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Completed

NCT Number: NCT02018237

High Fructose Corn Syrup

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in intrahepatic triglyceride (IHTG) content

    Time frame: 4 weeks

    Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).

  2. Hepatic lipid metabolism

    Time frame: 4 weeks

    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.

  3. Multi-organ insulin sensitivity

    Time frame: 4 weeks

    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. Uric acid metabolism

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: Fructose

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2013
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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