Acute Effect of Fructose on Lipid Metabolism and Gender Differences

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Luc Tappy, MD, University of Lausanne

ClinicalTrials.gov Identifier:

NCT00620360

First received: February 8, 2008

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2008

Last Updated Date

February 23, 2012

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hepatic de novo lipogenesis [ Time Frame: acute effect of dietary fructose (within 6 hours) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00620360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: acute effect of fructose (within 6 hours) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acute Effect of Fructose on Lipid Metabolism and Gender Differences

Official Title ^ICMJE

Acute Effect of Fructose on Lipid Metabolism and Gender Differences

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.

Detailed Description

The study is aimed at comparing the effects of oral fructose on several specific metabolic pathways in males and females.Participants will receive an isoenergetic diet containing 55% carbohydrate, 15% protein and 35% lipids for three days prior to testing. After this period of controlled diet, they will be studied for 2 hours in the post-absorptive state (Time 0-120 min) and over a 6 hours period (Time 120-480 min) during which they will receive 4 loads of 0,30 g/kg fat free mass U-13C labelled fructose, at times 120, 180, 240, 300. Throughout the study, deuterated glucose and glycerol will be infused to monitor whole body glucose production and glycerol turnover.

The following parameters will be monitored in basal conditions and after the ingestion of the load of fructose:

Glycerol turnover(glycerol 2H5)
de novo lipogenesis (incorporation of 13C into palmitate of VLDLs)
whole body energy expenditure and net substrate oxydation (indirect calorimetry)
net fructose oxidation (breath 13CO2)
glucose turnover: (6,6 2H2 Glucose)
plasma glucose, free fatty acids, ketone bodies, lactate, insulin, triacylglycerol, total cholesterol, VLDL, LDL, and HDL subfractions

An adipose tissue (periumbilical subcutaneous) biopsy will be obtaine by needle aspiration under local anesthesia in fasting conditions (time 0 min) and after fructose (time 480 min) to assess the effects of fructose on adipose gene expression profile. Key genes involved in the regulation of carbohydrate (GLUT 4, hexokinase, PDH-kinase), lipid (FAT-CD36, FABP, acetylCoA carboxylase, malonyl-CoA decarboxylase, PPARg) and energy metabolism (PGC-1a, UCP2)will be monitored

Results obtained in males and females will be compared with two-way analysis of variance

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Lipid Metabolism

Intervention ^ICMJE

Dietary Supplement: fructose
acute administration of 4 times 0.3g fructose/kg lean body mass
Dietary Supplement: Fructose
acute administration of 4 times 0.3 g/kg fat-free mass oral fructose

Study Arm (s)

Experimental: fructose

acute fructose administration

Interventions:

Dietary Supplement: fructose
Dietary Supplement: Fructose

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00620360

Other Study ID Numbers ^ICMJE

279/07/CE/FBM

Has Data Monitoring Committee

Responsible Party

Luc Tappy, MD, University of Lausanne

Study Sponsor ^ICMJE

University of Lausanne

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luc Tappy, MD

University of Lausanne

Information Provided By

University of Lausanne

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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