Effects of Fructose and Exercise on Hepatic Lipid Metabolism | NCT01121003

Studies
Effects of Fructose and Exercise on Hepatic Lipid Metabolism

NCT01121003

Sponsor

University of Lausanne

Status

Completed

Last Update Posted

Oct 19, 2011Estimated

Enrollment

8Estimated

Phase

Not Applicable

Conditions

Metabolism

Interventions

weight maintenance, low sugar diet
weight maintenance, high fructose diet
weight maintenance, high fructose diet+ exercise

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2011

Last Update Posted Date

Oct 19, 2011Estimated

Name	Class
Centre Hospitalier Universitaire Vaudois	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
weight maintenance, low sugar diet	Behavioral		Low fructose diet/no exercise
weight maintenance, high fructose diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatic de novo lipogenesis	Measurement of 13C VLDL palmitate after ingestion of 13C fructose	after 4 days on controlled diet+exercise

Secondary Outcomes

Measure	Description	Time Frame
Plasma VLDL-triglyceride kinetics	Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol	after 4 days on controlled diet+exercise

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc Tappy, MD	University of Lausanne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Vaudois		Lausanne	Canton of Vaud	CH-1011	Switzerland