Pharmacokinetics and Pharmacodynamics of Fructose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00661947
First received: April 16, 2008
Last updated: February 14, 2012
Last verified: October 2011
  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: Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup

Resource links provided by NLM:


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

DNA, whole blood, serum, plasma, and urine


Enrollment: 40
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: August 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

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00661947     History of Changes
Other Study ID Numbers: 682-2007
Study First Received: April 16, 2008
Last Updated: February 14, 2012
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 April 23, 2014