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

This study is currently recruiting participants.
Verified June 2011 by Emory University
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT01188083
First received: June 9, 2010
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  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, VLDL, 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
NAFLD
 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:

Drug Information available for: Dextrose
U.S. FDA Resources

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 ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 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 NAFLD 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188083

Contacts
Contact: Nicholas Raviele, BS 4047273189 nicholas.raviele@emory.edu

Locations
United States, Georgia
Emory Children's Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nicholas Raviele, BS     404-727-3189     nicholas.raviele@emory.edu    
Principal Investigator: Miriam Vos, MD            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Miriam Vos, Md Emory University
  More Information

No publications provided

Responsible Party: Miriam Vos, MD, Emory University School of Medicine
ClinicalTrials.gov Identifier: NCT01188083     History of Changes
Other Study ID Numbers: Emory-Vos-SweetBev
Study First Received: June 9, 2010
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
NASH
NAFLD
Hispanic
overweight

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

ClinicalTrials.gov processed this record on May 16, 2013