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

Hepatic Steatosis Clinical Trial

— COLIBRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827450
• Other study ID #: COLIBRI
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: February 23, 2012
• Start date: February 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2012
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis

Intervention

Dietary Supplement:
• Ctl
Control, isocaloric diet; no coffee
• High fructose diet; no coffee
Hypercaloric, high fructose diet; no coffee
• fully torrefied, caffeine-free coffee
Hypercaloric, high fructose diet + coffee
• partially torrefied, caffeine-free coffee
Hypercaloric, high fructose diet + coffee
• Partially torrefied, caffeinated coffee
Hypercaloric, high fructose diet + coffee

Locations

Country	Name	City	State
Switzerland	Centre d'investigations cliniques "cardiomet"/ CHUV	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Nestlé Research Center, Vers-chez-les-blanc, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-hepatocellular lipid (IHCL) concentration		will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement	No
Secondary	fasting plasma triglycerides		will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement	No
Secondary	fasting net lipid oxidation		will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement	No
Secondary	fasting net carbohydrate oxidation		will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement	No
Secondary	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	No
Secondary	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	No
Secondary	whole body glycerol turnover (2H5 glycerol)		will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement	No