High Fructose Corn Syrup

NCT ID: NCT02018237

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Nonalcoholic Fatty Liver Disease; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High fructose corn syrup diet

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

High fructose corn syrup diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelby A Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Medicine

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

2011-12111

Identifier Type: -

Identifier Source: org_study_id