Coffee Intake Biomarker Validation and Association With Respiratory Diseases

NCT07391696 | Active Not Recruiting

• 1 other identifier: NUS-IRB-2022-414
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12week

Study Arms (1)

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.

Dietary Supplement: Coffee A; Dietary Supplement: Coffee B; Dietary Supplement: Tea

Interventions

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 Dose-Response Intervention

Coffee B DIETARY_SUPPLEMENT

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

Coffee Dose-Response Intervention

Tea DIETARY_SUPPLEMENT

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

Coffee Dose-Response Intervention

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

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

Singapore, Singapore, 117549, Singapore

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: February 6, 2026
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)