Overview

This trial is active, not recruiting.

Conditions nonalcoholic fatty liver disease, obesity
Treatments high fructose corn syrup diet, standard diet (low in high fructose corn syrup)
Sponsor Washington University School of Medicine
Start date March 2012
End date February 2017
Trial size 30 participants
Trial identifier NCT02018237, 2011-12111

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
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.
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.
(Active Comparator)
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.
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.

Primary Outcomes

Measure
Change in intrahepatic triglyceride (IHTG) content
time frame: 4 weeks
Hepatic lipid metabolism
time frame: 4 weeks
Multi-organ insulin sensitivity
time frame: 4 weeks
Uric acid metabolism
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - IHTG >8% 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

Additional Information

Official title The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
Principal investigator Shelby A Sullivan, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.