Gut-brain Axis, Brain Function, and Behaviour.

University of Oxford

Status: Unknown

Conditions: Decision Making; Humans; Prebiotics; Emotion; Anxiety; Cortisol; Magnetic Resonance Imaging

Treatments: Dietary Supplement: Prebiotics; Dietary Supplement: Maltodextrin (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT03554694

R52324_RE001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Start with prebiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Prebiotics

Start with placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Maltodextrin (placebo)