Cardiovascular DiseaseNCT01813981
The Effect of High and Low Roasted Coffee on Vascular Response
A study testing Low roast coffee and High roast coffee in people with Cardiovascular Disease, run by University of Reading at 2 sites in United Kingdom.
Trial summary
Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA), however the level of CGA is reduced during the roasting process. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Low roast coffee and High roast coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2011to Jan 2013
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- A signed consent form
- Age 19-35 years
- Body mass index - 18.5-30 kg/m2
- Normal blood pressure at screening (< 150/90)
Who cannot join
- Blood pressure > 150/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any reproductive disorder
Show all 17Show fewer
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
- Drinking more than 21 units per week
- On any lipid-modifying medication
- On any blood pressure lowering medication
- On any medication affecting blood clotting
- Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
- Regular or vigorous exercise (3 times/week, 20 minutes each session)
- Smoking
- Vegetarians or vegans
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP
University of Reading
Reading, England, RG6 6UR
About this study
Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA), however the level of CGA is reduced during the roasting process.
The aim of this study is to investigate the effect of coffee roasting on vascular response. The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable vascular response over more heavily roasted coffee due to the higher levels of CGA.
- Conditions
- Cardiovascular Disease
- Being tested
- Low roast coffee, High roast coffee, Control (Caffeine dissolved in water)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low roast coffeeDietary supplement
Instant coffee
High roast coffeeDietary supplement
Instant coffee
Control (Caffeine dissolved in water)Dietary supplement
Caffeine dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| High roast coffee | Placebo comparator | 110mg caffeine with 108 mg chlorogenic acid at start of study Receives: Dietary Supplement: Control (Caffeine dissolved in water) |
| Low roast coffee | Active comparator | 110 mg caffeine with 235 mg chlorogenic acid at start of the study Receives: Dietary Supplement: Low roast coffee |
| Control | Placebo comparator | 110 mg caffeine at start of study Receives: Dietary Supplement: High roast coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular response measured by flow mediated dilatation (FMD)
Measured: Change from baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813981
- Sponsor's protocol ID
- COFF2011
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
PubMed 28012692
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High and Low Roasted Coffee on Vascular Response
- ClinicalTrials.gov ID
- NCT01813981
- Acronym / sponsor ID
- COFF2011
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- 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.
Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA), however the level of CGA is reduced during the roasting process.
The aim of this study is to investigate the effect of coffee roasting on vascular response. The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable vascular response over more heavily roasted coffee due to the higher levels of CGA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High roast coffee | Placebo comparator | Dietary Supplement: Control (Caffeine dissolved in water)110mg caffeine with 108 mg chlorogenic acid at start of study |
| Low roast coffee | Active comparator | Dietary Supplement: Low roast coffee110 mg caffeine with 235 mg chlorogenic acid at start of the study |
| Control | Placebo comparator | Dietary Supplement: High roast coffee110 mg caffeine at start of study |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- A signed consent form
- Age 19-35 years
- Body mass index - 18.5-30 kg/m2
- Normal blood pressure at screening (< 150/90)
Key exclusion criteria (17 listed)
- Blood pressure > 150/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
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 |
|---|---|---|
| Low roast coffeeInstant coffee | Dietary supplement | Low roast coffee |
| High roast coffeeInstant coffee | Dietary supplement | Control |
| Control (Caffeine dissolved in water)Caffeine dissolved in water | Dietary supplement | High roast coffee |
Primary outcome
Vascular response measured by flow mediated dilatation (FMD)
Time frame: Change from baseline to 2 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 19 Mar 2013.
- Derived from this study: PubMed 28012692Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
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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.
Jeremy PE Spencer principal investigator
University of Reading
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low roast coffee and High roast coffee in people with Cardiovascular Disease, run by University of Reading at 2 sites 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 5 inclusion and 17 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 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Vascular response measured by flow mediated dilatation (FMD) (time frame: Change from baseline to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01813981, which also lists 1 linked publication.
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 19 Mar 2013.