The Gut Microbiota in Stress, Mood and Eating Behaviours.
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|ClinicalTrials.gov Identifier: NCT03482258|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eating Behavior Stress Mood||Dietary Supplement: Prebiotic Dietary Supplement: Maltodextrin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|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|
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).
- 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
- Negative affect [ Time Frame: 4 weeks ]To observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test).
- 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
- 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).
- 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.
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
|Contact: Ellie Haydon-Islamfirstname.lastname@example.org|
|Contact: Leigh Gibson, PhDemail@example.com|
|University of Roehampton||Recruiting|
|London, United Kingdom, SW15 5PJ|
|Contact: Ellie Haydon-Islam|
|Study Director:||Leigh Gibson||University of Roehampton|