Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet (COLIBRI)

February 23, 2012 updated by: Luc Tappy, MD, University of Lausanne

Effects of Coffees With Various Compositions of Antioxidants on Hepatic Steatosis Induced by a High Fructose, Hypercaloric Diet

This study will assess

  • whether coffee consumption protects against fructose-induced hepatic steatosis in healthy humans
  • whether the protective effect of coffee is dependent on it's antioxidant composition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidemiological studies suggest that coffee consumption improves glucose homeostasis in insulin resistant subjects. An increase in intrahepatic lipids (hepatic steatosis) is highly prevalent in patients with the metabolic syndrome and may be used as a marker of altered hepatic lipid metabolism. Such an increased hepatic lipids content can be experimentally produced in healthy humans by a 6-day high fructose diet.

The purpose of this study is to evaluate whether coffee prevents hepatic lipid deposition in healthy male subjects fed a fructose-rich hypercaloric diet. Both caffeine and antioxidants (yet unspecified) may be involved.. To sort out the role of caffeine and antioxidants, we will test 3 different soluble coffee, ie fully torrefied decaffeinated coffee , partially torrefied decaffeinated coffee, and partially torrefied caffeinated coffee.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre d'investigations cliniques "cardiomet"/ CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI between 19 and 15 kg/m2
  • less than 30 min physical activity /day
  • habitual coffee consumption less than three cupy /day
  • consumption of caffeine-containing sodas less than 2 servings/day
  • non-smoker

Exclusion Criteria:

  • consumption of alcohol more than 40g/day
  • presence of metallic foreign bodies
  • history of eye surgery
  • family history of diabetes mellitus
  • history of food intolerance
  • vegetarians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Ctl
control isocaloric diet; no coffee
Dietary supplement: Ctl
Control, isocaloric diet; no coffee
PLACEBO_COMPARATOR: HF
Hypercaloric. high fructose diet; no coffee
Dietary supplement: High fructose diet; no coffee
Hypercaloric, high fructose diet; no coffee
EXPERIMENTAL: C1
Hypercaloric, high fructose diet; caffeine-free, torrefied coffee
Dietary supplement: fully torrefied, caffeine-free coffee
Hypercaloric, high fructose diet + coffee
EXPERIMENTAL: C2
Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee
Dietary supplement: partially torrefied, caffeine-free coffee
Hypercaloric, high fructose diet + coffee
EXPERIMENTAL: C3
Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee
Dietary supplement: Partially torrefied, caffeinated coffee
Hypercaloric, high fructose diet + coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intra-hepatocellular lipid (IHCL) concentration
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting plasma triglycerides
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
fasting net lipid oxidation
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
fasting net carbohydrate oxidation
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
whole body ketone bodies turnover and oxidation (13C 3-hydroxybutyrate)
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
whole body glucose turnover (6,6 2H2 glucose)
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
whole body glycerol turnover (2H5 glycerol)
Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Collaborators

Nestlé Research Center, Vers-chez-les-blanc, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Colibri

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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