Pharmacokinetics and Pharmacodynamics of Fructose - Full Text View

Sponsor:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00661947

Purpose

The purpose of this study is to determine whether sucrose vs high fructose corn syrup from a soft drink results in differences in various metabolic byproducts such as fructose, glucose, serum uric acid, triglyceride and lactate.

Condition	Intervention
Healthy	Other: Dr Pepper sweetened with sucrose or high fructose corn syrup

Study Type:	Observational
Study Design:	Prospective
Official Title:	Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup

Resource links provided by NLM:

Drug Information available for: Fructose Sucrose

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Fructose [ Time Frame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

serum uric acid [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ] [ Designated as safety issue: No ]
glucose [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ] [ Designated as safety issue: No ]
lactate [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ] [ Designated as safety issue: No ]
triglycerides [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

DNA, whole blood, serum, plasma, and urine

Estimated Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Public General public. Those who are not currently taking any medication besides birth control pills.	Other: Dr Pepper sweetened with sucrose or high fructose corn syrup Comparison of different formulations of fructose.

Detailed Description:

Fructose consumption has risen sharply during the past several decades. Since its introduction to the United States in 1967, high fructose corn syrup (HFCS) has overtaken sucrose as the main sweetener in manufactured foods and beverages, and thus, is responsible for the approximately 30% increase in fructose in our diet. Numerous studies have shown that excessive fructose consumption can cause a variety of harmful metabolic effects, suggesting that fructose may partially be responsible for the current epidemic in obesity, hypertension, metabolic syndrome, and diabetes.

This preliminary study will investigate the pharmacokinetics and pharmacodynamics of fructose in a broad population. Specifically, the goal of our research are to compare the impact of the two main sources of dietary fructose, sucrose versus HFCS, on fructose bioavailability and acute metabolic changes by measuring response phenotypes, such as serum uric acid, lactate, and triglyceride levels.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

General population from Gainesville, FL area.

Criteria

Inclusion Criteria:

adult subjects aged 18 years or older
either gender
any ethnicity
willing to abstain from drinking any alcohol 3 days prior to a study visit

Exclusion Criteria:

history of liver or kidney disease
history of diabetes mellitus or fasting blood glucose ≥ 126 mg/dl or random blood glucose ≥ 200 mg/dl
currently taking any medication (except oral contraceptives)
consume more than 1 alcoholic drink per day
pregnant or breast-feeding
blood donor in the previous 8 weeks
history of gout

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661947

Locations

United States, Florida
University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Julie A Johnson, Pharm.D.

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics ( Julie A. Johnson, Pharm.D. )
Study ID Numbers:	682-2007
Study First Received:	April 16, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00661947 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

fructose
sucrose
high fructose corn syrup
serum uric acid

lactate
glucose
triglycerides
Bioavailability of fructose from two formulations

ClinicalTrials.gov processed this record on February 08, 2010