Pharmacokinetics and Pharmacodynamics of Fructose

Completed

• Conditions: Healthy
• Interventions: Other: Dr Pepper sweetened with sucrose or high fructose corn syrup

• Registration Number: NCT00661947
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-21
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-10
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Public	Dr Pepper sweetened with sucrose or high fructose corn syrup	General public. Those who are not currently taking any medication besides birth control pills.

Primary Outcome Measures

Name	Time	Method
Fructose	baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

Secondary Outcome Measures

Name	Time	Method
serum uric acid	baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
glucose	baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
lactate	baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
triglycerides	baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr

Trial Locations

Locations (1)

University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics; 🇺🇸 Gainesville, Florida, United States