None listed
Conditions
Brief summary
While the role of dietary fibre for the maintenance of gut health is well recognised, typical dietary consumption in Australian adults remains below recommendations. Further, there are many types of dietary fibre, each with different health benefits. In particular, fermentable fibres such as beta glucan and fructans that can impact gut microbe activity, are less likely to be consumed than standard stool bulking agent fibres such as cellulose. This study uses bread as the test product, a common source of dietary fibre for Australians, to pose the question of whether the simple replacement of white fibre bread with a highly fermentable fibre (barleyMAX) bread is achievable and effective in increasing the fibre intake and gut health of Australian parents/caregivers, a group whose busy lifestyle often can result in less favourable dietary patterns, and who can be tested as ideal role models for increasing dietary fibre consumption for the whole family unit.
Interventions
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 adv
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.
Sponsors
CSIRO
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
22 Years to 55 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed