Back to resultsHigh Fructose Corn Syrup (Fructose)
Primary Purpose
Nonalcoholic Fatty Liver Disease, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fructose corn syrup diet
Standard diet (low in high fructose corn syrup)
Sponsored by
About this trial
This is an interventional diagnostic trial for Nonalcoholic Fatty Liver Disease focused on measuring Obesity, Nonalcoholic fatty liver disease, High fructose corn syrup
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NAFLD
Non-NAFLD
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Change in intrahepatic triglyceride (IHTG) content
Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).
Hepatic lipid metabolism
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.
Multi-organ insulin sensitivity
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.
Uric acid metabolism
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02018237
First Posted
December 17, 2013
Last Updated
March 22, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02018237
Brief Title
High Fructose Corn Syrup
Acronym
Fructose
Official Title
The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Obesity
Keywords
Obesity, Nonalcoholic fatty liver disease, High fructose corn syrup
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAFLD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-NAFLD
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High fructose corn syrup diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard diet (low in high fructose corn syrup)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in intrahepatic triglyceride (IHTG) content
Description
Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).
Time Frame
4 weeks
Title
Hepatic lipid metabolism
Description
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.
Time Frame
4 weeks
Title
Multi-organ insulin sensitivity
Description
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.
Time Frame
4 weeks
Title
Uric acid metabolism
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelby A Sullivan, MD
Organizational Affiliation
Associate Professor of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Fructose Corn Syrup
We'll reach out to this number within 24 hrs