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

This study has been completed.
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01119989
First received: May 6, 2010
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Metabolic Syndrome
 Dietary Supplement: control
Dietary Supplement: Fructose+maltodextrin placebo
Dietary Supplement: amino-acid + fructose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of a Supplementation With Amino-acids 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:
  • intrahepatic lipids [ Time Frame: after 6 days on each controlled diet ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 13C palmitate synthesis [ Time Frame: after 6 days on each controlled diet ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: weight maintenance diet Dietary Supplement: control
Placebo Comparator: weight maintenance + fructose Dietary Supplement: Fructose+maltodextrin placebo
Experimental: weight maintenance diet + fructose and amino-acid Dietary Supplement: amino-acid + fructose

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119989

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

No publications provided

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
Study First Received: May 6, 2010
Last Updated: February 23, 2012
Health Authority: Switzerland: etikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013