Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis (Sweet Bev)

Emory University

Status: Completed

Conditions: Non-alcoholic Fatty-liver Disease

Treatments: Dietary Supplement: Glucose Drink; Dietary Supplement: Fructose Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01188083

IRB00007471

Emory-Vos-SweetBev (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 2 patient groups

Fructose Drink

Experimental group

Description:

Subject will drink 3-8oz drinks per day for 4 weeks

Treatment:

Dietary Supplement: Fructose Drink

Glucose Drink

Experimental group

Description:

Subject will drink 3-8oz drinks per day for 4 weeks

Treatment:

Dietary Supplement: Glucose Drink