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OpenTrials
Completed

NCT Number: NCT01188083

Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Primary Objectives:

1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis. 2. To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal. 3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.

Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.

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Key information

Conditions

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

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Children's Center

Atlanta, Georgia, 30322, United States

About this study

Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects

Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.

Definitions:

  • BMI >95th %tile for age and gender
  • Self-identified as Hispanic/Latino
  • Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease)
  • Sweetened beverage intake of at least 24 ounces/day

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI > 85th %tile
  • Self identified as Hispanic
  • Age 11-18 years
  • Baseline hepatic fat fraction >8%
  • Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).

Exclusion criteria

  • Currently attempting weight gain or weight loss
  • Cirrhosis visible on baseline MRI
  • Renal insufficiency found on screening labs (creatinine > 2)
  • Recent acute illness within past 4 weeks (defined by fever > 100.4ºF)
  • Pregnancy
  • Chronic illness requiring medication including diabetes
  • Fasting glucose >120 on screening labs

Treatment and study plan

Fructose Drink

Dietary Supplement

Fructose Based beverage 8 oz

glucose drink

Dietary Supplement

Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks

Primary outcomes

  1. Hepatic Fat

    Time frame: 2 & 4 Weeks

Secondary outcomes

  1. Plasma Triglycerides

    Time frame: 2 & 4 Weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Acronym: Sweet Bev

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2010
Registry last updated
Nov 21, 2013

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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