Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Completed · Not applicable

Conditions studied: Non-alcoholic Fatty-liver Disease

In brief

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.

Key facts

Study ID

NCT01188083

Run by

Emory University

People needed

53

Starts

2009-06-01

Expected to finish

2012-11-01

Last updated by the study team

2013-11-21

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Emory Children's Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.