An interventional study of Prebiotic and Maltodextrin in Eating Behavior, Stress and Mood, sponsored by University of Roehampton. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Roehampton · Not applicable, Interventional, and Prevention
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.
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:
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 30 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →University of Roehampton is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 week daily dose of Vivinal-GOS (galacto-oligosaccharide)
Dietary Supplement: Prebiotic
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 equates to 10g GOS (VGOS is primarily 69% GOS, 23% Lactose).
Also known as: Vivinal-GOS
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
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
Time frame: 4 weeks
Negative affect
To observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test).
Time frame: 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
Time frame: 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).
Time frame: 4 weeks
Stress response
To observe whether treatment with GOS moderates the stress response Cortisol awakening response will be measured via saliva samples.
Time frame: 4 weeks
Started Feb 2019 (actual). Primary completion is estimated for Aug 2019, 6 months after the start.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prebiotics
University of Roehampton