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

This study has been completed.
Sponsor:
Collaborator:
Nestlé Research Center, Vers-chez-les-blanc, Switzerland
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT00827450
First received: January 20, 2009
Last updated: February 23, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • fasting net lipid oxidation [ Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement ] [ Designated as safety issue: No ]
  • fasting net carbohydrate oxidation [ Time Frame: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Lausanne

Additional 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
Study First Received: January 20, 2009
Last Updated: February 23, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 20, 2014