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Coffee Bioequivalence Trial

NCT06758531 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-03

No results posted yet for this study

Summary

The goal of this clinical trial is to test if coffee consumed as a tablet is biologically equivalent to that consumed traditionally as a drink. It will also learn about the impact of the short-term intake of coffee on markers of cardiovascular and liver health. The main questions it aims to answer are:

* Do coffee bioactive compounds produce the same levels in blood and urine regardless of how the coffee is consumed (tablet or drink)?
* How does coffee as a tablet or drink impact cardiovascular risk and liver health versus a non-coffee control?

Participants will:

* Visit the clinical unit for three phases; each phase is 1x 480 minute (eight hour) acute postprandial visit and 1 x one hour visit the following day. During each phase they will be randomly assigned to take a different intervention (coffee drink, coffee tablet, coffee-free control)
* Be cannulated during the 480 minute (8 hour) acute visits and have regular blood draws as well as basic clinical assessments
* Return on day two for a fasting blood sample and basic clinical assessment
* Collect their urine for 24 h
* Be asked to record their intake of foods and drinks for 3 days to assess their usual diet (dietary assessment).

Conditions

  • Liver Functions
  • Bioequivalence
  • Cardiovascular Risk
  • Cardiometabolic Risk Markers

Interventions

DIETARY_SUPPLEMENT

Instant coffee given as a drink

Commercially available instant coffee (3.6 g) will be provided in the form of a drink prepared with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.

DIETARY_SUPPLEMENT

Coffee given in a tablet form

Commercially available instant coffee (3.6 g) will be provided as 4 tablets given with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.

DIETARY_SUPPLEMENT

Control (placebo)

A caffeine and coffee free control (3.6 g) will be provided as 4 tablets given with 400 ml of water. A standard breakfast consisting of cereal with milk will be provided at 60 mins after the intervention. A standard lunch (cheese sandwiches, potato crisps and shortbread biscuits) will be given at 300 after coffee intake.

Sponsors & Collaborators

  • University of Reading

    lead OTHER

Principal Investigators

  • Abbe Davy, BSc · University of Reading

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06758531 on ClinicalTrials.gov