Coffee Consumption, the Gut Microbiome, and the Microbiota-Gut-Brain Axis

NCT05927038 | Completed

• 1 other identifier: APC115
• Study Type: interventional
• Target: 31
• 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; Prebiotic; Polyphenol; Cognition; Stress; Mood; Behavior; Inflammation; Gut Microbiota; Caffeine

Outcome Measures

Primary Outcomes (1)

• Microbiota composition and function

  Shotgun metagenomics of fecal samples

  Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention

Secondary Outcomes (2)

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

  Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention

• Coffee-related metabolites

  Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention

Other Outcomes (10)

• Cognitive performance: attention

  Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention

• Cognitive performance - Episodic memory

  Differences between groups at baseline and at 3-week coffee intervention

• Cognitive performance - Learning and visual memory

  Differences between groups at baseline and at 3-week coffee intervention

Study Arms (2)

Caffeinated coffee

EXPERIMENTAL

4 sachets (1.8 grams each) of instant, caffeinated coffee

Other: Caffeinated coffee

Decaffeinated coffee

EXPERIMENTAL

4 sachets (1.8 grams each) of instant, decaffeinated coffee

Other: Decaffeinated coffee

Interventions

Caffeinated coffee OTHER

After 2 weeks of coffee abstinence (washout), participants who were coffee drinkers were randomly allocated to receive either 4 sachets (1.8g each) of caffeinated instant coffee per day for 3 weeks. Participants were blinded to coffee contents.

Caffeinated coffee

Decaffeinated coffee OTHER

After 2 weeks of coffee abstinence (washout), participants who were coffee drinkers were randomly allocated to receive either 4 sachets (1.8g each) of decaffeinated instant coffee per day for 3 weeks. Participants were blinded to coffee contents.

Decaffeinated coffee

Eligibility Criteria

• Age: 30 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 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

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 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)