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
  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:


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
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: 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 September 16, 2014