Influence of Espresso on Heart Rate VariabilityNCT00576030
Action of Caffeinated and Decaffeinated Espresso on Autonomic Function
A study testing hab cof with water, hab cof with dec espresso and hab cof with caf espresso in people with Influence of Espresso on Heart Rate Variability, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee. In our study we aim to test the following hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influence of Espresso on Heart Rate Variability
- What is being tested?
- hab cof with water, hab cof with dec espresso and hab cof with caf espresso
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Oct 2008
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18- 50 years old, healthy
Who cannot join
- Medication, obese(BMI > 30)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychosomatic Medicine and Psychotherapy, Charité University
Berlin
About this study
Official title: Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals
More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee.
In our study we aim to test the following hypotheses:
- Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart.
- Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure. The heart rate variability and the parasympathetic activity of the heart will decrease.
- Caffeinated or decaffeinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.
- Being tested
- hab cof with water, hab cof with dec espresso, hab cof with caf espresso, non-hab cof with water, non-hab cof with dec espresso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hab cof with waterOther
habitual coffee drinker provided with water
hab cof with dec espressoOther
habitual coffee drinkers given decaffeinated espresso
hab cof with caf espressoOther
habitual coffee drinkers given caffeinated espresso
non-hab cof with waterOther
non-habitual coffee drinkers given water
non-hab cof with dec espressoOther
non-habitual coffee drinkers given decaffeinated espresso
non-hab cof with caf espressoOther
non-habitual coffee drinkers given caffeinated espresso
| Study group | Role | What they receive |
|---|---|---|
| H | Other | habitual coffee drinkers Receives: Other: hab cof with water; Other: hab cof with dec espresso; Other: hab cof with caf espresso |
| N | Other | non-habitual coffee drinkers Receives: Other: non-hab cof with water; Other: non-hab cof with dec espresso; Other: non-hab cof with caf espresso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: 70 minutes
Secondary outcomes (1)
blood pressure
Measured: 70 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influence of Espresso on Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576030
- Sponsor's protocol ID
- EA4/061/06
- Other IDs
- EA4/061/06
- Status last verified
- Aug 2009
- First submitted
- 14 Dec 2007
- Last updated
- 5 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals
- ClinicalTrials.gov ID
- NCT00576030
- Acronym / sponsor ID
- EA4/061/06
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Dec 2007 (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.
More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee.
In our study we aim to test the following hypotheses:
- Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart.
- Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure. The heart rate variability and the parasympathetic activity of the heart will decrease.
- Caffeinated or decaffeinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H | Other | Other: hab cof with water, Other: hab cof with dec espresso, Other: hab cof with caf espressohabitual coffee drinkers |
| N | Other | Other: non-hab cof with water, Other: non-hab cof with dec espresso, Other: non-hab cof with caf espressonon-habitual coffee drinkers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18- 50 years old, healthy
Key exclusion criteria (1 listed)
- Medication, obese(BMI > 30)
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 |
|---|---|---|
| hab cof with waterhabitual coffee drinker provided with water | Other | H |
| hab cof with dec espressohabitual coffee drinkers given decaffeinated espresso | Other | H |
| hab cof with caf espressohabitual coffee drinkers given caffeinated espresso | Other | H |
| non-hab cof with waternon-habitual coffee drinkers given water | Other | N |
| non-hab cof with dec espressonon-habitual coffee drinkers given decaffeinated espresso | Other | N |
| non-hab cof with caf espressonon-habitual coffee drinkers given caffeinated espresso | Other | N |
Primary outcome
Heart rate variability
Time frame: 70 minutes
1 secondary outcome
blood pressure
Time frame: 70 min.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hab cof with water, hab cof with dec espresso and hab cof with caf espresso in people with Influence of Espresso on Heart Rate Variability, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Jul 2010. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
Heart rate variability (time frame: 70 minutes). 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 5 Jul 2010.