Gut-brain Axis, Brain Function, and Behaviour.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-06

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prebiotics Anxiety Humans Magnetic Resonance Imaging Decision Making Emotion Cortisol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Prebiotics

Intervention Type DIETARY_SUPPLEMENT

Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks

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.

Group Type EXPERIMENTAL

Maltodextrin (placebo)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prebiotics

Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin (placebo)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes