Coffee Bioequivalence Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Reading
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Instant coffee given as a drink
Dietary supplementCommercially 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 in a tablet form
Dietary supplementCommercially 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.
Control (placebo)
Dietary supplementA 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.
Treatment groups
16 Participants
are divided into 3 treatment groupsGroup A: Coffee given as a drinkActive comparator 1 intervention
Group B: Coffee given in tablet formActive comparator 1 intervention
Group C: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.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), area under the concentration curve will be calculated.
Time frame
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
1
Fasting concentrations of total cholesterol and high-density lipoprotein cholesterol.
Serum lipids will be measured directly using a clinical chemistry analyser.
Time frame
Acute study days prior to the intervention (0 minutes).2
Fasting and postprandial lipids concentrations after consuming the coffee drink, coffee tablet and control interventions
Serum triacylglycerol and non-esterified fatty acids will be measured in the fasting and postprandial blood samples collected for 480 min after each intervention.
Time frame
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.3
Fasting and postprandial glucose concentrations after consuming the coffee drink, coffee tablet and control interventions
Serum glucose will be measured in the acute study day blood samples collected for 480 minutes after each intervention using a clinical chemistry analyser.
Time frame
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.4
Fasting and postprandial insulin concentrations after consuming the coffee drink, coffee tablet and control interventions
Serum insulin will be measured in the acute study day blood samples collected for 480 minutes after each intervention using an enzyme-lined immunosorbent assay.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov
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