CoffeeNCT07391696
Coffee Intake Biomarker Validation and Association With Respiratory Diseases
A study testing Coffee A, Coffee B and Tea in people with Coffee, run by National University of Singapore at 1 site in Singapore.
Trial summary
This proposed project aims to identify and validate biomarkers of coffee exposure in the Singapore population, and assess the association between coffee consumption (via biomarker measurements) and risk of respiratory diseases in a prospective multi-ethnic cohort in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Coffee
- What is being tested?
- Coffee A, Coffee B and Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular coffee drinkers aged 21-64 years old, Chinese ethnicity
Who cannot join
- Healthy individuals who are regular coffee and/or tea drinkers, aged 21-64 years old of Chinese ethnicity with no severe medical conditions and are physically-abled, can participate in the research. However, you cannot participate in or will be released from this study if the following conditions or situations apply to you:
- Ineligible screening survey which will consist of basic demographic information and questions pertaining to inclusion/exclusion criteria such as age, gender, current medications, chronic illness, etc
- Dislike drinking coffee and tea
- Pregnant or breastfeeding
- Certain medications including Zanaflex, Sirasalud, Ketanest S, Spravato and Ephedrine Sulfate (See full list of medication)
- Present medical conditions: cancer, cardiometabolic diseases, endocrine diseases, depression, anxiety, caffeine/lactose intolerant, fear of needles and/or blood disorders
Show all 12Show fewer
- Recent history of major surgical operations
- Past or current user of oral/systemic hormone treatment or therapies
- Taken antibiotics in the last 3 months
- Taking nutritional supplements (that contains coffee/tea-related compounds naturally found in other plants)
- Not willing to travel to the University for the study
- Unable to commit to completing all the sessions in the 10-week intervention study
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Saw Swee Hock School of Public Health, National University of Singapore
Singapore, Singapore, 117549
About this study
This proposed project aims to identify and validate biomarkers of coffee exposure in the Singapore population, and assess the association between coffee consumption (via biomarker measurements) and risk of respiratory diseases in a prospective multi-ethnic cohort in Singapore.
Specific Aim 1: To identify and quantify urinary/serum metabolite changes that are associated with coffee consumption in a dose-response intervention study.
- Conditions
- Coffee
- Being tested
- Coffee A, Coffee B, Tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee ADietary supplement
Week 1: coffee A ≤10 g coffee powder for low dose Week 2: non-coffee consumption (post-consumption kinetics) Week 3: coffee A ≤20 g coffee powder for medium dose Week 4: non-coffee consumption (post-consumption kinetics) Week 5: coffee A ≤40 g coffee powder for high dose Week 6: non-coffee consumption (post-consumption kinetics)
Coffee BDietary supplement
Week 7: coffee B ≤40 g coffee powder for high dose Week 8: non-coffee consumption (post-consumption kinetics)
TeaDietary supplement
Week 9: washout Week 10: tea (control) Week 11: non-coffee consumption (post-consumption kinetics)
| Study group | Role | What they receive |
|---|---|---|
| Coffee Dose-Response Intervention | Experimental | Participants receive sequential dietary interventions with Coffee A, Coffee B/C, and Tea A across 12 weeks, interspersed with washout periods. Biological samples and dietary records are collected throughout. Receives: Dietary Supplement: Coffee A; Dietary Supplement: Coffee B; Dietary Supplement: Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary and serum metabolite changes associated with coffee consumption
Urine and serum samples will undergo a combination of targeted and untargeted metabolomic profiling at the Singapore Phenome Centre located at NTU. Briefly, thawed urine, serum, coffee and tea samples will be analysed directly on the UHPLC-TQ-MS. Secondly, to explore potentially novel biomarkers and/or metabolites related to the consumption of the two types of coffee relevant to Singapore (black coffee and coffee with additives), untargeted metabolomics will be conducted on the urine and serum samples.
Measured: 12week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoffeeStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seow Wei Jie, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391696
- Sponsor's protocol ID
- NUS-IRB-2022-414
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 6 Feb 2026
- Results posted
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Intake Biomarker Validation and Association With Respiratory Diseases
- ClinicalTrials.gov ID
- NCT07391696
- Acronym / sponsor ID
- NUS-IRB-2022-414
- Conditions
- Coffee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
This proposed project aims to identify and validate biomarkers of coffee exposure in the Singapore population, and assess the association between coffee consumption (via biomarker measurements) and risk of respiratory diseases in a prospective multi-ethnic cohort in Singapore.
Specific Aim 1: To identify and quantify urinary/serum metabolite changes that are associated with coffee consumption in a dose-response intervention study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coffee Dose-Response Intervention | Experimental | Dietary Supplement: Coffee A, Dietary Supplement: Coffee B, Dietary Supplement: TeaParticipants receive sequential dietary interventions with Coffee A, Coffee B/C, and Tea A across 12 weeks, interspersed with washout periods. Biological samples and dietary records are collected throughout. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Regular coffee drinkers aged 21-64 years old, Chinese ethnicity
Key exclusion criteria (12 listed)
- Healthy individuals who are regular coffee and/or tea drinkers, aged 21-64 years old of Chinese ethnicity with no severe medical conditions and are physically-abled, can participate in the research. However, you cannot participate in or will be released from this study if the following conditions or situations apply to you:
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 |
|---|---|---|
| Coffee AWeek 1: coffee A ≤10 g coffee powder for low dose Week 2: non-coffee consumption (post-consumption kinetics) Week 3: coffee A ≤20 g coffee powder for medium dose Week 4: non-coffee consumption (post-consumption kinetics) Week 5: coffee A ≤40 g coffee powder for high dose Week 6: non-coffee consumption (post-consumption kinetics) | Dietary supplement | Coffee Dose-Response Intervention |
| Coffee BWeek 7: coffee B ≤40 g coffee powder for high dose Week 8: non-coffee consumption (post-consumption kinetics) | Dietary supplement | Coffee Dose-Response Intervention |
| TeaWeek 9: washout Week 10: tea (control) Week 11: non-coffee consumption (post-consumption kinetics) | Dietary supplement | Coffee Dose-Response Intervention |
Primary outcome
Urinary and serum metabolite changes associated with coffee consumption
Time frame: 12week
Urine and serum samples will undergo a combination of targeted and untargeted metabolomic profiling at the Singapore Phenome Centre located at NTU. Briefly, thawed urine, serum, coffee and tea samples will be analysed directly on the UHPLC-TQ-MS. Secondly, to explore potentially novel biomarkers and/or metabolites related to the consumption of the two types of coffee relevant to Singapore (black coffee and coffee with additives), untargeted metabolomics will be conducted on the urine and serum samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee A, Coffee B and Tea in people with Coffee, run by National University of Singapore at 1 site in Singapore.
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 1 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Urinary and serum metabolite changes associated with coffee consumption (time frame: 12week). 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 6 Feb 2026.