ACTRN12622000535774已完成未知
Effect of highly fermentable fibre bread consumption on faecal short chain fatty acid producing bacteria in Australian parents and caregivers of children.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- CSIRO
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 22 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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