NCT01759329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

December 21, 2012

Last Update Submit

December 28, 2012

Conditions

Keywords

overweightbody weightcoffee

Outcome Measures

Primary Outcomes (1)

  • body weight

    body weight

    4 months

Study Arms (2)

test coffee

EXPERIMENTAL

test coffee

Dietary Supplement: test coffee

control coffee

ACTIVE COMPARATOR

control coffee

Dietary Supplement: control coffee

Interventions

test coffeeDIETARY_SUPPLEMENT

test coffee with higher alkyl pyridine content

test coffee
control coffeeDIETARY_SUPPLEMENT

control coffee with regular alkyl pyridine content

control coffee

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-69 years
  • BMI ≥27 kg/m2
  • coffee consumption of ≥3 cups per day

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West German Center of Diabetes and Health

Düsseldorf, 40591, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stepahn Martin, MD

    WDGZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 3, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations