High Fructose Corn Syrup

Study Overview
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Brief Summary
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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.

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

Conditions
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Nonalcoholic Fatty Liver Disease, Obesity

Intervention / Treatment
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* Behavioral: High fructose corn syrup diet
* Behavioral: Standard diet (low in high fructose corn syrup)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAFLD<br>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. | Behavioral: High fructose corn syrup diet<br>* 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.<br>Behavioral: Standard diet (low in high fructose corn syrup)<br>* 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.<br>|
| Active Comparator: Non-NAFLD<br>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. | Behavioral: High fructose corn syrup diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Nonalcoholic fatty liver disease, High fructose corn syrup