NCT07051291

Brief Summary

This study is designed to evaluate the acute effect of consuming a cup of instant coffee on circulating metabolites and to evaluate whether ingestion of instant coffee in the form of a capsule has a similar effect on circulating metabolites as compared to the conventionally prepared beverage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

18 days

First QC Date

June 1, 2025

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Caffeine and polyphenol metabolites

    Each participant underwent two interventions, and blood was collected pre- and post- each intervention. Blood was allowed to clot at room temperature. After 30-40 min, serum was separated from entire blood by centrifugation (3000g, 15 min, 4°C) and aliquoted into tubes. All samples were processed on the same day of collection. A total of 7 biomarker compounds (trigonelline, paraxanthine, theophylline, theobromine, caffeine, cyclo(Leu-Pro), and cyclo(Pro-Val)) were quantified using a targeted method developed in-house. The quantification method was optimized by LC retention elution, parent-daughter quantifier mass transitions, and varying MS cone and collision energies (in V) to obtain clear peak separation and height. Multiple Reaction Monitoring (MRM) in positive electrospray ionization mode was performed on a Waters Xevo TQ-S Triple Quadrupole Mass Spectrometer system.

    The period between the two study visits ranged between 7 to 28 days.

Study Arms (2)

Instant coffee capsule/ coffee beverage

EXPERIMENTAL
Dietary Supplement: Instant Coffee CapsuleDietary Supplement: Instant Coffee Beverage

Instant coffee beverage/ coffee capsule

EXPERIMENTAL
Dietary Supplement: Instant Coffee CapsuleDietary Supplement: Instant Coffee Beverage

Interventions

Instant Coffee CapsuleDIETARY_SUPPLEMENT

Participants received 1.7 grams of instant coffee in the form of three capsules. 200 mL of plain water was provided to participants to swallow the three capsules.

Instant coffee beverage/ coffee capsuleInstant coffee capsule/ coffee beverage
Instant Coffee BeverageDIETARY_SUPPLEMENT

Dissolved 1.7 grams of instant coffee in 200 mL of hot water to make a coffee beverage.

Instant coffee beverage/ coffee capsuleInstant coffee capsule/ coffee beverage

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Pregnant or breastfeeding
  • Certain medications including Zanaflex, Sirasalud, Ketanest S, Spravato and Ephedrine Sulfate
  • Any pre-existing medical conditions, depression, anxiety, caffeine/lactose intolerant, fear of needles and/or blood disorders, allergy to coffee or bovine capsules
  • Existing dietary restrictions which makes them unable to consume non-halal certified bovine gelatin (the capsule encasing the coffee powder)
  • Recent history of major surgical operations in the past year
  • 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 both study visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Singapore, 117549, Singapore

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will receive both interventions (instant coffee capsule and instant coffee beverage) in a randomized order across two visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2025

First Posted

July 4, 2025

Study Start

September 22, 2020

Primary Completion

October 10, 2020

Study Completion

October 10, 2022

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations