NCT01121003

Brief Summary

8 healthy male volunteers will be studied each on 3 occasions, ie

  • after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity
  • after 4 days on a weight maintenance diet containing 30% fructose + low physical activity
  • after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

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
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

1.4 years

First QC Date

May 6, 2010

Last Update Submit

October 18, 2011

Conditions

Metabolism

Keywords

FructoseVLDL-triglyceridesde novo lipogenesisHuman metabolism

Outcome Measures

Primary Outcomes (1)

  • Hepatic de novo lipogenesis

    Measurement of 13C VLDL palmitate after ingestion of 13C fructose

    after 4 days on controlled diet+exercise

Secondary Outcomes (1)

  • Plasma VLDL-triglyceride kinetics

    after 4 days on controlled diet+exercise

Study Arms (3)

Low fructose diet/no exercise

OTHER
Behavioral: weight maintenance, low sugar diet

high fructose diet/no exercise

EXPERIMENTAL
Behavioral: weight maintenance, high fructose diet

high fructose diet+exercise

EXPERIMENTAL
Behavioral: weight maintenance, high fructose diet+ exercise

Interventions

weight maintenance, low sugar dietBEHAVIORAL
Low fructose diet/no exercise
weight maintenance, high fructose dietBEHAVIORAL
high fructose diet/no exercise
weight maintenance, high fructose diet+ exerciseBEHAVIORAL
high fructose diet+exercise

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 30 years
  • males
  • BMI between 19 and 25
  • low to moderate physical activity (\< 3 sessions/week)

You may not qualify if:

  • smoking
  • consumption of alcohol\>50g/week
  • consumption of drugs or illicit substances
  • food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Study Officials

  • Luc Tappy, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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

May 6, 2010

First Posted

May 11, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

CH(1)