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

NCT05931562 | Recruiting

• 1 other identifier: APC 150b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Microbiota-gut-brain axis; Diet; Cognition; Stress; Dietary Fibre; Fermented foods

Outcome Measures

Primary Outcomes (5)

• Trait stress/mood: self-report

  self-report questionnaires

  Change from baseline at 8 weeks

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

  Cortisol from saliva samples

  Change from baseline at 8 weeks

• Responses to acute stress: self-report

  Self-report questionnaires

  Change from baseline at 8 weeks

• Responses to acute stress: sympathetic-adrenal-medullary pathway activity

  Galvanic skin response taken from the skin on the hand

  Change from baseline at 8 weeks

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

  Cortisol from saliva samples

  Change from baseline at 8 weeks

Secondary Outcomes (12)

• Cognitive performance: working memory

  Change from baseline at 8 weeks

• Cognitive performance: episodic memory

  Change from baseline at 8 weeks

• Cognitive performance: decision making

  Change from baseline at 8 weeks

• Cognitive performance: emotional inhibition

  Change from baseline at 8 weeks

• Cognitive performance: sustained attention

  Change from baseline at 8 weeks

Study Arms (4)

Control

ACTIVE COMPARATOR

Participants will recieve dietary education based on the healthy eating guidleines provided by the Health Service Executive (HSE).

Other: Control

Fermented Foods

EXPERIMENTAL

Fermented foods diet (4-6 portions/day)

Other: Fermented Foods

High Fibre

EXPERIMENTAL

High fibre diet (24-35 grams/day)

Other: High Fibre

Combined Diet

EXPERIMENTAL

Combined diet high in fibre and fermented foods (fibre aim 24-35 grams/day, fermented foods aim 4-6 portions/day)

Other: Combined Diet

Interventions

Fermented Foods OTHER

Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.

Fermented Foods

High Fibre OTHER

Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.

High Fibre

Combined Diet OTHER

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.

Combined Diet

Control OTHER

Participants will recieve dietary education based on the Irish healthy food pyramid.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).
• Females who are peri-menopausal, menopausal or post-menopausal.
• Females who are pregnant or planning a pregnancy, or lactating.
• Participants who are not fluent in English.
• Are colour blind.
• Have dyslexia or dyscalculia.
• Are a current habitual daily smoker.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
• Subjects receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
• Have a malignant disease or any concomitant end-stage organ disease.
• Have completed a study in our laboratory in the past 4 years.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

APC Microbiome Ireland

Cork, T12YT20, Ireland

RECRUITING

MeSH Terms

Interventions

Fermented Foods

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John Cryan, PhD

  APC Microbiome Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Schneider, PhD

CONTACT

(+353) 021 4901721; eschneider@ucc.ie

Revathy Munuswamy

CONTACT

RMunuswamy@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized-controlled, parallel, single-blinded design

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 5, 2023
• Study Start: July 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

IE (1)