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CompletedNCT01119989AMINOFRUCTUpdated May 4, 2018

Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism

An interventional study of Fructose+maltodextrin placebo and amino-acid + fructose in Metabolic Syndrome, sponsored by University of Lausanne. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-04.

Sponsored by University of Lausanne · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Metabolic Syndrome

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Keywords

  • hepatic fat content
  • hepatic de novo lipogenesis
03

In context

Metabolic Syndrome

1,963 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Lausanne is the lead sponsor of 54 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementFructose+maltodextrin placebo
  • Dietary supplementamino-acid + fructose
06

What researchers measure

Primary outcomes

  1. intrahepatic lipids

    Time frame: after 6 days on each controlled diet

Secondary outcomes

  1. 13C palmitate synthesis

    Time frame: after 6 days on each controlled diet

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, VD CH-1011, Switzerland
08

References and documents

Publications

  • 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. PubMed 23034968 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01119989
Lead sponsor
University of Lausanne
Collaborators
University of Bern
Responsible party
Luc Tappy, MD (Professor of Physiology, University of Lausanne) — Principal investigator
First posted
May 10, 2010
Start date
May 2010
Primary completion
Mar 2011
Completion
Dec 2011
Last update
May 4, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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