To maintain gastrointestinal health, dietary fibre is recognised as an important factor, but people in many developed countries continue to consume half the recommended daily amount.
Consistent with this, Australians consume on average 20g of dietary fibre per day which is well short of the 30g or higher levels that have been shown to reduce risk of developing diseases of the gastrointestinal tract, such as colorectal cancer, and up to 30% reduced risk of all-cause and cardiovascular related mortality, coronary heart disease incidence, stroke incidence and mortality and type-2 diabetes
About this study
This study will try to establish if the digestive health advantages of a high fibre bread compared to low-fibre white bread over a two week period will contribute to improving the health of the Australian community. This study is funded by Bakers Delight.
Who can participate in this study?
Healthy people aged 22 - 55 years who are parents and caregivers of children aged 5-12 years of age may be eligible to participate in this study. Twenty-six individuals will participate in this clinical trial in Melbourne.
These criteria along with other further criteria related to your health will be assessed for you during the screening process.
How to participate
If you feel you fit the criteria below and would like to take part, please complete the online study registration form selecting “Digestive Health” from the drop-down menu.
- People aged 22 -55 years of age
- Be a parent or carer for at least one child aged 5 -12 years
- BMI more than 18.5 and less than 29.9 at time of clinic screening
- Willing to maintain body weight for the duration of the study (i.e. no more than 3 kg weight loss/gain).
- Located within 15km of Ashwood, Melbourne.
- Access to a smartphone and willing to download and use free applications from the app store
- Access to a personal email inbox
- Willing and able to provide Informed Consent
- Understand the study requirements, including faecal sampling and willing to adhere closely to prescribed food consumption as per the research protocol.
- Willing to maintain regular dietary pattern and level of physical activity
- 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
- Aversion and/or intolerance/allergy to any of the following: gluten, spelt, tree nuts, lupin or FODMAPs.
- 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
- Have experienced a cardiovascular event such as congestive heart failure, heart attack, stroke, or angina (chest pain) in the past 84 days from screening
- Currently have, or have a history of, inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease), coeliac disease, irritable bowel syndrome, chronic constipation or regular bouts of diarrhea
- History of Chemotherapy or Radiotherapy treatment within preceding two years of screening
- Current smoker/vaper (or history of smoking/vaping including within last 6 months from screening)
- Women of childbearing potential (WOCBP) who are self reported as currently pregnant or lactating
- 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
- Self-reported alcohol intake exceeding 10 standard drink* per week on average over the four weeks preceding screening
- Currently a night shift worker
- 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
- Have changed their usual dietary intake/pattern, within the past 28 days from screening
- Are currently on a weight loss dietary pattern
- Have self-reported body weight fluctuations of more than 5 kg within the last 3 months from screening.
- Require concomitant treatment during screening/baseline period with any medication that could influence the gastrointestinal tract e.g. Loperamide
- Have used probiotics or antibiotics in the last 28 days since screening
If you have any queries about this study or would like further information about participating do not hesitate to contact us, either by phone please call (08) 8305 0615 or email CRUstudies@csiro.au and we can assist.
This study has been approved by the CSIRO Health and Medical Research Human Research Ethics Committee.
If you would like to speak with someone with respect to ethical matters or wish to register a formal complaint about the conduct of this research, please contact the Secretary of the Committee via email at email@example.com or phone on (07) 3833 5693.