High fermentable fibre bread consumption and the bowel health of Australian parents and caregivers of children.

Not Applicable

Completed

• Conditions: Poor gut health; Low fibre consumption; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000535774
• Lead Sponsor: CSIRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-05
• Study Completion: 2022-08-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
short chain fatty acid producing bacteria (%relative abundance) assessed using a stool sample[Baseline, 2 weeks post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Stool consistency assessed using the Bristol stool rating chart (no units)[Baseline, 2 weeks post-intervention commencement];Gut comfort assessed using the Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire (no units)[Baseline, 2 weeks post-intervention commencement];Firmicutes/Bacteroidetes ratio assessed in stool samples[Baseline, 2 weeks post-intervention commencement];Microbial diversity assessed in stool samples[Baseline, 2 weeks post-intervention commencement]