HealthyNCT05927038
Coffee Consumption, the Gut Microbiome, and the Microbiota-Gut-Brain Axis
A study testing Caffeinated coffee and Decaffeinated coffee in people with Healthy, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeinated coffee and Decaffeinated coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIreland
- Study dates
- 21 Sep 2021to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
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.
Read the 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. Additional gut-brain axis pathways-related parameters such as inflammation, short chain fatty acids and other metabolites production and physiological stress levels will be explored. Moreover, differences between caffeinated and decaffeinated coffee consumption will be investigated to determine whether observed effects are attributed to caffeine or other coffee components.
To determine the mechanism of action underlying the beneficial effects of coffee, coffee drinkers abstained from coffee and caffeine for a 2-week washout period following the baseline visit. Coffee drinkers further underwent an intervention in which they consumed either 4 sachets (1.8 grams each) of instant caffeinated or decaffeinated coffee per day for 3 weeks of using a double-blind, randomised, parallel design. 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.
- Conditions
- Healthy
- Being tested
- Caffeinated coffee, Decaffeinated coffee
- Keywords
- Coffee, Microbiome-gut-brain-axis, Prebiotic, Polyphenol, Cognition, Stress, Mood, Behavior, Inflammation, Gut Microbiota, Caffeine
- Medical subject headings
- Behavior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated coffeeOther
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.
Decaffeinated coffeeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated coffee | Experimental | 4 sachets (1.8 grams each) of instant, caffeinated coffee Receives: Other: Caffeinated coffee |
| Decaffeinated coffee | Experimental | 4 sachets (1.8 grams each) of instant, decaffeinated coffee Receives: Other: Decaffeinated coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition and function
Shotgun metagenomics of fecal samples
Measured: 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)
Untargeted metabolomics of fecal samples
Measured: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention
Coffee-related metabolites
Targeted metabolomics of coffee-related metabolomics in fecal and urine samples
Measured: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start21 Sep 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F Cryan, PhD, Principal investigator, UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927038
- Sponsor's protocol ID
- APC115
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Consumption, the Gut Microbiome, and the Microbiota-Gut-Brain Axis
- ClinicalTrials.gov ID
- NCT05927038
- Acronym / sponsor ID
- APC115
- Conditions
- Healthy
- Keywords
- Coffee, Microbiome-gut-brain-axis, Prebiotic, Polyphenol, Cognition, Stress, Mood, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Additional gut-brain axis pathways-related parameters such as inflammation, short chain fatty acids and other metabolites production and physiological stress levels will be explored. Moreover, differences between caffeinated and decaffeinated coffee consumption will be investigated to determine whether observed effects are attributed to caffeine or other coffee components.
To determine the mechanism of action underlying the beneficial effects of coffee, coffee drinkers abstained from coffee and caffeine for a 2-week washout period following the baseline visit. Coffee drinkers further underwent an intervention in which they consumed either 4 sachets (1.8 grams each) of instant caffeinated or decaffeinated coffee per day for 3 weeks of using a double-blind, randomised, parallel design. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeinated coffee | Experimental | Other: Caffeinated coffee4 sachets (1.8 grams each) of instant, caffeinated coffee |
| Decaffeinated coffee | Experimental | Other: Decaffeinated coffee4 sachets (1.8 grams each) of instant, decaffeinated coffee |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated coffeeAfter 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. | Other | Caffeinated coffee |
| Decaffeinated coffeeAfter 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. | Other | Decaffeinated coffee |
Primary outcome
Microbiota composition and function
Time frame: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention
Shotgun metagenomics of fecal samples
2 secondary outcomes
Gut microbial metabolites (including Short-Chain fatty acids)
Time frame: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention
Coffee-related metabolites
Time frame: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Cryan, PhD principal investigator
UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated coffee and Decaffeinated coffee in people with Healthy, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition and function (time frame: Differences between groups at baseline, at 2-week coffee abstinence and at 3-week coffee intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.