- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01759329
Health Effects of Coffee Consumption (DüsselKaffee)
December 28, 2012 updated by: Stephan Martin, West German Center of Diabetes and Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Düsseldorf, Germany, 40591
- West German Center of Diabetes and Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-69 years
- BMI ≥27 kg/m2
- coffee consumption of ≥3 cups per day
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: test coffee
|
test coffee with higher alkyl pyridine content
|
|
Active Comparator: control coffee
|
control coffee with regular alkyl pyridine content
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body weight
Time Frame: 4 months
|
body weight
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stepahn Martin, MD, WDGZ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 21, 2012
First Submitted That Met QC Criteria
December 28, 2012
First Posted (Estimate)
January 3, 2013
Study Record Updates
Last Update Posted (Estimate)
January 3, 2013
Last Update Submitted That Met QC Criteria
December 28, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DüsselKaffee
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
Carmen Lucas AbellánUniversidad Católica San Antonio de MurciaCompletedOverweight/Obesity | Overweight or Obese | Overweight or Obese Adults | Obesity and Overweight | Obese SubjectsSpain
-
Empros Pharma ABNot yet recruitingOverweight or Obese | Obesity and Overweight
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
Children's Hospital Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsActive, not recruitingOverweight and Obesity | Overweight, Childhood | Overweight, InfantFrance
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Medialis Ltd.RecruitingObesity & Overweight | Overweight (BMI > 25)United Kingdom
-
Federal University of Health Science of Porto AlegreCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Active, not recruitingObesity & Overweight | Overweight (BMI > 25)Brazil
Clinical Trials on test coffee
-
University Hospital HeidelbergUnknown
-
University of California, San FranciscoCompletedAtrial Fibrillation | CoffeeAustralia, United States, Canada
-
Mondelēz International, Inc.St. Luke's-Roosevelt Hospital CenterCompleted
-
Eastern Mediterranean UniversityCompletedCardiovascular DiseasesCyprus
-
University of British ColumbiaUnknownInflammatory Response | Cognitive Function | Leukocytosis | TriglyceridesCanada
-
Cedars-Sinai Medical CenterCompletedPostoperative IleusUnited States
-
National University of SingaporeCompleted
-
University of ChileSociété des Produits Nestlé (SPN)Completed
-
Assistance Publique - Hôpitaux de ParisCompletedADCY5-related DyskinesiaFrance
-
Massachusetts Eye and Ear InfirmaryCompleted