Coffee Bioequivalence Trial

NCT06758531 | Not Yet Recruiting

• 1 other identifier: 24/28
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coffee; Bioequivalence; Caffeine; Liver function; Polyphenols; Blood pressure; Cardiovascular disease; Chlorogenic acids

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic profile of key coffee biologically active compounds and their metabolites after consuming a coffee drink, a coffee tablet and control.

  Key coffee biologically active compounds and their metabolites (e.g. chlorogenic acids, caffeine, trigonelline) will be measured in plasma samples collected over a 24 h period after each intervention. The pharmacokinetic profile (absorption, metabolism and excretion), maximal concentration, Cmax will be calculated.

  Blood taken prior to consuming the intervention (0 minutes) and then 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 and 1440 minutes post intervention.

• Pharmacokinetic profile of key coffee biologically active compounds and their metabolites after consuming a coffee drink, a coffee tablet and control.

  Key coffee biologically active compounds and their metabolites (e.g. chlorogenic acids, caffeine, trigonelline) will be measured in plasma samples collected over a 24 h period after each intervention. The pharmacokinetic profile (absorption, metabolism and excretion), area under the concentration curve will be calculated.

  Blood taken prior to consuming the intervention (0 minutes) and then 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 and 1440 minutes post intervention.

Secondary Outcomes (23)

• Fasting concentrations of total cholesterol and high-density lipoprotein cholesterol.

  Acute study days prior to the intervention (0 minutes).

• Fasting and postprandial lipids concentrations after consuming the coffee drink, coffee tablet and control interventions

  Acute study days, blood taken prior to the intervention (0 minutes) and then 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes.

• Fasting and postprandial glucose concentrations after consuming the coffee drink, coffee tablet and control interventions

  Acute study days, blood taken prior to consuming the intervention (0 minutes) and then 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes.

• Fasting and postprandial insulin concentrations after consuming the coffee drink, coffee tablet and control interventions

  Acute study days, blood taken prior to consuming the intervention (0 minutes) and then 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes.

• Fasting and postprandial liver enzyme concentrations after consuming the coffee drink, coffee tablet and control interventions

  Acute study days, blood taken prior to consuming the intervention (0 minutes) and then 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes.

Study Arms (3)

Coffee given as a drink

ACTIVE COMPARATOR

This group will consume 3.6 g of commercially available instant coffee given as a drink prepared with 400 ml of water.

Dietary Supplement: Instant coffee given as a drink

Coffee given in tablet form

ACTIVE COMPARATOR

This group will receive 3.6 g of instant coffee provided as 4 tablets consumed with 400 ml of water.

Dietary Supplement: Coffee given in a tablet form

Control group

PLACEBO COMPARATOR

The caffeine free coffee control will be provided as 4 tablets given with 400 ml of water.

Dietary Supplement: Control (placebo)

Interventions

Instant coffee given as a drink DIETARY_SUPPLEMENT

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.

Coffee given as a drink

Coffee given in a tablet form DIETARY_SUPPLEMENT

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.

Coffee given in tablet form

Control (placebo) DIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and pre-menopausal females (must have regular menstrual cycles)
• Aged between 18 to 45 years
• Body mass index (BMI) between 18.5-30 kg/m2

You may not qualify if:

• Sensitivity to coffee and caffeine
• Food allergies relating to the test meals provided (such as gluten or lactose intolerance)
• Current smoking and vaping use.
• Medical history of chronic diseases (cancer, high blood pressure (hypertension), type 2 diabetes, heart attack and/or any other heart disease related diseases, gastrointestinal disorders, hyperlipidaemia, kidney or liver disease).
• Diagnosed with anaemia
• Prescribed any medication relating to the study outcome measures (such as blood pressure lowering, anti-inflammatories or blood thinners).
• Drinking more than the recommended intake for alcohol (\> 14 units/week)
• Taking any supplements (vitamins, minerals, probiotics).
• Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study (e.g. pacemaker)
• Planning on a weight-reducing regimen (lost \>3 kg in the last 6 months)
• Parallel participation in another intervention study
• Pregnancy, planning a pregnancy in the next 6 months or breastfeeding
• NHS blood donation in the last 3 months

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Abbe Davy, BSc

  University of Reading

  STUDY DIRECTOR

Central Study Contacts

Charlotte E Mills, PhD

CONTACT

0118378; c.e.mills@reading.ac.uk

Kim G Jackson, PhD

CONTACT

0118378; k.g.jackson@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Sinclair Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Anonymised data will be made available on reasonable request to the study Chief Investigator one year after manuscripts have been published.
• Access Criteria: For data sharing and preservation, anonymised IPD will be archived in the University of Reading Research Data Archive. Access will be overseen by the project Chief Investigator (Dr Charlotte Mills).

Locations

GB (1)