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

Sponsor

University of Lausanne (Other)

Overall Status

Completed

CT.gov ID

NCT00827450

Collaborator

Nestlé Research Center, Vers-chez-les-blanc, Switzerland (Other)

Enrollment

Location

Arms

24.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

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 :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Mar 1, 2011

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 [will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement]

Secondary Outcome Measures

fasting plasma triglycerides [will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement]
fasting net lipid oxidation [will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement]
fasting net carbohydrate oxidation [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) [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) [will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement]
whole body glycerol turnover (2H5 glycerol) [will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luc Tappy, MD, professor of physiology, University of Lausanne

ClinicalTrials.gov Identifier:

NCT00827450

Other Study ID Numbers:

COLIBRI

First Posted:

Jan 22, 2009

Last Update Posted:

Feb 24, 2012

Last Verified:

Feb 1, 2012

Keywords provided by Luc Tappy, MD, professor of physiology, University of Lausanne

Additional relevant MeSH terms:

Fatty Liver

Caffeine

Study Results

No Results Posted as of Feb 24, 2012