The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gut microbiota composition
研究概览
简要总结
Diet has a considerable influence on microbiota composition and the intake of either prebiotics (microbiota-specific food or probiotics (live microbiota species) has been shown to induce positive effects in both anxiety and depression. At present there are few studies exploring stress-related conditions such as emotional/comfort eating behaviours, particularly in individuals who have experienced early life stress and/or find stress difficult to deal with in regards to gut microbiome composition and subsequent behavioural outcomes. Early life stress has been linked to the development of bulimia nervosa and anorexia nervosa in adolescence and adulthood and since the gut microbiota has been proposed as having a causal role in the aetiology and/or maintenance of disordered eating, an empirical question is whether the microbiota may mediate the relation between stress and disordered eating. This is an investigation into the effects of chronic daily consumption of a prebiotic on stress-related eating and mood.
详细描述
Following an initial screening session based on inclusion/exclusion criteria, participants will be randomly allocated into either the treatment or placebo group and provided with three weeks worth of Vivinal-GOS or maltodextrin in powder form (sachets). There will be four clinical visits as detailed below:
- Training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements
- Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).Provided with supplement and invited to next session in three weeks' time.
- Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).
- (one week after last visit) collection of final faecal sample
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Blinding of supplements will be conducted by Frieslandcampina who are providing both prebiotic and maltodextrin
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A positive or negative screen for exposure to adverse childhood experiences
- •A positive or negative screen for stress/emotional related eating behaviours
- •Written informed consent
排除标准
- •Antibiotic, prebiotic or probiotic use in past three months
- •Pre-existing gastrointestinal disorders
结局指标
主要结局
Gut microbiota composition
时间窗: 4 weeks
A comparison of the microbiota between individuals who are or are not prone to stress/emotional eating behaviours potentially due to early life stress, and whether treatment with a prebiotic (GOS) alters this. Metagenomic studies will be conducted to evidence base outcomes linked to changes in microbial population 1HNMR profiling will be used to identify biochemical/ bioactive mechanisms for regulatory needs
次要结局
- Stress response(4 weeks)
- Negative affect(4 weeks)
- Gut Brain Axis(4 weeks)
- Eating behaviour(4 weeks)
研究者
Ellie Haydon-Islam
PhD student
University of Roehampton