NCT00620360

Brief Summary

It has been widely documented that fructose overfeeding increases plasma triglycerides and hepatic de novo lipogenesis, and impairs insulin sensitivity in healthy male volunteers. The effect of gender on the metabolic responses to fructose remains an important open question, however. The objective of this study is to compare the effect of an acute oral fructose load on carbohydrate and lipid metabolism in healthy young males and females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

February 8, 2008

Last Update Submit

February 23, 2012

Conditions

Lipid Metabolism

Keywords

dietary fructoseplasma lipidshealthy humansgender differenceshepatic de novo lipogenesis

Outcome Measures

Primary Outcomes (1)

  • Hepatic de novo lipogenesis

    acute effect of dietary fructose (within 6 hours)

Secondary Outcomes (1)

  • Whole body lipid oxidation, glucose turnover, glycerol turnover, plasma substrates, hormone and energy expenditure (free fatty acid, glucose, lactate, beta-hydroxybutyrate, glycerol, VLDL- Triglycerides and insulin) expression of key adipose genes

    acute effect of fructose (within 6 hours)

Study Arms (1)

fructose

EXPERIMENTAL

acute fructose administration

Dietary Supplement: fructose

Interventions

FructoseDIETARY_SUPPLEMENT

acute administration of 4 times 0.3g fructose/kg lean body mass

fructose

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females
  • Age 18-35
  • Healthy
  • Body mass indexes (BMI) between 19 and 25 kg/m2
  • Informed consent obtained

You may not qualify if:

  • Smokers
  • Alcohol intake \> 30g/day
  • Drug abuse
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Interventions

Fructose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Luc Tappy, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of physiology

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

CH(1)