The Impact of Diet on the Gut-Microbiota-Brain Axis

ConditionHealthy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorUniversity College Cork

About this trial

This study aims to investigate the effects of an 8-week dietary intervention on cognitive function, stress, and the gut microbiota in healthy adults with low fibre intake.

Eligibility criteria

This trial accepts 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 design

Design model

Factorial

Treatments tested in this trial

Fermented Foods
Other intervention
Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
High Fibre
Other intervention
Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
Combined Diet
Other intervention
Participants will recieve dietary education to increase their fibre intake to 25-30g/day and include 3 to 4 portions of fermented foods to their normal diet.
Control
Other intervention
Participants will recieve dietary education based on the Irish healthy food pyramid.

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: Fermented FoodsExperimental treatment 1 intervention

Group C: High FibreExperimental treatment 1 intervention

Group D: Combined DietExperimental treatment 1 intervention

Trial outcomes