- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018237
High Fructose Corn Syrup (Fructose)
March 22, 2017 updated by: Washington University School of Medicine
The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease.
Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IHTG >6.5% or <5%
- BMI 30.0-45.0 kg/m²
- Sedentary
- Consume <10% calories from high fructose corn syrup
- Weight stable for previous 3 months
Exclusion Criteria:
- IHTG 5.1-7.9%
- Children
- Adults over 65 years
- Pregnant
- Lactating
- Exercise >1.5 hours/week
- Hepatitis B or C
- Diabetes
- History of liver disease
- History of alcohol abuse
- Severe hypertriglyceridemia (>300 mg/dl)
- Smokers
- Anemia (Hemoglobin <10mg/dl)
- Not weight stable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: NAFLD
Subjects with nonalcoholic fatty liver disease (NAFLD) will complete baseline testing and then be assigned to either the high fructose corn syrup diet or the standard diet (low in high fructose corn syrup) for 4 weeks.
Post intervention testing will be completed after the subjects have completed the 4 week diet intervention.
|
Subjects will consume a high fructose corn syrup diet for 4 weeks.
The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
Subjects will consume a standard diet (low in high fructose corn syrup) for 4 weeks.
The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
|
ACTIVE_COMPARATOR: Non-NAFLD
Subjects without nonalcoholic fatty liver disease (Non-NAFLD) will complete baseline testing and then be fed a high fructose corn syrup diet for 4 weeks.
Post intervention testing will be completed after the subjects have completed the 4 week diet intervention.
|
Subjects will consume a high fructose corn syrup diet for 4 weeks.
The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intrahepatic triglyceride (IHTG) content
Time Frame: 4 weeks
|
Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).
|
4 weeks
|
Hepatic lipid metabolism
Time Frame: 4 weeks
|
Determine the effect of 4-week isocaloric diet high in HFCS on hepatic lipid metabolism [de novo lipogenesis, very low density lipoprotein-triglyceride (VLDL-TG) and very low density lipoprotein-Apolipoprotein B100 (VLDL-ApoB) secretion rates] by using stable isotope tracer methods.
|
4 weeks
|
Multi-organ insulin sensitivity
Time Frame: 4 weeks
|
Determine the effect of 4-week isocaloric diet high in HFCS on multi-organ insulin sensitivity by using a one stage hyperinsulinemic euglycemic clamp procedure in conjunction with muscle and adipose tissue biopsies.
|
4 weeks
|
Uric acid metabolism
Time Frame: 4 weeks
|
Determine the effect of 4-week isocaloric diet high in HFCS on uric acid metabolism by measuring post-prandial serum uric acid concentrations and using stable isotope tracer method.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shelby A Sullivan, MD, Associate Professor of Medicine
- Principal Investigator: Samuel Klein, MD, Professor of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
December 17, 2013
First Submitted That Met QC Criteria
December 17, 2013
First Posted (ESTIMATE)
December 23, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-12111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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