search
Back to results

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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Fructose+maltodextrin placebo
amino-acid + fructose
Sponsored by
University of Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring hepatic fat content, hepatic de novo lipogenesis

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

weight maintenance diet

weight maintenance + fructose

weight maintenance diet + fructose and amino-acid

Arm Description

Outcomes

Primary Outcome Measures

intrahepatic lipids

Secondary Outcome Measures

13C palmitate synthesis

Full Information

First Posted
May 6, 2010
Last Updated
May 1, 2018
Sponsor
University of Lausanne
Collaborators
University of Bern
search

1. Study Identification

Unique Protocol Identification Number
NCT01119989
Brief Title
Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism
Acronym
AMINOFRUCT
Official Title
Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne
Collaborators
University of Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
hepatic fat content, hepatic de novo lipogenesis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weight maintenance diet
Arm Type
No Intervention
Arm Title
weight maintenance + fructose
Arm Type
Placebo Comparator
Arm Title
weight maintenance diet + fructose and amino-acid
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose+maltodextrin placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
amino-acid + fructose
Primary Outcome Measure Information:
Title
intrahepatic lipids
Time Frame
after 6 days on each controlled diet
Secondary Outcome Measure Information:
Title
13C palmitate synthesis
Time Frame
after 6 days on each controlled diet

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
VD
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23034968
Citation
Theytaz F, Noguchi Y, Egli L, Campos V, Buehler T, Hodson L, Patterson BW, Nishikata N, Kreis R, Mittendorfer B, Fielding B, Boesch C, Tappy L. Effects of supplementation with essential amino acids on intrahepatic lipid concentrations during fructose overfeeding in humans. Am J Clin Nutr. 2012 Nov;96(5):1008-16. doi: 10.3945/ajcn.112.035139. Epub 2012 Oct 3.
Results Reference
derived

Learn more about this trial

Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism

We'll reach out to this number within 24 hrs