The Gut Microbiota in Stress, Mood and Eating Behaviours.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Eating Behavior Stress Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Blinding of supplements will be conducted by Frieslandcampina who are providing both prebiotic and maltodextrin

Study Groups

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Treatment Prebiotic

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

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DIETARY_SUPPLEMENT

A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This equates to 10g GOS (VGOS is primarily 69% GOS, 23% Lactose).

Placebo

3 week daily dose of Maltodextrin

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This will be matched to VGOS for lactose (3.3g per dose of maltodextrin will be lactose).

Interventions

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Prebiotic

A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This equates to 10g GOS (VGOS is primarily 69% GOS, 23% Lactose).

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This will be matched to VGOS for lactose (3.3g per dose of maltodextrin will be lactose).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vivinal-GOS

Eligibility Criteria

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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