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

NCT05931536 | Recruiting

• 1 other identifier: APC150a
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Microbiota-gut-brain axis; Diet; Cognition; Stress; Dietary fibre

Outcome Measures

Primary Outcomes (5)

• Trait stress/mood: self-report

  Self-report questionnaires

  Compared at baseline

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

  Cortisol from saliva samples

  Compared at baseline

• Responses to acute stress: self-report

  Self-report questionnaires

  Compared at baseline

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

  Cortisol from saliva samples

  Compared at baseline

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

  Galvanic skin response taken from the skin on the hand

  Compared at baseline

Secondary Outcomes (12)

• Cognitive performance: working memory

  Compared at baseline

• Cognitive performance: episodic memory

  Compared at baseline

• Cognitive performance: decision making

  Compared at baseline

• Cognitive performance: emotional inhibition

  Compared at baseline

• Cognitive performance: sustained attention

  Compared at baseline

Study Arms (3)

Low fibre consumers

Healthy adults consuming less than or equal to 18 grams of fibre per day.

Other: Dietary fibre

Moderate fibre consumers

Healthy adults consuming between 18.1-24.9 grams of fibre per day.

Other: Dietary fibre

High fibre consumers

Healthy adults consuming greater than or equal to 25 grams of fibre per day.

Other: Dietary fibre

Interventions

Dietary fibre OTHER

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.

High fibre consumers; Low fibre consumers; Moderate fibre consumers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers consuming varying amounts of dietary fibre.

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, urine, and stool

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

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

Study Officials

• John F Cryan, PhD

  APC Microbiome Irealnd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Schneider, PhD

CONTACT

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

Revathy Munuswamy, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 5, 2023
• Study Start: July 14, 2022
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

IE (1)