The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota

ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUniversity College Cork

About this trial

This study aims to investigate the relationship between diet and the microbiota-gut-brain axis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able to give written informed consent.

Be between 18 and 50 years of age.

Have a body mass index (BMI) between 18.5-29.9 Kg/m2.

Be in generally good health as determined by the investigator.

Disqualifiers

Are less than 18 and greater than 50 years of age.

Have a BMI below 18.5 or above 29.9 Kg/m2.

Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal (GI) [to include functional GI disorders, inflammatory bowel disease, coeliac disease, lactose intolerance, food allergies], immunological, psychiatric [to include formal or as determined by MINI Psychiatric interview, diagnosis of current major depression, anxiety disorder, bipolar spectrum disorder, schizophrenia, other DSM-IV Axis I disorder], neurodevelopmental disorders, immunological, metabolic disorders [to include type I or II diabetes], or any condition which contraindicates, in the investigators judgement, entry to the study.

Have a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; all psychoactive medications [to include anxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids, and opioid pain relievers), laxatives, enemas, antibiotics, anti-coagulants, over-the counter non-steroidal anti-inflammatories (NSAIDS). Subjects should have a wash-out period of 4 weeks.

Trial population

Healthy adult volunteers consuming varying amounts of dietary fibre.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Dietary fibre

    Other intervention

    Habitual dietary consumption from a variety of foods will be assessed using 7-day food logs entered by the participant and assessed for accuracy by a dietitian.

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: Low fibre consumers1 intervention
Group B: Moderate fibre consumers1 intervention
Group C: High fibre consumers1 intervention

Trial outcomes

Primary outcomes

1

Trait stress/mood: self-report

Self-report questionnaires

Time frame
Compared at baseline
2

Trait stress/mood: hypothalamic-pituitary-adrenal axis activity

Cortisol from saliva samples

Time frame
Compared at baseline
3

Responses to acute stress: self-report

Self-report questionnaires

Time frame
Compared at baseline
4

Responses to acute stress: hypothalamic-pituitary-adrenal axis activity

Cortisol from saliva samples

Time frame
Compared at baseline

Secondary outcomes

1

Cognitive performance: working memory

Spatial Working Memory

Time frame
Compared at baseline
2

Cognitive performance: episodic memory

Modified Rey Auditory Verbal Learning Test (ModRey)

Time frame
Compared at baseline
3

Cognitive performance: decision making

Iowa Gambling Task

Time frame
Compared at baseline
4

Cognitive performance: emotional inhibition

Emotional stroop

Time frame
Compared at baseline

Other outcomes

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