Health Effects of Coffee Consumption

Overweight Clinical Trial

— DüsselKaffee  

Official title:

Health Effects of Coffee Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759329
• Other study ID #: DüsselKaffee
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: December 28, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• test coffee
test coffee with higher alkyl pyridine content
• control coffee
control coffee with regular alkyl pyridine content

Locations

Country	Name	City	State
Germany	West German Center of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Tchibo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight	4 months	No