Does Stimulating Friendly Gut Bacteria Improve Brain Function and Behaviour?
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brain imaging (BOLD fMRI activity) in amygdala and cortical regions
研究概览
简要总结
The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Both intervention and placebo products are similar in colour, texture, and taste. A third party, independent of the daya-to-day research coordinator, will randomise treatments.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trait anxiety levels > 40 on STAI trait inventory
- •Participant is willing and able to give informed consent for participation in the study
- •Not currently taking any psychoactive medications
排除标准
- •Pregnant participants
- •No contraindications to prebiotic administration
- •Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.
- •Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.
- •Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.
- •Any significant change in diet which, at the discretion of the Investigators, may affect the results.
- •Participants who have recently participated in another research trial which, at the discretion of the Investigators, may affect the results.
- •A history of dementia, traumatic brain injury or stroke.
- •Anyone who is unable to perform the behavioural tasks.
- •Current use of any psychoactive medication.
- •Current use of psychological treatment.
- •Anyone who does not have adequate understanding of English, sufficient to give informed consent.
- •Any person who has a history of drug abuse or a previous history of a neurological, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
- •Anyone with any metal implants or implantable device would be excluded from any brain imaging studies as indicated by the MRI safety screening form.
研究组 & 干预措施
Start with prebiotics
Half of the participants start with prebiotics, followed by a testing period. After a wash-out period they will continue with placebo followed by a testing period.
干预措施: Prebiotics (Dietary Supplement)
Start with placebo
Half of the participants start with placebo, followed by a testing period. After a wash-out period they will continue with prebiotics followed by a testing period.
干预措施: Maltodextrin (placebo) (Dietary Supplement)
结局指标
主要结局
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions
时间窗: Brain imaging will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions Will provide neural measures of threat reactivity. We predict decreased amygdala and/or increased parietal-prefrontal brain activity after prebiotics compared to placebo, indicating an anxiolytic-like profile (fearful -neutral face trials in the low load condition) (as in Bishop et al, 2007 and Ironside et al, 2017)
Cortisol awakening response (CAR)
时间窗: Cortisol awakening responses will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
CAR, a marker of stress responsivity, should be decreased after taking prebiotics compared to placebo (as previously found in non-anxious participants in Schmidt et al., 2015, Psychopharmacology)
次要结局
- Changes in gut microbiome(Changes in the microbiome will be measure using a single stool/faecal sample at four time points: baseline (0 weeks), following first intervention (4-6 weeks), following washout (7-9 weeks), and following the second intervention (11-15 weeks).)