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Pharmacokinetics and Pharmacodynamics of Fructose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661947
First Posted: April 21, 2008
Last Update Posted: February 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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 ]

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 ]
  • glucose [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]
  • lactate [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]
  • triglycerides [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: February 16, 2012
Last Verified: October 2011

Keywords provided by University of Florida:
fructose
sucrose
high fructose corn syrup
serum uric acid
lactate
glucose
triglycerides
Bioavailability of fructose from two formulations