The Modulatory Effects of Dietary Fibres on the Composition and Function of the Gut Microbiome- A Dose-response Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in microbiome profile
研究概览
简要总结
The study involves taking pectin fibre at increasing doses ranging from 5g, 10g and 15g for a total period of 6 weeks with the increase every 2 weeks. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 4 occasions; at the start of the intervention and every 2 weeks, at the end of each dosing period. At each study visit (~3hrs), participants will be asked to provide a stool and blood sample and will have blood pressure measured. In the week before each study visit, participants will record their food intake.
详细描述
The study aims to assess the optimal dosage of pectin required to see beneficial effects on inflammation and gut microbiome composition. 15 healthy, non-obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and at the end of each dosing period (before each study visit), participants will be asked to complete a dietary record (4 days), to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit.
At both study visits, participants will have weight, hip/waist circumference and blood pressure measured. They will be asked to complete some questionnaires. After completion of the first study day, participants will be provided with the required dosage of pectin for the 2-week dosing period. They will be given the required doses of pectin portioned in individual sachets, with instructions to add the contents of one sachet a day to juice, smoothies or water and to consume immediately. Study visits will be scheduled at the end of every 2-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
排除标准
- •Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- •Are taking the following medications: immunosuppressants, anti-histamines, amiodarone and/or perhexiline
- •Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program/ taking prebiotic supplements
- •Pregnant or breast feeding
- •History or current psychiatric illness
- •History or current neurological condition (e.g. epilepsy)
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
研究组 & 干预措施
Dose response effect of Pectin
In order to investigate the dose-response effect of dietary pectin fibre, pectin was provided to healthy volunteers in increasing doses of 5g, 10g and 15g for a period of 2 weeks each with samples and data collected prior to each dosing period.
干预措施: Pectin dosages (Dietary Supplement)
结局指标
主要结局
Change in microbiome profile
时间窗: 6 weeks
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks)
Changes in short chain fatty acids (SCFAs)
时间窗: 6 weeks
Change in serum SCFAs measured by mass spectrometry at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
Change in inflammatory profile
时间窗: 6 weeks
Change in circulating markers of inflammation measured by ELISAs in serum samples collected at the start (pre-intervention) and end of every dosing period (i.e. 2 weeks).
次要结局
- Change in systolic blood pressure (lying to standing) pre intervention(6 weeks)
- Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score(6 weeks)
- Dose response change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score(6 weeks)
- Change in diastolic blood pressure (lying to standing) post every dosing period(6 weeks)
- Dose response change in Pittsburgh Sleep Quality Index (PSQI)(6 weeks)
- Dose response change in Hospital Anxiety and Depression scores (HADS)(6 weeks)
- Change in systolic blood pressure (lying to standing) post every dosing period(6 weeks)
- Change in diastolic blood pressure (lying to standing) at pre intervention study visit(6 weeks)
研究者
Elizabeth Simpson
Senior Research Fellow
University of Nottingham