Eating BehaviorNCT03482258
The Gut Microbiota in Stress, Mood and Eating Behaviours.
A study testing Prebiotic and Maltodextrin in people with Eating Behavior and Stress, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Stress, Mood
- What is being tested?
- Prebiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Antibiotic, prebiotic or probiotic use in past three months
- Pre-existing gastrointestinal disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Roehampton
London, SW15 5PJ
Ellie Haydon-Islam
About this study
Official title: The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.
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.
Read the 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:
- Training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements
- 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.
- Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).
- (one week after last visit) collection of final faecal sample
- Conditions
- Eating Behavior, Stress, Mood
- Being tested
- Prebiotic, Maltodextrin
- Keywords
- Stress, Galactooligosaccharide, Prebiotic, Early life stress, Emotional eating, Gut microbiota, Short-chain fatty acids, Serotonin, Cortisol
- Medical subject headings
- Feeding Behavior, Stress, Psychological, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Also called Vivinal-GOS
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Prebiotic | Experimental | 3 week daily dose of Vivinal-GOS (galacto-oligosaccharide) Receives: Dietary Supplement: Prebiotic |
| Placebo | Placebo comparator | 3 week daily dose of Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
Negative affect
To observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test).
Measured: 4 weeks
Gut Brain Axis
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
Measured: 4 weeks
Eating behaviour
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).
Measured: 4 weeks
Stress response
To observe whether treatment with GOS moderates the stress response
Cortisol awakening response will be measured via saliva samples.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Feb 2019
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Ellie Haydon-Islam, University of Roehampton
- Investigators
- Leigh Gibson, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482258
- Sponsor's protocol ID
- 08459942
- Status last verified
- Apr 2019
- First submitted
- 14 Mar 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prebiotic Galacto-oligosaccharide on Stress Related Eating Behaviours and Mood.
- ClinicalTrials.gov ID
- NCT03482258
- Acronym / sponsor ID
- 08459942
- Conditions
- Eating Behavior, Stress, Mood
- Keywords
- Stress, Galactooligosaccharide, Prebiotic, Early life stress, Emotional eating, Gut microbiota, Short-chain fatty acids, Serotonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Training on how to complete food diaries and collect saliva samples for cortisol awakening response measurements
- 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.
- Cognitive (Affective GoNoGo and Emotion Recognition Task) and biologic measurements (blood,faecal). This also includes a stress inducing task (Fake Speech Task).
- (one week after last visit) collection of final faecal sample
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Prebiotic | Experimental | Dietary Supplement: Prebiotic3 week daily dose of Vivinal-GOS (galacto-oligosaccharide) |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin3 week daily dose of Maltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Antibiotic, prebiotic or probiotic use in past three months
- Pre-existing gastrointestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticAlso: Vivinal-GOSA 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 supplement | Treatment Prebiotic |
| MaltodextrinA 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). | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Negative affect
Time frame: 4 weeks
Gut Brain Axis
Time frame: 4 weeks
Eating behaviour
Time frame: 4 weeks
Stress response
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Gibson study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic and Maltodextrin in people with Eating Behavior and Stress, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellie Haydon-Islam (02083923440, haydonie1@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.