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

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ClinicalTrials.gov Identifier: NCT00827450

Recruitment Status : Completed

First Posted : January 22, 2009

Last Update Posted : February 24, 2012

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Luc Tappy, MD, University of Lausanne

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

Condition or disease	Intervention/treatment	Phase
Hepatic Steatosis	Dietary Supplement: Ctl Dietary Supplement: High fructose diet; no coffee Dietary Supplement: fully torrefied, caffeine-free coffee Dietary Supplement: partially torrefied, caffeine-free coffee Dietary Supplement: Partially torrefied, caffeinated coffee	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Effects of Coffees With Various Compositions of Antioxidants on Hepatic Steatosis Induced by a High Fructose, Hypercaloric Diet
Study Start Date :	February 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

fasting plasma triglycerides [ Time Frame: 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 ]
fasting net carbohydrate oxidation [ Time Frame: 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 ]
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 ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 30 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827450

Locations

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

Sponsors and Collaborators

University of Lausanne

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

Investigators

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Principal Investigator:	Luc Tappy, MD	Department of Physiology, University of Lausanne, Switzerland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lecoultre V, Carrel G, Egli L, Binnert C, Boss A, MacMillan EL, Kreis R, Boesch C, Darimont C, Tappy L. Coffee consumption attenuates short-term fructose-induced liver insulin resistance in healthy men. Am J Clin Nutr. 2014 Feb;99(2):268-75. doi: 10.3945/ajcn.113.069526. Epub 2013 Nov 20.

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Responsible Party:	Luc Tappy, MD, professor of physiology, University of Lausanne
ClinicalTrials.gov Identifier:	NCT00827450
Other Study ID Numbers:	COLIBRI
First Posted:	January 22, 2009 Key Record Dates
Last Update Posted:	February 24, 2012
Last Verified:	February 2012

Keywords provided by Luc Tappy, MD, University of Lausanne:


hepatic steatosis coffee fructose lipids

Additional relevant MeSH terms:

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Fatty Liver Liver Diseases Digestive System Diseases Caffeine Central Nervous System Stimulants Physiological Effects of Drugs Phosphodiesterase Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents

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