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

Primary Purpose

Hepatic Steatosis

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Ctl

High fructose diet; no coffee

fully torrefied, caffeine-free coffee

partially torrefied, caffeine-free coffee

Partially torrefied, caffeinated coffee

About this trial

This is an interventional prevention trial for Hepatic Steatosis focused on measuring hepatic steatosis, coffee, fructose, lipids

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Centre d'investigations cliniques "cardiomet"/ CHUV

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Ctl

Arm Description

control isocaloric diet; no coffee

Hypercaloric. high fructose diet; no coffee

Hypercaloric, high fructose diet; caffeine-free, torrefied coffee

Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee

Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee

Outcomes

Primary Outcome Measures

intra-hepatocellular lipid (IHCL) concentration

Secondary Outcome Measures

fasting plasma triglycerides

fasting net lipid oxidation

fasting net carbohydrate oxidation

whole body ketone bodies turnover and oxidation (13C 3-hydroxybutyrate)

whole body glucose turnover (6,6 2H2 glucose)

whole body glycerol turnover (2H5 glycerol)

Full Information

NCT ID

NCT00827450

First Posted

January 20, 2009

Last Updated

February 23, 2012

Sponsor

University of Lausanne

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00827450

Brief Title

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

Acronym

COLIBRI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Lausanne

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Steatosis

Keywords

hepatic steatosis, coffee, fructose, lipids

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ctl

Arm Type

Placebo Comparator

Arm Description

control isocaloric diet; no coffee

Arm Title

Arm Type

Placebo Comparator

Arm Description

Hypercaloric. high fructose diet; no coffee

Arm Title

Arm Type

Experimental

Arm Description

Hypercaloric, high fructose diet; caffeine-free, torrefied coffee

Arm Title

Arm Type

Experimental

Arm Description

Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee

Arm Title

Arm Type

Experimental

Arm Description

Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee

Intervention Type

Dietary Supplement

Intervention Name(s)

Ctl

Intervention Description

Control, isocaloric diet; no coffee

Intervention Type

Dietary Supplement

Intervention Name(s)

High fructose diet; no coffee

Intervention Description

Hypercaloric, high fructose diet; no coffee

Intervention Type

Dietary Supplement

Intervention Name(s)

fully torrefied, caffeine-free coffee

Intervention Description

Hypercaloric, high fructose diet + coffee

Intervention Type

Dietary Supplement

Intervention Name(s)

partially torrefied, caffeine-free coffee

Intervention Description

Hypercaloric, high fructose diet + coffee

Intervention Type

Dietary Supplement

Intervention Name(s)

Partially torrefied, caffeinated coffee

Intervention Description

Hypercaloric, high fructose diet + coffee

Primary Outcome Measure Information:

Title

intra-hepatocellular lipid (IHCL) concentration

Time Frame