Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet (COLIBRI)
This study has been completed.
Sponsor:
University of Lausanne
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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
| 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 May 21, 2013