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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miriam Vos, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01188083
First received: June 9, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Non-alcoholic Fatty-liver Disease
Dietary Supplement: Fructose Drink
Dietary Supplement: Glucose Drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Hepatic Fat [ Time Frame: 2 & 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma Triglycerides [ Time Frame: 2 & 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: June 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fructose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
Dietary Supplement: Fructose Drink
Fructose Based beverage 8 oz
Experimental: Glucose Drink
Subject will drink 3-8oz drinks per day for 4 weeks
Dietary Supplement: Glucose Drink
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks

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
  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188083

Locations
United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Miriam Vos, Md Emory University
  More Information

No publications provided

Responsible Party: Miriam Vos, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01188083     History of Changes
Other Study ID Numbers: IRB00007471, Emory-Vos-SweetBev
Study First Received: June 9, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
NASH
non-alcoholic fatty-liver disease
Hispanic
overweight

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014