Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Non-alcoholic Fatty-liver Disease Clinical Trial

— Sweet Bev  

Official title:

Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188083
• Other study ID #: IRB00007471
• Secondary ID: Emory-Vos-SweetB
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: November 20, 2013
• Start date: June 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty-liver Disease

Intervention

Dietary Supplement:
• Fructose Drink
Fructose Based beverage 8 oz
• Glucose Drink
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks

Locations

Country	Name	City	State
United States	Emory Children's Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic Fat		2 & 4 Weeks	Yes
Secondary	Plasma Triglycerides		2 & 4 Weeks	No