NCT00827450

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

January 20, 2009

Last Update Submit

February 23, 2012

Conditions

Hepatic Steatosis

Keywords

hepatic steatosiscoffeefructoselipids

Outcome Measures

Primary Outcomes (1)

  • intra-hepatocellular lipid (IHCL) concentration

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (5)

Ctl

PLACEBO COMPARATOR

control isocaloric diet; no coffee

Dietary Supplement: Ctl

HF

PLACEBO COMPARATOR

Hypercaloric. high fructose diet; no coffee

Dietary Supplement: High fructose diet; no coffee

C1

EXPERIMENTAL

Hypercaloric, high fructose diet; caffeine-free, torrefied coffee

Dietary Supplement: fully torrefied, caffeine-free coffee

C2

EXPERIMENTAL

Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee

Dietary Supplement: partially torrefied, caffeine-free coffee

C3

EXPERIMENTAL

Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee

Dietary Supplement: Partially torrefied, caffeinated coffee

Interventions

CtlDIETARY_SUPPLEMENT

Control, isocaloric diet; no coffee

Ctl
High fructose diet; no coffeeDIETARY_SUPPLEMENT

Hypercaloric, high fructose diet; no coffee

HF
fully torrefied, caffeine-free coffeeDIETARY_SUPPLEMENT

Hypercaloric, high fructose diet + coffee

C1
partially torrefied, caffeine-free coffeeDIETARY_SUPPLEMENT

Hypercaloric, high fructose diet + coffee

C2
Partially torrefied, caffeinated coffeeDIETARY_SUPPLEMENT

Hypercaloric, high fructose diet + coffee

C3

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigations cliniques "cardiomet"/ CHUV

Lausanne, CH-1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24257718DERIVED

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Luc Tappy, MD

    Department of Physiology, University of Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of physiology

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

CH(1)