Differences Between Coffee and Non-coffee Drinkers in the Gut Microbiome and Microbiota-Gut-Brain Axis

NCT05927103 | Completed

• 1 other identifier: APC115a
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the potential of coffee to act as a prebiotic to alter gut microbiota and improve mood, memory and cognitive performance.

Conditions

Healthy

Keywords

Coffee; Microbiome-gut-brain-axis; Stress; Polyphenols; Cognition; Microbiota; Mood; Behaviour; Inflammation

Outcome Measures

Primary Outcomes (1)

• Gut Microbiota composition

  Shotgun metagenomics of fecal samples will be performed to quantify the proportion of bacterial taxa within the gut.

  Difference between the groups at baseline.

Secondary Outcomes (2)

• Gut microbial metabolites (including Short-Chain fatty acids)

  Difference between the groups at baseline.

• Coffee-related metabolites

  Difference between the groups at baseline.

Other Outcomes (10)

• Cognitive performance: attention

  Difference between the groups at baseline.

• Cognitive performance - Episodic memory

  Difference between the groups at baseline.

• Cognitive performance - Learning and visual memory

  Difference between the groups at baseline.

Study Arms (2)

Coffee drinkers

Healthy adults between 30 and 50 years-old that consume 3 to 5 cups of caffeinate coffee daily

Non-coffee drinkers

Healthy adults between 30 and 50 years-old that never consume coffee

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers between 30 and 50 years old.

You may qualify if:

• Be able to give written informed consent.
• Be between 30 and 50 years of age.
• Be in generally good health as determined by the investigator.
• Drink moderate amounts of coffee daily (3-5 cups/day)

You may not qualify if:

• Are less than 30 and greater than 50 years of age.
• 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.
• Be hypertensive.
• Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study), or habitual consumption of foods deemed by the investigator to be particularly rich in prebiotic fibres or probiotic strains or are vegan.
• Females who are pregnant or planning a pregnancy, or lactating.
• Participants who are not fluent in English.
• Participants who 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 already done a study in the lab in the past 4 years

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, stool, blood and saliva samples

MeSH Terms

Conditions

Behavior; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John F Cryan, PhD

  UCC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 3, 2023
• Study Start: September 21, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)