Health Effects of Coffee Consumption

NCT ID: NCT01759329

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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test coffee

test coffee

Group Type EXPERIMENTAL

test coffee

Intervention Type DIETARY_SUPPLEMENT

test coffee with higher alkyl pyridine content

control coffee

control coffee

Group Type ACTIVE_COMPARATOR

control coffee

Intervention Type DIETARY_SUPPLEMENT

control coffee with regular alkyl pyridine content

Interventions

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test coffee

test coffee with higher alkyl pyridine content

Intervention Type DIETARY_SUPPLEMENT

control coffee

control coffee with regular alkyl pyridine content

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tchibo GmbH

UNKNOWN

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stepahn Martin, MD

Role: PRINCIPAL_INVESTIGATOR

WDGZ

Locations

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West German Center of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25204719 (View on PubMed)

Other Identifiers

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DüsselKaffee

Identifier Type: -

Identifier Source: org_study_id

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