High Fructose Corn Syrup

NCT02018237 | Completed DMC

• 1 other identifier: 2011-12111
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Nonalcoholic fatty liver disease; High fructose corn syrup

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

NAFLD

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.

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

Non-NAFLD

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.

Behavioral: High fructose corn syrup diet

Interventions

High fructose corn syrup diet 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.

NAFLD; Non-NAFLD

Standard diet (low in high fructose corn syrup) 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.

NAFLD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

High Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Sugars; Dietary Carbohydrates; Carbohydrates; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shelby A Sullivan, MD

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Samuel Klein, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

US (1)