Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Gut Microbiota in Stress, Mood and Eating Behaviours.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482258
Recruitment Status : Unknown
Verified April 2019 by Ellie Haydon-Islam, University of Roehampton.
Recruitment status was:  Recruiting
First Posted : March 29, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
FrieslandCampina
Information provided by (Responsible Party):
Ellie Haydon-Islam, University of Roehampton

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Eating Behavior Stress Mood Dietary Supplement: Prebiotic Dietary Supplement: Maltodextrin Not Applicable

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Blinding of supplements will be conducted by Frieslandcampina who are providing both prebiotic and maltodextrin
Primary Purpose: Prevention
Official Title: The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment Prebiotic
3 week daily dose of Vivinal-GOS (galacto-oligosaccharide)
 Dietary Supplement: 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).
Other Name: Vivinal-GOS
Placebo Comparator: Placebo
3 week daily dose of Maltodextrin
 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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Gut microbiota composition [ Time Frame: 4 weeks ]

    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



Secondary Outcome Measures :
  1. Negative affect [ Time Frame: 4 weeks ]
    To observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test).

  2. Gut Brain Axis [ Time Frame: 4 weeks ]

    To 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


  3. Eating behaviour [ Time Frame: 4 weeks ]

    To 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).


  4. Stress response [ Time Frame: 4 weeks ]

    To observe whether treatment with GOS moderates the stress response

    Cortisol awakening response will be measured via saliva samples.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482258


Contacts
Layout table for location contacts
Contact: Ellie Haydon-Islam 02083923440 haydonie1@roehampton.ac.uk
Contact: Leigh Gibson, PhD 02083923744 l.gibson@roehampton.ac.uk

Locations
Layout table for location information
United Kingdom
University of Roehampton Recruiting
London, United Kingdom, SW15 5PJ
Contact: Ellie Haydon-Islam         
Sponsors and Collaborators
University of Roehampton
FrieslandCampina
Investigators
Layout table for investigator information
Study Director: Leigh Gibson University of Roehampton
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ellie Haydon-Islam, PhD student, University of Roehampton
ClinicalTrials.gov Identifier: NCT03482258    
Other Study ID Numbers: 08459942
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellie Haydon-Islam, University of Roehampton:
Stress
Galactooligosaccharide
Prebiotic
Early life stress
Emotional eating
 Gut microbiota
Short-chain fatty acids
Serotonin
Cortisol