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Pharmacokinetics and Pharmacodynamics of Fructose

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ClinicalTrials.gov Identifier: NCT00661947
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment
Healthy Other: Dr Pepper sweetened with sucrose or high fructose corn syrup

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup
Study Start Date : March 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Fructose [ Time Frame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]

Secondary Outcome Measures :
  1. serum uric acid [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]
  2. glucose [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]
  3. lactate [ Time Frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr ]
  4. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Julie A Johnson, Pharm.D. University of Florida
Publications of Results:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00661947    
Other Study ID Numbers: 682-2007
First Posted: April 21, 2008    Key Record Dates
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