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Completed

NCT Number: NCT05927103

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

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University College Cork

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Gut Microbiota composition

    Time frame: Difference between the groups at baseline.

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

Secondary outcomes

  1. Gut microbial metabolites (including Short-Chain fatty acids)

    Time frame: Difference between the groups at baseline.

    Untargeted metabolomics of fecal samples

  2. Coffee-related metabolites

    Time frame: Difference between the groups at baseline.

    Targeted metabolomics of coffee-related metabolomics in fecal and urine samples

Other outcomes

  1. Cognitive performance: attention

    Time frame: Difference between the groups at baseline.

    Assessment of attention using the Paced Auditory Serial Addition Test (PASAT)

  2. Cognitive performance - Episodic memory

    Time frame: Difference between the groups at baseline.

    Assessment of episodic memory using the Modified Rey Auditory Verbal Learning Test (ModRey)

  3. Cognitive performance - Learning and visual memory

    Time frame: Difference between the groups at baseline.

    Assessment of learning and visual memory using the Paired Associates Learning task

  4. Cognitive performance - Processing speed

    Time frame: Difference between the groups at baseline.

    Assessment of processing speed using the Motor Screening Test

  5. Cognitive performance - socioemotional processing

    Time frame: Difference between the groups at baseline.

    Assessment of socioemotional processing using the Emotion Recognition Task

  6. Responses to acute stressor

    Time frame: Difference between the groups at baseline.

    Self-report mood and cortisol responses to the Socially Evaluated Cold Pressor Test

  7. Inflammatory profile

    Time frame: Difference between the groups at baseline.

    Inflammatory markers analysis in LPS-stimulated blood and in the plasma using MSD multiplex technology. The inflammatory markers analyzed were: C-reactive protein, IL6,IL10,IL8, INFgamma, TNFalpha, IL1beta

  8. Cortisol awakening response

    Time frame: Difference between the groups at baseline.

    Cortisol awakening response measurement using ELISAs

  9. Self-reported questionnaires

    Time frame: Difference between the groups at baseline.

    Completion of self-reported questionnaires on mood, depression, anxiety, impulsivity, emotional reactivity, stress, and sleep quality. Low scores represents better outcomes.

  10. Genotyping adenosine receptor A2A

    Time frame: Difference between the groups at baseline.

    Genotyping of 2 SNPs (specifically rs5575187 and rs2298383) of the A2A receptor (ADORA2A) from blood using I-PLEX golden chemistry, Mass array, Mass spectrometry system.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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