High Fructose Corn Syrup

Obesity Clinical Trial

— Fructose  

Official title:

The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018237
• Other study ID #: 2011-12111
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: March 22, 2017
• Start date: March 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Obesity

Intervention

Behavioral:
• High fructose corn syrup diet
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.
• Standard diet (low in high fructose corn syrup)
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks