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| Name | Class |
|---|---|
| FrieslandCampina | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Prebiotic | Experimental | 3 week daily dose of Vivinal-GOS (galacto-oligosaccharide) |
|
| Placebo | Placebo Comparator | 3 week daily dose of Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Negative affect | To observe whether treatment with GOS moderates negative affect using cognitive tasks (Affective GoNoGo and Emotion Recognition test). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellie Haydon-Islam | Contact | 02083923440 | haydonie1@roehampton.ac.uk | |
| Leigh Gibson, PhD | Contact | 02083923744 | l.gibson@roehampton.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Leigh Gibson | University of Roehampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Roehampton | Recruiting | London | SW15 5PJ | United Kingdom |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D013315 | Stress, Psychological |
| D000098382 | Emotional Eating |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Blinding of supplements will be conducted by Frieslandcampina who are providing both prebiotic and maltodextrin
|
| Maltodextrin | Dietary 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). |
|
| 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). | 4 weeks |
| Stress response | To observe whether treatment with GOS moderates the stress response Cortisol awakening response will be measured via saliva samples. | 4 weeks |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |