HealthyNCT05757154
Coffee for Optimal Metabolite Profile
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The aim of this project is to evaluate metabolite profile after consumption of three types of coffee differing in type of bean, degree of roasting and preparation method. Metabolite profiles will be evaluated after a) a single dose b) 3-day consumption. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2023to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males
- 18 to 80 years of age
- Body mass index (BMI) 18.5-30.0 kg/m2
- Fasting glucose ≤ 6.1 mmol/l
- Low density lipoprotein (LDL) cholesterol ≤ 5.30 mmol/l
- Triglycerides ≤ 2.60 mmol/l
- Signed informed consent
Who cannot join
- Food allergies or intolerances preventing consumption of any products included in the study.
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personnel.
- Pregnant, lactating or planning a pregnancy during the study period.
- Antibiotic use for the last 3 months.
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Chron's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
Show all 9Show fewer
- Previous major gastrointestinal surgery
- Have type I diabetes
- Thyroid disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg
About this study
The aim of this project is to evaluate metabolite profile after consumption of three types of coffee differing in type of bean, degree of roasting and preparation method. Metabolite profiles will be evaluated after a) a single dose b) 3-day consumption. The study will be carried out as a three-way cross-over design with three different types of coffee. Wash-out periods where participants consume their habitual diet are implemented between all intervention periods. The first day of intervention (single dose) includes postprandial measurements during 13 hours.
- Conditions
- Healthy
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.
| Study group | Role | What they receive |
|---|---|---|
| Coffee A | Experimental | Coffee type A. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. Receives: Other: Diet |
| Coffee B | Experimental | Coffee type B. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. Receives: Other: Diet |
| Coffee C | Experimental | Coffe type C. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Measured: 24 hours
Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Difference in plasma AUC between the different types of coffee for each biomarker candidate.
Measured: 24 hours
Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Measured: 24 hours
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Cmax will be estimated.
Measured: 24 hours
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Tmax will be estimated.
Measured: 24 hours
Secondary outcomes (6)
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.
Measured: 4 days
Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.
Measured: 4 days
Plasma metabolites
Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect coffee consumption. Baseline compared with after intervention products.
Measured: 4 days
Urine metabolites
Untargeted metabolomics will be performed using established methods for urine. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect coffee consumption. Baseline compared with after intervention products.
Measured: 24 hours
Gut microbiome
Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention products.
Measured: 4 days
Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Evaluate new simple sampling techniques using dried blood spots.
Measured: 13 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start31 Mar 2023
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Paulig Group
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757154
- Sponsor's protocol ID
- ChalmersUA
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee for Optimal Metabolite Profile
- ClinicalTrials.gov ID
- NCT05757154
- Acronym / sponsor ID
- ChalmersUA
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Paulig Group
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 7 Mar 2023 (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 aim of this project is to evaluate metabolite profile after consumption of three types of coffee differing in type of bean, degree of roasting and preparation method. Metabolite profiles will be evaluated after a) a single dose b) 3-day consumption. The study will be carried out as a three-way cross-over design with three different types of coffee. Wash-out periods where participants consume their habitual diet are implemented between all intervention periods. The first day of intervention (single dose) includes postprandial measurements during 13 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coffee A | Experimental | Other: DietCoffee type A. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. |
| Coffee B | Experimental | Other: DietCoffee type B. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. |
| Coffee C | Experimental | Other: DietCoffe type C. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females and males
- 18 to 80 years of age
- Body mass index (BMI) 18.5-30.0 kg/m2
- Fasting glucose ≤ 6.1 mmol/l
- Low density lipoprotein (LDL) cholesterol ≤ 5.30 mmol/l
Key exclusion criteria (9 listed)
- Food allergies or intolerances preventing consumption of any products included in the study.
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personnel.
- Pregnant, lactating or planning a pregnancy during the study period.
- Antibiotic use for the last 3 months.
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
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 |
|---|---|---|
| DietAll intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method. | Other | Coffee A, Coffee B, Coffee C |
Primary outcome
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 24 hours
Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 24 hours
Difference in plasma AUC between the different types of coffee for each biomarker candidate.
Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 24 hours
Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 24 hours
Cmax will be estimated.
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 24 hours
Tmax will be estimated.
6 secondary outcomes
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 4 days
Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 4 days
Plasma metabolites
Time frame: 4 days
Urine metabolites
Time frame: 24 hours
Gut microbiome
Time frame: 4 days
Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time frame: 13 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rikard Landberg, Dr principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 22 Aug 2023. 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 Sweden. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes. (time frame: 24 hours). The study lists 5 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 22 Aug 2023.