Hepatic SteatosisCOLIBRINCT00827450
Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet
A study testing Ctl, High fructose diet; no coffee and fully torrefied, caffeine-free coffee in people with Hepatic Steatosis, run by University of Lausanne at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Steatosis
- What is being tested?
- Ctl, High fructose diet; no coffee and fully torrefied, caffeine-free coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre d'investigations cliniques "cardiomet"/ CHUV
Lausanne, CH-1011
About this study
Official title: Effects of Coffees With Various Compositions of Antioxidants on Hepatic Steatosis Induced by a High Fructose, Hypercaloric Diet
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
Read the 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.
- Conditions
- Hepatic Steatosis
- Being tested
- Ctl, High fructose diet; no coffee, fully torrefied, caffeine-free coffee, partially torrefied, caffeine-free coffee, Partially torrefied, caffeinated coffee
- Keywords
- hepatic steatosis, coffee, fructose, lipids
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CtlDietary supplement
Control, isocaloric diet; no coffee
High fructose diet; no coffeeDietary supplement
Hypercaloric, high fructose diet; no coffee
fully torrefied, caffeine-free coffeeDietary supplement
Hypercaloric, high fructose diet + coffee
partially torrefied, caffeine-free coffeeDietary supplement
Hypercaloric, high fructose diet + coffee
Partially torrefied, caffeinated coffeeDietary supplement
Hypercaloric, high fructose diet + coffee
| Study group | Role | What they receive |
|---|---|---|
| Ctl | Placebo comparator | control isocaloric diet; no coffee Receives: Dietary Supplement: Ctl |
| HF | Placebo comparator | Hypercaloric. high fructose diet; no coffee Receives: Dietary Supplement: High fructose diet; no coffee |
| C1 | Experimental | Hypercaloric, high fructose diet; caffeine-free, torrefied coffee Receives: Dietary Supplement: fully torrefied, caffeine-free coffee |
| C2 | Experimental | Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee Receives: Dietary Supplement: partially torrefied, caffeine-free coffee |
| C3 | Experimental | Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee Receives: Dietary Supplement: Partially torrefied, caffeinated coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-hepatocellular lipid (IHCL) concentration
Measured: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
Secondary outcomes (6)
fasting plasma triglycerides
Measured: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
fasting net lipid oxidation
Measured: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
fasting net carbohydrate oxidation
Measured: 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)
Measured: 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)
Measured: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
whole body glycerol turnover (2H5 glycerol)
Measured: will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Research Center, Vers-chez-les-blanc, Switzerland
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, Department of Physiology, University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827450
- Sponsor's protocol ID
- COLIBRI
- Acronym
- COLIBRI
- Status last verified
- Feb 2012
- First submitted
- 20 Jan 2009
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lecoultre V, Carrel G, Egli L, Binnert C, Boss A, MacMillan EL, Kreis R, Boesch C, Darimont C, Tappy L. Coffee consumption attenuates short-term fructose-induced liver insulin resistance in healthy men. Am J Clin Nutr. 2014 Feb;99(2):268-75. doi: 10.3945/ajcn.113.069526. Epub 2013 Nov 20.
PubMed 24257718
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coffees With Various Compositions of Antioxidants on Hepatic Steatosis Induced by a High Fructose, Hypercaloric Diet
- ClinicalTrials.gov ID
- NCT00827450
- Acronym / sponsor ID
- COLIBRI / COLIBRI
- Conditions
- Hepatic Steatosis
- Keywords
- hepatic steatosis, coffee, fructose, lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Nestlé Research Center, Vers-chez-les-blanc, Switzerland
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ctl | Placebo comparator | Dietary Supplement: Ctlcontrol isocaloric diet; no coffee |
| HF | Placebo comparator | Dietary Supplement: High fructose diet; no coffeeHypercaloric. high fructose diet; no coffee |
| C1 | Experimental | Dietary Supplement: fully torrefied, caffeine-free coffeeHypercaloric, high fructose diet; caffeine-free, torrefied coffee |
| C2 | Experimental | Dietary Supplement: partially torrefied, caffeine-free coffeeHypercaloric, high fructose diet; caffeine-free, partially torrefied coffee |
| C3 | Experimental | Dietary Supplement: Partially torrefied, caffeinated coffeeHypercaloric, high fructose diet; caffeinated, partially torrefied coffee |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CtlControl, isocaloric diet; no coffee | Dietary supplement | Ctl |
| High fructose diet; no coffeeHypercaloric, high fructose diet; no coffee | Dietary supplement | HF |
| fully torrefied, caffeine-free coffeeHypercaloric, high fructose diet + coffee | Dietary supplement | C1 |
| partially torrefied, caffeine-free coffeeHypercaloric, high fructose diet + coffee | Dietary supplement | C2 |
| Partially torrefied, caffeinated coffeeHypercaloric, high fructose diet + coffee | Dietary supplement | C3 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- Derived from this study: PubMed 24257718Lecoultre V, Carrel G, Egli L, Binnert C, Boss A, MacMillan EL, Kreis R, Boesch C, Darimont C, Tappy L. Coffee consumption attenuates short-term fructose-induced liver insulin resistance in healthy men. Am J Clin Nutr. 2014 Feb;99(2):268-75. doi: 10.3945/ajcn.113.069526. Epub 2013 Nov 20.
Related trials for Hepatic Steatosis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Tappy, MD principal investigator
Department of Physiology, University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ctl, High fructose diet; no coffee and fully torrefied, caffeine-free coffee in people with Hepatic Steatosis, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.