Clinical trial NCT05927103: Differences Between Coffee and Non-coffee Drinkers in the Gut Microbiome and Microbiota-Gut-Brain Axis
Official title: Differences Between Coffee and Non-coffee Drinkers in the Gut Microbiome and Microbiota-Gut-Brain Axis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Coffee
Microbiome-gut-brain-axis
Stress
Polyphenols
Cognition
Microbiota
Mood
Behaviour
Inflammation
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers between 30 and 50 years old.

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.

Detailed description: 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 in moderate coffee drinkers compared to non-coffee drinkers healthy adults. Reaction time, socioemotional processing, visual and episodic memory, learning, and an attentional task were administered to measure cognitive performance. Self-report questionnaires on mood, behavior and lifestyle were administered and response to an acute stressor was assessed. Biological samples of saliva, urine, blood, and stool were collected to investigate microbiome-gut-brain-axis signaling such as inflammation, short chain fatty acids and other metabolites production and physiological stress.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Are less than 30 and greater than 50 years of age.
2. 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,
3. 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.
4. Be hypertensive.
5. 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.
6. Females who are pregnant or planning a pregnancy, or lactating.
7. Participants who are not fluent in English.
8. Participants who have dyslexia or dyscalculia.
9. Are a current habitual daily smoker.
10. 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.
11. 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.
12. Have a malignant disease or any concomitant end-stage organ disease.
13. Have already done a study in the lab in the past 4 years

Primary outcomes:
measure: Gut Microbiota composition
timeFrame: Difference between the groups at baseline.
Secondary outcomes:
measure: Gut microbial metabolites (including Short-Chain fatty acids)
timeFrame: Difference between the groups at baseline.
measure: Coffee-related metabolites
timeFrame: Difference between the groups at baseline.
Other outcomes:
measure: Cognitive performance: attention
timeFrame: Difference between the groups at baseline.
measure: Cognitive performance - Episodic memory
timeFrame: Difference between the groups at baseline.
measure: Cognitive performance - Learning and visual memory
timeFrame: Difference between the groups at baseline.
measure: Cognitive performance - Processing speed
timeFrame: Difference between the groups at baseline.
measure: Cognitive performance - socioemotional processing
timeFrame: Difference between the groups at baseline.
measure: Responses to acute stressor
timeFrame: Difference between the groups at baseline.
measure: Inflammatory profile
timeFrame: Difference between the groups at baseline.
measure: Cortisol awakening response
timeFrame: Difference between the groups at baseline.
measure: Self-reported questionnaires
timeFrame: Difference between the groups at baseline.
measure: Genotyping adenosine receptor A2A
timeFrame: Difference between the groups at baseline.
Locations:
city: Cork
country: Ireland
facility: University College Cork
Study officials:
affiliation: UCC
name: John F Cryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: