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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00620360
Other study ID # 279/07/CE/FBM
Secondary ID
Status Completed
Phase N/A
First received February 8, 2008
Last updated February 23, 2012
Start date January 2008
Est. completion date December 2008

Study information

Verified date February 2012
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatic de novo lipogenesis acute effect of dietary fructose (within 6 hours) No
Secondary 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) No
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