Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Wellcome Centre for Integrative Neuroimaging | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start with prebiotics | Experimental | Half of the participants start with prebiotics, followed by a testing period. After a wash-out period they will continue with placebo followed by a testing period. |
|
| Start with placebo | Experimental | Half of the participants start with placebo, followed by a testing period. After a wash-out period they will continue with prebiotics followed by a testing period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotics | Dietary Supplement | Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol awakening response (CAR) | CAR, a marker of stress responsivity, should be decreased after taking prebiotics compared to placebo (as previously found in non-anxious participants in Schmidt et al., 2015, Psychopharmacology) | Cortisol awakening responses will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry). |
| Brain imaging (BOLD fMRI activity) in amygdala and cortical regions | Brain imaging (BOLD fMRI activity) in amygdala and cortical regions Will provide neural measures of threat reactivity. We predict decreased amygdala and/or increased parietal-prefrontal brain activity after prebiotics compared to placebo, indicating an anxiolytic-like profile (fearful -neutral face trials in the low load condition) (as in Bishop et al, 2007 and Ironside et al, 2017) | Brain imaging will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiome | Availability of specific bacteria in microbiome will change as function of prebiotics and not during placebo. The change will be measured at the start of each intervention compared to the end of each intervention | Changes in the microbiome will be measure using a single stool/faecal sample at four time points: baseline (0 weeks), following first intervention (4-6 weeks), following washout (7-9 weeks), and following the second intervention (11-15 weeks). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gershon Spitz, PhD | Contact | +44 (0)1865611456 | gershon.spitz@ndcn.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jacinta O'Shea, PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25449699 | Background | Schmidt K, Cowen PJ, Harmer CJ, Tzortzis G, Errington S, Burnet PW. Prebiotic intake reduces the waking cortisol response and alters emotional bias in healthy volunteers. Psychopharmacology (Berl). 2015 May;232(10):1793-801. doi: 10.1007/s00213-014-3810-0. Epub 2014 Dec 3. | |
| 16956980 | Background | Bishop SJ, Jenkins R, Lawrence AD. Neural processing of fearful faces: effects of anxiety are gated by perceptual capacity limitations. Cereb Cortex. 2007 Jul;17(7):1595-603. doi: 10.1093/cercor/bhl070. Epub 2006 Sep 6. |
Not provided
Not provided
The study staff will ensure that the participants' data are safeguarded. The study will comply with the Data Protection Act, which requires personal data to be anonymised as soon as it is practical to do so. Students and collaborators may be given access to fully anonymized data under the supervision of the named investigators. Some peer-reviewed journals require submission of anonymised data that may also be uploaded to other data sharing initiatives. Access may be given to responsible members of the University of Oxford for the purposes of monitoring or audit. The participants' consent will be sought if this is to occur.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
Not provided
Not provided
| Monash University | OTHER |
Crossover Assignment Randomised Double-blind Cross-over design with 4-6 weeks of prebiotics intervention and 4-6 weeks of placebo intervention. The first intervention phase will be followed by a 3 week wash-out period prior to the second intervention phase.d.
Not provided
Not provided
Both intervention and placebo products are similar in colour, texture, and taste. A third party, independent of the daya-to-day research coordinator, will randomise treatments.
| Maltodextrin (placebo) | Dietary Supplement | Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks |
|
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |