The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in systemic inflammatory profile
研究概览
简要总结
The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.
详细描述
The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.
Specific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.
Specific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have a smart phone in order to download apps on phone
排除标准
- •Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)
- •Have lactose intolerance
- •Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.
- •Are currently taking fibre or probiotic supplements
- •Are taking any prescribed medication
- •Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
- •Are pregnant or breast feeding
- •Currently have a diagnosed psychiatric illness
- •History or current neurological condition (e.g. epilepsy)
- •Have taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
结局指标
主要结局
Change in systemic inflammatory profile
时间窗: 6 weeks
Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.
次要结局
- Change in gut microbiome profile(6 weeks)
- Changes in short chain fatty acids (SCFAs)(6 weeks)
- Mental Wellbeing as measured by validated questionnaires(6 weeks)
- Changes in skin microbiome profile(6 weeks)
研究者
Elizabeth Simpson
Senior Research Fellow
University of Nottingham