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CompletedNCT00661947Updated Feb 16, 2012

Pharmacokinetics and Pharmacodynamics of Fructose

An observational study in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-16.

Sponsored by University of Florida · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • fructose
  • sucrose
  • high fructose corn syrup
  • serum uric acid
  • lactate
  • glucose
  • triglycerides
  • Bioavailability of fructose from two formulations
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

General population from Gainesville, FL area.

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

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
05

Study design

Time perspective
Prospective
Enrollment
40 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherDr Pepper sweetened with sucrose or high fructose corn syrup

    Comparison of different formulations of fructose.

06

What researchers measure

Primary outcomes

  1. Fructose

    Time frame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

Secondary outcomes

  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

07

Study locations

1 site
  • University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics
    Gainesville, Florida 32610, United States
08

References and documents

Publications

  • Le MT, Frye RF, Rivard CJ, Cheng J, McFann KK, Segal MS, Johnson RJ, Johnson JA. Effects of high-fructose corn syrup and sucrose on the pharmacokinetics of fructose and acute metabolic and hemodynamic responses in healthy subjects. Metabolism. 2012 May;61(5):641-51. doi: 10.1016/j.metabol.2011.09.013. Epub 2011 Dec 5. PubMed 22152650 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00661947
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Apr 21, 2008
Start date
Mar 2008
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Feb 16, 2012

Study contacts

Julie A Johnson, Pharm.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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