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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927103
• Other study ID #: APC115a
• Status: Completed
• Start date: September 21, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: June 2023
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Ireland	University College Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive performance: attention	Assessment of attention using the Paced Auditory Serial Addition Test (PASAT)	Difference between the groups at baseline.
Other	Cognitive performance - Episodic memory	Assessment of episodic memory using the Modified Rey Auditory Verbal Learning Test (ModRey)	Difference between the groups at baseline.
Other	Cognitive performance - Learning and visual memory	Assessment of learning and visual memory using the Paired Associates Learning task	Difference between the groups at baseline.
Other	Cognitive performance - Processing speed	Assessment of processing speed using the Motor Screening Test	Difference between the groups at baseline.
Other	Cognitive performance - socioemotional processing	Assessment of socioemotional processing using the Emotion Recognition Task	Difference between the groups at baseline.
Other	Responses to acute stressor	Self-report mood and cortisol responses to the Socially Evaluated Cold Pressor Test	Difference between the groups at baseline.
Other	Inflammatory profile	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	Difference between the groups at baseline.
Other	Cortisol awakening response	Cortisol awakening response measurement using ELISAs	Difference between the groups at baseline.
Other	Self-reported questionnaires	Completion of self-reported questionnaires on mood, depression, anxiety, impulsivity, emotional reactivity, stress, and sleep quality. Low scores represents better outcomes.	Difference between the groups at baseline.
Other	Genotyping adenosine receptor A2A	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.	Difference between the groups at baseline.
Primary	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	Gut microbial metabolites (including Short-Chain fatty acids)	Untargeted metabolomics of fecal samples	Difference between the groups at baseline.
Secondary	Coffee-related metabolites	Targeted metabolomics of coffee-related metabolomics in fecal and urine samples	Difference between the groups at baseline.