OverweightDüsselKaffeeNCT01759329
Health Effects of Coffee Consumption
A study testing test coffee in people with Overweight, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- test coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2011
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-69 years
- BMI ≥27 kg/m2
- coffee consumption of ≥3 cups per day
Who cannot join
- new diagnosed type 2 diabetes during the last 6 months
- severe diseases with hospital stay during the last 3 months
- change of body weight of more than 2 kg per week during the last 4 weeks
- smoking cessation during the last 3 months or planned during the study
- acute infects
- chronical diseases with except of type 2 diabetes mellitus
Show all 10Show fewer
- regular pharmacological therapy with except of oral antidiabetic medication or contraception
- lack of contraception in women
- breastfeeding
- physical activity of more than 1 hour per day
Trial locations and contacts
1 site in 1 country.
About this study
Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.
Read the detailed description
Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.
- Conditions
- Overweight
- Being tested
- test coffee, control coffee
- Keywords
- overweight, body weight, coffee
- Medical subject headings
- Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test coffeeDietary supplement
test coffee with higher alkyl pyridine content
control coffeeDietary supplement
control coffee with regular alkyl pyridine content
| Study group | Role | What they receive |
|---|---|---|
| test coffee | Experimental | test coffee Receives: Dietary Supplement: test coffee |
| control coffee | Active comparator | control coffee Receives: Dietary Supplement: control coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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 OverweightStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Tchibo GmbH
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
- Investigators
- Stepahn Martin, MD, Principal investigator, WDGZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759329
- Sponsor's protocol ID
- DüsselKaffee
- Acronym
- DüsselKaffee
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kempf K, Kolb H, Gartner B, Bytof G, Stiebitz H, Lantz I, Lang R, Hofmann T, Martin S. Cardiometabolic effects of two coffee blends differing in content for major constituents in overweight adults: a randomized controlled trial. Eur J Nutr. 2015 Aug;54(5):845-54. doi: 10.1007/s00394-014-0763-3. Epub 2014 Sep 10.
PubMed 25204719
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Coffee Consumption
- ClinicalTrials.gov ID
- NCT01759329
- Acronym / sponsor ID
- DüsselKaffee / DüsselKaffee
- Conditions
- Overweight
- Keywords
- overweight, body weight, coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- Tchibo GmbH
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jan 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.
Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.
Detailed description
Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test coffee | Experimental | Dietary Supplement: test coffeetest coffee |
| control coffee | Active comparator | Dietary Supplement: control coffeecontrol coffee |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-69 years
- BMI ≥27 kg/m2
- coffee consumption of ≥3 cups per day
Key exclusion criteria (10 listed)
- new diagnosed type 2 diabetes during the last 6 months
- severe diseases with hospital stay during the last 3 months
- change of body weight of more than 2 kg per week during the last 4 weeks
- smoking cessation during the last 3 months or planned during the study
- acute infects
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 |
|---|---|---|
| test coffeetest coffee with higher alkyl pyridine content | Dietary supplement | test coffee |
| control coffeecontrol coffee with regular alkyl pyridine content | Dietary supplement | control coffee |
Primary outcome
body weight
Time frame: 4 months
body weight
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 3 Jan 2013.
- Derived from this study: PubMed 25204719Kempf K, Kolb H, Gartner B, Bytof G, Stiebitz H, Lantz I, Lang R, Hofmann T, Martin S. Cardiometabolic effects of two coffee blends differing in content for major constituents in overweight adults: a randomized controlled trial. Eur J Nutr. 2015 Aug;54(5):845-54. doi: 10.1007/s00394-014-0763-3. Epub 2014 Sep 10.
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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.
Stepahn Martin, MD principal investigator
WDGZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test coffee in people with Overweight, run by West German Center of Diabetes and Health 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 3 inclusion and 10 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 3 Jan 2013. 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 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?
body weight (time frame: 4 months). 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 NCT01759329, 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 3 Jan 2013.