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CompletedNCT01188083Sweet BevUpdated Nov 21, 2013

Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

An interventional study of Fructose Drink and Glucose Drink in Non-alcoholic Fatty-liver Disease, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-11-21.

Sponsored by Emory University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
11 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed 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
02

Conditions studied

  • Non-alcoholic Fatty-liver Disease

Keywords

  • NASH
  • non-alcoholic fatty-liver disease
  • Hispanic
  • overweight
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 53 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.

Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.

Browse Emory University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Fructose Drink

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

    Dietary Supplement: Fructose Drink

  • Experimental
    Glucose Drink

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

    Dietary Supplement: Glucose Drink

Interventions

  • Dietary supplementFructose Drink

    Fructose Based beverage 8 oz

  • Dietary supplementGlucose Drink

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

06

What researchers measure

Primary outcomes

  1. Hepatic Fat

    Time frame: 2 & 4 Weeks

Secondary outcomes

  1. Plasma Triglycerides

    Time frame: 2 & 4 Weeks

07

Study locations

1 site
  • Emory Children's Center
    Atlanta, Georgia 30322, United States
08

References and documents

Publications

  • Holzberg JR, Jin R, Le NA, Ziegler TR, Brunt EM, McClain CJ, Konomi JV, Arteel GE, Vos MB. Plasminogen Activator Inhibitor-1 Predicts Quantity of Hepatic Steatosis Independent of Insulin Resistance and Body Weight. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):819-23. doi: 10.1097/MPG.0000000000001096. PubMed 26704864 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01188083
Lead sponsor
Emory University
Responsible party
Miriam Vos, MD (Principal Investigator, Emory University) — Principal investigator
First posted
Aug 25, 2010
Start date
Jun 2009
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 21, 2013

Study contacts

Miriam Vos, Md
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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