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Gut-brain Axis, Brain Function, and Behaviour.

Sponsor
University of Oxford (Other)
Overall Status
Unknown status
CT.gov ID
NCT03554694
Collaborator
National Health and Medical Research Council, Australia (Other), Oxford Health Biomedical Research Centre (OH BRC) support scheme (Other), Wellcome Centre for Integrative Neuroimaging (Other), Monash University (Other)
30
Enrollment
1
Location
2
Arms
18.9
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Prebiotics
  • Dietary Supplement: Maltodextrin (placebo)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Does Stimulating Friendly Gut Bacteria Improve Brain Function and Behaviour?
Actual Study Start Date :
May 6, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Start with prebiotics

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.

Dietary Supplement: Prebiotics
Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks
Experimental: Start with placebo

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.

Dietary Supplement: Maltodextrin (placebo)
Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks

Outcome Measures

Primary Outcome Measures

  1. Cortisol awakening response (CAR) [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).]

    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)

  2. Brain imaging (BOLD fMRI activity) in amygdala and cortical regions [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).]

    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)

Secondary Outcome Measures

  1. Changes in gut microbiome [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).]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Trait anxiety levels > 40 on STAI trait inventory

  • Participant is willing and able to give informed consent for participation in the study

  • Not currently taking any psychoactive medications

Exclusion Criteria:

  • Pregnant participants

  • No contraindications to prebiotic administration

  • Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.

  • Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.

  • Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.

  • Any significant change in diet which, at the discretion of the Investigators, may affect the results.

  • Participants who have recently participated in another research trial which, at the discretion of the Investigators, may affect the results.

  • A history of dementia, traumatic brain injury or stroke.

  • Anyone who is unable to perform the behavioural tasks.

  • Current use of any psychoactive medication.

  • Current use of psychological treatment.

  • Anyone who does not have adequate understanding of English, sufficient to give informed consent.

  • Any person who has a history of drug abuse or a previous history of a neurological, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.

  • Anyone with any metal implants or implantable device would be excluded from any brain imaging studies as indicated by the MRI safety screening form.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oxford Oxford Oxfordshire United Kingdom OX3 9DU

Sponsors and Collaborators

  • University of Oxford
  • National Health and Medical Research Council, Australia
  • Oxford Health Biomedical Research Centre (OH BRC) support scheme
  • Wellcome Centre for Integrative Neuroimaging
  • Monash University

Investigators

  • Principal Investigator: Jacinta O'Shea, PhD, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT03554694
Other Study ID Numbers:
  • R52324_RE001
First Posted:
Jun 13, 2018
Last Update Posted:
Jun 13, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 13, 2018