NCT03482258

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

March 14, 2018

Last Update Submit

April 16, 2019

Conditions

Eating BehaviorStressMood

Keywords

StressGalactooligosaccharidePrebioticEarly life stressEmotional eatingGut microbiotaShort-chain fatty acidsSerotoninCortisol

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

    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

    4 weeks

Secondary Outcomes (4)

  • Negative affect

    4 weeks

  • Gut Brain Axis

    4 weeks

  • Eating behaviour

    4 weeks

  • Stress response

    4 weeks

Study Arms (2)

Treatment Prebiotic

EXPERIMENTAL

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

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

3 week daily dose of Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

PrebioticDIETARY_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).

Also known as: Vivinal-GOS
Treatment Prebiotic
MaltodextrinDIETARY_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).

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Roehampton

London, SW15 5PJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorStress, PsychologicalEmotional Eating

Interventions

Prebioticsmaltodextrin

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Leigh Gibson

    University of Roehampton

    STUDY DIRECTOR

Central Study Contacts

Ellie Haydon-Islam

CONTACT

02083923440haydonie1@roehampton.ac.uk

Leigh Gibson, PhD

CONTACT

02083923744l.gibson@roehampton.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blinding of supplements will be conducted by Frieslandcampina who are providing both prebiotic and maltodextrin
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 29, 2018

Study Start

February 1, 2019

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

GB(1)