HealthyNCT00661947
Pharmacokinetics and Pharmacodynamics of Fructose
An observational study of Healthy, run by University of Florida at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dr Pepper sweetened with sucrose or high fructose corn syrup
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population from Gainesville, FL area.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Department of Pharmacy Practice, Center for Pharmacogenomics
Gainesville, Florida, 32610
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup
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.
- Conditions
- Healthy
- Being tested
- Dr Pepper sweetened with sucrose or high fructose corn syrup
- Keywords
- fructose, sucrose, high fructose corn syrup, serum uric acid, lactate, glucose, triglycerides, Bioavailability of fructose from two formulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr Pepper sweetened with sucrose or high fructose corn syrupOther
Comparison of different formulations of fructose.
| Study group | Role | What they receive |
|---|---|---|
| Public | General public. Those who are not currently taking any medication besides birth control pills. Receives: Other: Dr Pepper sweetened with sucrose or high fructose corn syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fructose
Measured: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
Secondary outcomes (4)
serum uric acid
Measured: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
glucose
Measured: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
lactate
Measured: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
triglycerides
Measured: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie A Johnson, Pharm.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661947
- Sponsor's protocol ID
- 682-2007
- Status last verified
- Oct 2011
- First submitted
- 16 Apr 2008
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Fructose Following Soft Drink Consumption: Sucrose vs High Fructose Corn Syrup
- ClinicalTrials.gov ID
- NCT00661947
- Acronym / sponsor ID
- 682-2007
- Conditions
- Healthy
- Keywords
- fructose, sucrose, high fructose corn syrup, serum uric acid, lactate, glucose, triglycerides, Bioavailability of fructose from two formulations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Public | – | Other: Dr Pepper sweetened with sucrose or high fructose corn syrupGeneral public. Those who are not currently taking any medication besides birth control pills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population from Gainesville, FL area.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dr Pepper sweetened with sucrose or high fructose corn syrupComparison of different formulations of fructose. | Other | Public |
Primary outcome
Fructose
Time frame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
4 secondary outcomes
serum uric acid
Time frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
glucose
Time frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
lactate
Time frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
triglycerides
Time frame: baseline, 15 min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
- Results publication: PubMed 22152650Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Johnson, Pharm.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fructose (time frame: baseline, 15min, 30 min, 60 min, 90 min, 2 hr, 3 hr, 4.5 hr, 6 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.