers of children.
Secondary ID [1] 306676 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor gut health 325615 0
Low fibre consumption 325901 0
Condition category
Condition code
Diet and Nutrition 322972 322972 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 323210 323210 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume 3 slices of bread high in fermentable fibre containing a blend of high fibre grains that include BARLEYmax (providing a total of ~17 g fibre) daily, for 2 weeks. The bread will be delivered to the participant’s home. Participants will complete a daily log via a mobile app or paper-based diary to assess protocol compliance, adverse events and use of concomitant medications. Participants will have a 4 week washout period between intervention/control where they will be advised to continue their regular diet.
Intervention code [1] 323116 0
Treatment: Other
Comparator / control treatment
Participants will consume 3 slices of white bread daily for 2 weeks. The Control bread is low in fibre, providing a total daily dose of ~3 g of dietary fibre..
Control group
Active

Outcomes
Primary outcome [1] 330741 0
short chain fatty acid producing bacteria (%relative abundance) assessed using a stool sample
Timepoint [1] 330741 0
Baseline, 2 weeks post-intervention commencement
Secondary outcome [1] 407391 0
Stool consistency assessed using the Bristol stool rating chart (no units)
Timepoint [1] 407391 0
Baseline, 2 weeks post-intervention commencement
Secondary outcome [2] 407392 0
Gut comfort assessed using the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire (no units)
Timepoint [2] 407392 0
Baseline, 2 weeks post-intervention commencement
Secondary outcome [3] 408267 0
Firmicutes/Bacteroidetes ratio assessed in stool samples
Timepoint [3] 408267 0
Baseline, 2 weeks post-intervention commencement
Secondary outcome [4] 408268 0
Microbial diversity assessed in stool samples
Timepoint [4] 408268 0
Baseline, 2 weeks post-intervention commencement

Eligibility
Key inclusion criteria
1. Male or Female individuals
2. Aged 22 to 55 years of age at clinic screen
3. Be a parent or carer for at least one, primary school aged child aged 5 to 12 years
4. BMI 18.5 to 29.9 at time of clinic screening
5. Willing to maintain body weight for the duration of the study (i.e. no more than 3 kg weight loss/gain).
6. Located within 15km of Ashwood, Melbourne.
7. Access to a smartphone and willing to download and use free applications from the app store
8. Access to a personal email inbox
9. Willing and able to provide Informed Consent
10. Understand the study requirements, including faecal sampling and willing to adhere closely to prescribed food consumption as per the research protocol.
11. Willing to maintain regular dietary pattern and level of physical activity
Minimum age
22 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Use of any of the following types of supplements within 28 days of clinic screening and not prepared to abstain from use for the study duration: laxatives, fibre supplements
2. Aversion and/or intolerance/allergy to any of the following: gluten, spelt, egg, tree nuts, lupin or FODMAPs.
3. Have a significant acute or chronic illness (i.e., psychiatric, gastrointestinal, cardiovascular [except uncontrolled hypertension], endocrine or immunological) or any condition that in the opinion of the Principal Investigator (PI) or Designee may affect the applicant’s ability to participate in the study or the study results
4. Have experienced a cardiovascular event such as congestive heart failure, heart attack, stroke, or angina (chest pain) in the past 84 days from screening
5. Currently have, or have a history of, inflammatory bowel disease (e.g., ulcerative colitis, Chron’s disease), coeliac disease, irritable bowel syndrome, chronic constipation or regular bouts of diarrhea
6. History of Chemotherapy or Radiotherapy treatment within preceding two years of screening
7. Current smoker/vaper (or history of smoking/vaping including within last 6 months from screening)
8. Women of childbearing potential (WOCBP) who are self reported as currently pregnant or lactating
9. Currently hospitalised or any planned hospitalisations during the study that may affect the participant’s ability to comply with the study in the opinion of the PI or Designee
10. Self-reported alcohol intake exceeding 10 standard drinks per week on average over the four weeks preceding screening
11. Currently a night shift worker
12. Are currently, or in the past 30 days have been, enrolled in another investigational device or drug study(s), or are currently receiving other investigational agent(s) that in the opinion of the PI or Designee may affect the applicant’s ability to participate in the study or the study results
13. Have changed their usual dietary intake/pattern, within the past 28 days from screening
14. Are currently on a weight loss dietary pattern
15. Have self-reported body weight fluctuations of more than 5 kg within the last 3 months from screening.
16. Require concomitant treatment during screening/baseline period with any medication that could influence the gastrointestinal tract e.g. Loperamide
17. Have used probiotics or antibiotics in the last 28 days since screening

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analyses, comparing changes in gut health endpoints including fecal short chain fatty acid producing bacteria between high fibre and white bread will be performed using linear mixed models for repeated measures including treatment and time as fixed factors and treatment*time as interaction term. To assess whether the order in which participants received the study products affected responses, an interaction term for treatment*time*allocation order will be included in the model; if no significant treatment*time*allocation order interaction is observed, the interaction term will be removed from the model. A first-order autoregressive (AR(1)) repeated covariance type will be used and a random intercept per participant included. Assumptions underpinning mixed linear statistical analyses, namely normal distribution and homoscedasticity of residuals, will be assessed. The threshold for significance will be set at 0.05 (two-sided). Statistical analyses will be performed using SPSS software (IBM Corporation, New York, USA).

Using clinical trial data from a dietary intervention study by Akagawa et al (2021) it is estimated that a sample size of 21 would provide 80% power to detect a 3% increase in faecal butyric acid producing bacteria. To allow for a potential dropout rate of up to 20% (n=5), we will recruit 26 participants into the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2022
Actual
26/05/2022
Date of last participant enrolment
Anticipated
27/05/2022
Actual
15/07/2022
Date of last data collection
Anticipated
23/09/2022
Actual
22/08/2022
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311006 0
Commercial sector/Industry
Name [1] 311006 0
Bakers Delight
Country [1] 311006 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
POBOX 10041, Adelaide BC, 5000, South Australia, Australia
Country
Australia
Secondary sponsor category [1] 312319 0
None
Name [1] 312319 0
Address [1] 312319 0
Country [1] 312319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310557 0
CSIRO Health and Medical Human Ethics Committee
Ethics committee address [1] 310557 0
Ethics committee country [1] 310557 0
Australia
Date submitted for ethics approval [1] 310557 0
08/02/2022
Approval date [1] 310557 0
25/05/2022
Ethics approval number [1] 310557 0

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

Contacts
Principal investigator
Name 118074 0
Dr Damien Belobrajdic
Address 118074 0
POBOX 10041, Adelaide BC, 5000, South Australia, Australia
Country 118074 0
Australia
Phone 118074 0
+61 8 83038815
Fax 118074 0
Email 118074 0
damien.belobrajdic@csiro.au
Contact person for public queries
Name 118075 0
Damien Belobrajdic
Address 118075 0
POBOX 10041, Adelaide BC, 5000, South Australia,,Australia
Country 118075 0
Australia
Phone 118075 0
+61 8 83038815
Fax 118075 0
Email 118075 0
damien.belobrajdic@csiro.au
Contact person for scientific queries
Name 118076 0
Damien Belobrajdic
Address 118076 0
POBOX 10041, Adelaide BC, 5000, South Australia,,Australia
Country 118076 0
Australia
Phone 118076 0
+61 8 83038815
Fax 118076 0
Email 118076 0
damien.belobrajdic@csiro.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?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in approved proposal, e.g. for IPD meta-analyses
How or where can data be obtained?
The Principal Investigator will provide the data by email; damien.belobrajdic@csiro.au.


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.