Liver FunctionsNCT06758531
Coffee Bioequivalence Trial
A study testing Instant coffee given as a drink and Coffee given in a tablet form in people with Liver Functions and Bioequivalence, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Functions, Bioequivalence, Cardiovascular Risk
- What is being tested?
- Instant coffee given as a drink and Coffee given in a tablet form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6DZ
Hugh Sinclair Manager, 0118378 ext. 7771, nutritionvolunteers@reading.ac.uk
Charlotte E Mills, PhD
About this study
Official title: Coffee Bioequivalence Trial: Comparing the Pharmacokinetics of Bioactive Components and Physiological Effects of Consuming Encapsulated Instant Coffee Versus Traditional Instant Coffee Brewed in Water
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?
Read more
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).
Read the detailed description
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.
- Being tested
- Instant coffee given as a drink, Coffee given in a tablet form, Control (placebo)
- Keywords
- Coffee, Bioequivalence, Caffeine, Liver function, Polyphenols, Blood pressure, Cardiovascular disease, Chlorogenic acids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instant coffee given as a drinkDietary 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 in a tablet formDietary 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Control (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Serum lipids will be measured directly using a clinical chemistry analyser.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: First acute study visit (0 minutes on visit 1)
Blood pressure
Blood pressure will be measured using blood pressure monitor.
Measured: -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.
Measured: Each acute study visit (0 minutes)
Body fat mass
Body fat mass will be measured using a Tanita scale.
Measured: 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.
Measured: 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.
Measured: On each acute study visit (0 minutes)
Waist and hip circumferences
A non-stretch tape will be used to measure waist and hip circumferences
Measured: 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
Measured: 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.
Measured: 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.
Measured: On each acute study visit (0 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte E Mills, University of Reading
- Investigators
- Abbe Davy, BSc, Study director, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758531
- Sponsor's protocol ID
- 24/28
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised IPD that underlie the results in a publication and analytical code for the statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Bioequivalence Trial: Comparing the Pharmacokinetics of Bioactive Components and Physiological Effects of Consuming Encapsulated Instant Coffee Versus Traditional Instant Coffee Brewed in Water
- ClinicalTrials.gov ID
- NCT06758531
- Acronym / sponsor ID
- 24/28
- Keywords
- Coffee, Bioequivalence, Caffeine, Liver function, Polyphenols, Blood pressure, Cardiovascular disease, Chlorogenic acids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee given as a drink | Active comparator | Dietary Supplement: Instant coffee given as a drinkThis group will consume 3.6 g of commercially available instant coffee given as a drink prepared with 400 ml of water. |
| Coffee given in tablet form | Active comparator | Dietary Supplement: Coffee given in a tablet formThis group will receive 3.6 g of instant coffee provided as 4 tablets consumed with 400 ml of water. |
| Control group | Placebo comparator | Dietary Supplement: Control (placebo)The caffeine free coffee control will be provided as 4 tablets given with 400 ml of water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instant coffee given as a drinkCommercially 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 as a drink |
| Coffee given in a tablet formCommercially 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 | Coffee given in tablet form |
| 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. | Dietary supplement | Control group |
Primary outcome
Pharmacokinetic profile of key coffee biologically active compounds and their metabolites after consuming a coffee drink, a coffee tablet and control.
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.
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.
Pharmacokinetic profile of key coffee biologically active compounds and their metabolites after consuming a coffee drink, a coffee tablet and control.
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.
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.
23 secondary outcomes
Fasting concentrations of total cholesterol and high-density lipoprotein cholesterol.
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
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
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
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
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
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
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
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
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary creatinine
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary osmolality and pH
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Urinary sodium and potassium
Time frame: Urine will be collected prior to (0 minutes) and for 1440 minutes after each intervention.
Body weight
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Height
Time frame: First acute study visit (0 minutes on visit 1)
Blood pressure
Time frame: -15, 30, 60, 120, 180, 240, 300, 360, 420, 480 minutes
Body fat percentage
Time frame: Each acute study visit (0 minutes)
Body fat mass
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Body lean mass
Time frame: On each acute study visit prior to the collection of the first blood sample (0 minutes).
Body mass index
Time frame: On each acute study visit (0 minutes)
Waist and hip circumferences
Time frame: On each acute study visit (0 minutes).
Habitual dietary intake of the study participants
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
Time frame: On each acute study visit (0 minutes).
Fasting low-density lipoprotein-cholesterol concentration
Time frame: On each acute study visit (0 minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Yes. All anonymised IPD that underlie the results in a publication and analytical code for the statistical analysis
Related trials for Liver Functions
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement
Not yet recruitingPhase 1
Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function
Obesity, Overweight, T2DM (Type 2 Diabetes Mellitus)
RecruitingPhase 1
Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
Healthy, Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib
Healthy Participants, Gastrointestinal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abbe Davy, BSc study director
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instant coffee given as a drink and Coffee given in a tablet form in people with Liver Functions and Bioequivalence, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte E Mills, PhD (0118378 ext. 7108, c.e.mills@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of key coffee biologically active compounds and their metabolites after consuming a coffee drink, a coffee tablet and control. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.