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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014