Acute Effect of Fructose on Lipid Metabolism and Gender Differences - Full Text View

Sponsored by:	University of Lausanne
Information provided by:	University of Lausanne
ClinicalTrials.gov Identifier:	NCT00620360

Purpose

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.

Condition	Intervention
Lipid Metabolism	Dietary Supplement: fructose Dietary Supplement: Fructose

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Fructose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Acute Effect of Fructose on Lipid Metabolism and Gender Differences

Further study details as provided by University of Lausanne:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	16
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
fructose: Experimental acute fructose administration	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

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

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620360

Contacts

Contact: Luc Tappy, MD

0041 21 692 55 41

luc.tappy@unil.ch

Locations

Switzerland, Vaud
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Vaud, Switzerland, 1005
Principal Investigator: Luc Tappy, MD

Sponsors and Collaborators

University of Lausanne

Investigators

Principal Investigator:

Luc Tappy, MD

University of Lausanne

More Information

No publications provided

Responsible Party:	Department of Physiology, Lausanne University ( Prof Luc Tappy )
Study ID Numbers:	279/07/CE/FBM
Study First Received:	February 8, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00620360 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne:

dietary fructose
plasma lipids
healthy humans
gender differences
hepatic de novo lipogenesis

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 06, 2009