Coffee Intake Biomarker Validation and Association With Respiratory Diseases

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coffee

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saw Swee Hock School of Public Health, National University of Singapore

Singapore, 117549

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Regular coffee drinkers aged 21-64 years old, Chinese ethnicity

Exclusion criteria

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
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

Treatment and study plan

Coffee A

Dietary 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 B

Dietary Supplement

Week 7: coffee B ≤40 g coffee powder for high dose Week 8: non-coffee consumption (post-consumption kinetics)

Tea

Dietary Supplement

Week 9: washout Week 10: tea (control) Week 11: non-coffee consumption (post-consumption kinetics)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2026
First posted: Feb 6, 2026
Registry last updated: Feb 6, 2026

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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