NCT01119989

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

May 6, 2010

Last Update Submit

May 1, 2018

Conditions

Keywords

hepatic fat contenthepatic de novo lipogenesis

Outcome Measures

Primary Outcomes (1)

  • intrahepatic lipids

    after 6 days on each controlled diet

Secondary Outcomes (1)

  • 13C palmitate synthesis

    after 6 days on each controlled diet

Study Arms (3)

weight maintenance diet

NO INTERVENTION

weight maintenance + fructose

PLACEBO COMPARATOR
Dietary Supplement: Fructose+maltodextrin placebo

weight maintenance diet + fructose and amino-acid

EXPERIMENTAL
Dietary Supplement: amino-acid + fructose

Interventions

weight maintenance + fructose
amino-acid + fructoseDIETARY_SUPPLEMENT
weight maintenance diet + fructose and amino-acid

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Amino AcidsFructose

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physiology

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 10, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

December 1, 2011

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations