Clinical trial NCT00661947: Pharmacokinetics and Pharmacodynamics of Fructose
Official title: Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: fructose
sucrose
high fructose corn syrup
serum uric acid
lactate
glucose
triglycerides
Bioavailability of fructose from two formulations
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population from Gainesville, FL area.

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.

Eligibility 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

Primary outcomes:
measure: Fructose
timeFrame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
Secondary outcomes:
measure: serum uric acid
timeFrame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
measure: glucose
timeFrame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
measure: lactate
timeFrame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
measure: triglycerides
timeFrame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics
state: Florida
Study officials:
affiliation: University of Florida
name: Julie A Johnson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.