Towards Personalized Dietary Recommendations Based on the Interaction Between Diet, Microbiome and Abiotic Conditions in the Gut
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Faecal pH vs gut microbial saccharolytic/proteolytic metabolism
研究概览
简要总结
The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.
详细描述
The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The participants will throughout the trial register their dietary intake, gastrointestinal symptoms including stool frequency and Bristol stool scale, physical activity, and medicine and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet corns to estimate intestinal transit time by the time it takes sweet corn to travel through the gastrointestinal system. Furthermore, the participants will collect daily urine and stool samples.
On day 2 and day 9, participants will arrive fasting at the department in the morning and have their anthropometry, breath hydrogen and methane levels measured, and a blood sample will be collected from each participant.
The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg, and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the participants will stay at the department for the following 6 hours and have their postprandial breath hydrogen and methane measured and urine collected at specific intervals.
Moreover, a sub-set of the participants will on the first visit (day 2) immediately after intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule, which will monitor their gastrointestinal pH, transit time, temperature and pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18.5-30.0 kg/m2 BMI
- •Willing to daily collect a urine and stool sample at home and able to store them in their own freezer in a provided containers throughout the 9-days trial
- •Willing to eat sweet corn and report corn-intestinal transit time questionnaire
- •Willing to record 9 days dietary intake and defecation pattern
- •Willing to have blood samples drawn two times
- •Owns a device with access to the internet and is willing to use myfood24 platform
- •Known ability to tolerate paracetamol and willing to consume ½ paracetamol tablet dissolved in water (250mg)
- •Willing to eat rye bread, butter, jam, egg, yoghurt, berries and nuts
排除标准
- •Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
- •Pregnant or lactating women
- •Suffering from inflammatory bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) or inflammatory bowel diseases (IBD)
- •Intake of antibiotics, diarrhea inhibitors and laxatives ˂ 1month
- •Current chronic or infectious diseases
- •Diagnosis of diabetes
- •History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- •Frequent intake of painkillers or other medication (mild antidepressants and contraceptive pills are allowed)
- •Concurrent participation in another trial
- •Additional exclusion criteria for the SmartPill sub-study:
- •Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
- •Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anticholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs)
- •Dysphagia
结局指标
主要结局
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism
时间窗: Day 1-9
We test whether faecal pH is positively associated with microbial-derived proteolytic metabolites (i.e. p-cresol sulfate and phenylacetylglutamine) in urine and negatively associated with microbial-derived saccharolytic metabolites in faeces (i.e. acetate, butyrate and propionate)
次要结局
- Abiotic factors vs urine metabolome(Day 1-9)
- Abiotic factors vs blood metabolome(Day 2 and 9)
- Abiotic factors vs microbial-derived metabolites(Day 1-9)
- Faecal metagenomics profile vs metabolome(Day 1-9)
- Abiotic factors vs faecal metagenomic profile(Day 1-9)
- Abiotic factors vs faecal metabolome(Day 1-9)
研究者
Henrik Munch Roager
Associate Professor
University of Copenhagen