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Health Effects of Coffee Consumption (DüsselKaffee)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
test coffee
control coffee
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring overweight, body weight, coffee

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West German Center of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

test coffee

control coffee

Arm Description

test coffee

control coffee

Outcomes

Primary Outcome Measures

body weight
body weight

Secondary Outcome Measures

Full Information

First Posted
December 21, 2012
Last Updated
December 28, 2012
Sponsor
West German Center of Diabetes and Health
Collaborators
Tchibo GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01759329
Brief Title
Health Effects of Coffee Consumption
Acronym
DüsselKaffee
Official Title
Health Effects of Coffee Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
Tchibo GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
overweight, body weight, coffee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test coffee
Arm Type
Experimental
Arm Description
test coffee
Arm Title
control coffee
Arm Type
Active Comparator
Arm Description
control coffee
Intervention Type
Dietary Supplement
Intervention Name(s)
test coffee
Intervention Description
test coffee with higher alkyl pyridine content
Intervention Type
Dietary Supplement
Intervention Name(s)
control coffee
Intervention Description
control coffee with regular alkyl pyridine content
Primary Outcome Measure Information:
Title
body weight
Description
body weight
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stepahn Martin, MD
Organizational Affiliation
WDGZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
West German Center of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25204719
Citation
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.
Results Reference
derived

Learn more about this trial

Health Effects of Coffee Consumption

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