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Effects of Fructose and Exercise on Hepatic Lipid Metabolism (FRUCTEXER)

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01121003
First received: May 6, 2010
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

8 healthy male volunteers will be studied each on 3 occasions, ie

  • after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity
  • after 4 days on a weight maintenance diet containing 30% fructose + low physical activity
  • after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured

Condition Intervention
Metabolism
 Behavioral: weight maintenance, low sugar diet
Behavioral: weight maintenance, high fructose diet
Behavioral: weight maintenance, high fructose diet+ exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • Hepatic de novo lipogenesis [ Time Frame: after 4 days on controlled diet+exercise ] [ Designated as safety issue: No ]
    Measurement of 13C VLDL palmitate after ingestion of 13C fructose


Secondary Outcome Measures:
  • Plasma VLDL-triglyceride kinetics [ Time Frame: after 4 days on controlled diet+exercise ] [ Designated as safety issue: No ]
    Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol


Estimated Enrollment: 8
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low fructose diet/no exercise Behavioral: weight maintenance, low sugar diet
Experimental: high fructose diet/no exercise Behavioral: weight maintenance, high fructose diet
Experimental: high fructose diet+exercise Behavioral: weight maintenance, high fructose diet+ exercise

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 18 and 30 years
  • males
  • BMI between 19 and 25
  • low to moderate physical activity (< 3 sessions/week)

Exclusion Criteria:

  • smoking
  • consumption of alcohol>50g/week
  • consumption of drugs or illicit substances
  • food allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121003

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Luc Tappy, MD University of Lausanne
  More Information

No publications provided

Responsible Party: Luc Tappy, MD, Professor of Physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT01121003     History of Changes
Other Study ID Numbers: Protocole 220/09
Study First Received: May 6, 2010
Last Updated: October 18, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
Fructose
VLDL-triglycerides
de novo lipogenesis
Human metabolism

ClinicalTrials.gov processed this record on May 23, 2013