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Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism (AMINOFRUCT)

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ClinicalTrials.gov Identifier: NCT01119989
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

Brief Summary:

10 healthy male volunteers will be studied after

  • a 6 day weight maintenance, balanced diet
  • a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day
  • a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day At the end of each 6 days period, the following measurements will be obtained
  • intrahepatic lipids (1H-MRS)
  • metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)

This is a randomized, double blinded study


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Fructose+maltodextrin placebo Dietary Supplement: amino-acid + fructose Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism
Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: weight maintenance diet
Placebo Comparator: weight maintenance + fructose Dietary Supplement: Fructose+maltodextrin placebo
Experimental: weight maintenance diet + fructose and amino-acid Dietary Supplement: amino-acid + fructose



Primary Outcome Measures :
  1. intrahepatic lipids [ Time Frame: after 6 days on each controlled diet ]

Secondary Outcome Measures :
  1. 13C palmitate synthesis [ Time Frame: after 6 days on each controlled diet ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-30 years
  • sex: males
  • BMI between 19 and 25 kg/m2
  • less than 3 30min- exercise session/week

Exclusion Criteria:

  • smokers
  • alcohol consumption more than 50g/week
  • consumption of drugs
  • history of diabetes in first degree relatives
  • presence of ferro-magnetic prosthesis, cardiac pacemakers, or any contra-indication to NMR

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119989


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
University of Bern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luc Tappy, MD, Professor of Physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT01119989     History of Changes
Other Study ID Numbers: protocole 51/10
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Luc Tappy, MD, University of Lausanne:
hepatic fat content
hepatic de novo lipogenesis

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases