Health Effects of Coffee Consumption (DüsselKaffee)

This study has been completed.
Sponsor:
Collaborator:
Tchibo GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01759329
First received: December 21, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Overweight
Dietary Supplement: test coffee
Dietary Supplement: control coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Health Effects of Coffee Consumption

Further study details as provided by West German Center of Diabetes and Health:

Primary Outcome Measures:
  • body weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    body weight


Enrollment: 118
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test coffee
test coffee
Dietary Supplement: test coffee
test coffee with higher alkyl pyridine content
Active Comparator: control coffee
control coffee
Dietary Supplement: control coffee
control coffee with regular alkyl pyridine content

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759329

Locations
Germany
West German Center of Diabetes and Health
Düsseldorf, Germany, 40591
Sponsors and Collaborators
West German Center of Diabetes and Health
Tchibo GmbH
Investigators
Principal Investigator: Stepahn Martin, MD WDGZ
  More Information

No publications provided

Responsible Party: Stephan Martin, principal investigator, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT01759329     History of Changes
Other Study ID Numbers: DüsselKaffee
Study First Received: December 21, 2012
Last Updated: December 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by West German Center of Diabetes and Health:
overweight
body weight
coffee

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014