Clinical trial NCT03482258: The Gut Microbiota in Stress, Mood and Eating Behaviours.
Official title: The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Behavior
Stress
Mood
Keywords: Stress
Galactooligosaccharide
Prebiotic
Early life stress
Emotional eating
Gut microbiota
Short-chain fatty acids
Serotonin
Cortisol
Lead sponsor: University of Roehampton
Sponsor class: OTHER
Collaborators: name: FrieslandCampina
First posted: 2018-03-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1. Training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements
2. 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.
3. Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).
4. (one week after last visit) collection of final faecal sample

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Antibiotic, prebiotic or probiotic use in past three months
* Pre-existing gastrointestinal disorders

Primary outcomes:
measure: Gut microbiota composition
timeFrame: 4 weeks
Secondary outcomes:
measure: Negative affect
timeFrame: 4 weeks
measure: Gut Brain Axis
timeFrame: 4 weeks
measure: Eating behaviour
timeFrame: 4 weeks
measure: Stress response
timeFrame: 4 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Roehampton
Study officials:
affiliation: University of Roehampton
name: Leigh Gibson
role: STUDY_DIRECTOR
References: