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

May 1, 2018 updated by: Luc Tappy, MD, University of Lausanne

Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intrahepatic lipids
Time Frame: after 6 days on each controlled diet
after 6 days on each controlled diet

Secondary Outcome Measures

Outcome Measure
Time Frame
13C palmitate synthesis
Time Frame: after 6 days on each controlled diet
after 6 days on each controlled diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Collaborators

University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (ESTIMATE)

May 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocole 51/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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