The Gut Microbiota in Stress, Mood and Eating Behaviours.

University of Roehampton

Status: Unknown

Conditions: Eating Behavior; Mood; Stress

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Prebiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03482258

08459942

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Treatment Prebiotic

Experimental group

Description:

3 week daily dose of Vivinal-GOS (galacto-oligosaccharide)

Treatment:

Dietary Supplement: Prebiotic

Placebo

Placebo Comparator group

Description:

3 week daily dose of Maltodextrin

Treatment:

Dietary Supplement: Maltodextrin