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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827450
First Posted: January 22, 2009
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nestlé Research Center, Vers-chez-les-blanc, Switzerland
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Luc Tappy, MD, University of Lausanne:

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 ]

Enrollment: 13
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
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
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):
Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT00827450     History of Changes
Other Study ID Numbers: COLIBRI
First Submitted: January 20, 2009
First Posted: January 22, 2009
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:
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