An interventional study of Instant coffee given as a drink and Coffee given in a tablet form in Liver Functions, Bioequivalence and Cardiovascular Risk, sponsored by University of Reading. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University of Reading · Not applicable, Interventional, and Prevention
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:
Participants will:
Coffee has gained interest for its role in the prevention of non-communicable diseases such as heart and liver diseases. Population-based studies have reported that consuming 2-4 cups of coffee per day is associated with lower death rates and, notably reductions in the incidence of heart disease. However, these observational trials do not directly prove causality and carefully designed randomised controlled trials are needed.
This current trial will provide vital information to inform a large-scale randomised controlled trial assessing the effects of coffee consumption on risk markers for developing cardiometabolic disease (such as type 2 diabetes, heart and liver diseases) to test causality. In this follow-up trial to be conducted in 2025, non-coffee consumers will be recruited. To maximise recruitment, retention and adherence in the trial, we are considering providing instant coffee as tablets rather than as a drink. Hence, the current study will help to understand if coffee delivered in a tablet is biologically equivalent to consuming coffee as a drink.
A 3 armed, randomised, controlled crossover trial in healthy participants wil be performed. The primary outcome is the pharmacokinetic profile of coffee bioactives in coffee drink versus the coffee tablet. Secondary outcomes will be assessing the impact of the coffee both as a drink and tablet on cardiovascular and liver health markers (versus a coffee-free control).
Briefly, participants will attend three study phases. Each study phase includes a 480 minute (8-hour) acute postprandial visit and a shorter visit (\~one hour) the following morning. On the first day participants will arrive having fasted overnight and having followed dietary and lifestyle restrictions in the preceding days. They will have baseline anthropometric measures performed and a cannula will be inserted; two baseline blood samples will be collected (14 mL in total). Blood samples will be collected regularly from the cannula, and a clinic blood pressure measurement will be performed at regular intervals following the intervention (a different intervention will be given in a random order at each of the three phases). A breakfast meal and lunch will be provided to the participants during the visit and participants will leave with a standardised meal and snack to consume in the evening. They will return, fasted the following morning to provide a blood samples and have their blood pressure measured. Participants will be asked to collect their urine for 24h following the intervention; this will be returned that morning. There will be a 4-week period between each study phase.
University of Reading is the lead sponsor of 146 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
The caffeine free coffee control will be provided as 4 tablets given with 400 ml of water.
Dietary Supplement: Control (placebo)
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.
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.
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.
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.
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.
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).
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.
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.
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.
Fasting and postprandial liver enzyme concentrations after consuming the coffee drink, coffee tablet and control interventions
Serum alanine transaminase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and glutamate dehydrogenase (GLDH) 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.
Fasting and postprandial gut hormone concentrations after consuming the coffee drink, coffee tablet and control interventions
C-peptide, GIP, GLP-1 and Ghrelin will be measured in the postprandial blood samples collected for 480 min after each interventions.
Time frame: Acute study days, blood taken prior to the intervention (0 minutes) and then 30, 60, 120, 180, 240, 300, 360 and 480 minutes.
Fasting and postprandial plasma metabolomics after consuming the coffee drink, coffee tablet and control interventions
Metabolomics will be measured in the postprandial blood samples collected for 480 min after the interventions using NMR.
Time frame: Acute study days, blood taken prior to the intervention (0 minutes) and then 30, 60, 120, 180, 240, 300, 360, 420 and 480 minutes.
Fasting and postprandial plasma nitrate and nitrite concentrations after consuming the coffee drink, coffee tablet and control interventions
Nitrate, nitrite and Nox (sum of nitrate and nitrite) will be measured in the 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, 120, 180, 240, 300, 360, 420 and 480 minutes.
Urinary metabolomics
Metabolomics will be performed on the 24 h urine samples using NMR .
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary creatinine
Creatinine will be measured in the 24 h urine samples using a clinical chemistry analyser.
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary osmolality and pH
Osmolality will be determined as a measure of the concentration of solutes in the 24 h urine sample and pH to indicate whether the sample is acidic or alkaline after consuming the study interventions.
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary sodium and potassium
Sodium and potassium will be determined in the 24 h urine sample as a marker of kidney function and a nutritional biomarker after consuming the study interventions.
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Body weight
Body weight will be measured using a Tanita scale.
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Height
Height will be measured to the nearest cm using a stadiometer
Time frame: First acute study visit (0 minutes on visit 1)
Blood pressure
Blood pressure will be measured using blood pressure monitor.
Time frame: -15, 30, 60, 120, 180, 240, 300, 360, 420, 480 minutes
Body fat percentage
Body fat percentage will be measured using the Tanita scale by bioelectrical impedance.
Time frame: Each acute study visit (0 minutes)
Body fat mass
Body fat mass will be measured using a Tanita scale.
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Body lean mass
Body lean mass will be measured using a Tanita scale.
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Body mass index
Body mass index will be calculated using the body weight (kg) and height (m) data.
Time frame: On each acute study visit (0 minutes)
Waist and hip circumferences
A non-stretch tape will be used to measure waist and hip circumferences
Time frame: On each acute study visit (0 minutes).
Habitual dietary intake of the study participants
Record of the food and drink prior to the first study visit
Time frame: Two weeks prior to the first acute study visit (t- 2 weeks from visit 1).
Fasting estimate of insulin resistance and insulin sensitivity
HOMA-IR (Homeostasis model assessment estimated insulin resistance) and QUICKI (Quantitative Insulin Sensitivity Check Index) will be calculated using the fasting glucose and insulin data.
Time frame: On each acute study visit (0 minutes).
Fasting low-density lipoprotein-cholesterol concentration
The low-density lipoprotein-cholesterol concentration will be calculated from aforementioned outcomes using the Friedewald formula.
Time frame: On each acute study visit (0 minutes).
Plan to share: Yes — All anonymised IPD that underlie the results in a publication and analytical code for the statistical analysis
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Reading