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The Gut Microbiota in Stress, Mood and Eating Behaviours.

The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03482258
Enrollment
30
Registered
2018-03-29
Start date
2019-02-01
Completion date
2019-11-30
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Behavior, Mood, Stress

Keywords

Stress, Galactooligosaccharide, Prebiotic, Early life stress, Emotional eating, Gut microbiota, Short-chain fatty acids, Serotonin, Cortisol

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

Interventions

DIETARY_SUPPLEMENTPrebiotic

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).

DIETARY_SUPPLEMENTMaltodextrin

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).

Sponsors

FrieslandCampina
CollaboratorINDUSTRY
University of Roehampton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota composition4 weeksA 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

Secondary

MeasureTime frameDescription
Negative affect4 weeksTo observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test).
Gut Brain Axis4 weeksTo gain further understanding of the mechanisms of the GBA by examining blood and/or faecal levels of SCFAs and TRP, in relation to behavioural outcomes and microbiota populations. SCFAs in serum will be measured via blood samples (ratio of acetate, propionate and butyrate) Levels of serum propionate in relation to satiety- plasma concentrations of PYY and GLP-1
Eating behaviour4 weeksTo observe whether participants engage stress related eating behaviours (over-eating, eating high energy foods) and if prebiotics negate these behaviours. This will be measured via a exposure to a stressful situation (fake speech task) and subsequent food consumption (a meal will provided).
Stress response4 weeksTo observe whether treatment with GOS moderates the stress response Cortisol awakening response will be measured via saliva samples.

Countries

United Kingdom

Contacts

Primary ContactEllie Haydon-Islam
haydonie1@roehampton.ac.uk02083923440
Backup ContactLeigh Gibson, PhD
l.gibson@roehampton.ac.uk02083923744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026