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Completed

NCT Number: NCT00661947

Pharmacokinetics and Pharmacodynamics of Fructose

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dr Pepper sweetened with sucrose or high fructose corn syrup

Other

Comparison of different formulations of fructose.

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2008
Registry last updated
Feb 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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