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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01188083
First Posted: August 25, 2010
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miriam Vos, MD, Emory University
  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: Quadruple (Participant, Care Provider, 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 Miriam Vos, MD, Emory University:

Primary Outcome Measures:
  • Hepatic Fat [ Time Frame: 2 & 4 Weeks ]

Secondary Outcome Measures:
  • Plasma Triglycerides [ Time Frame: 2 & 4 Weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Miriam Vos, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01188083     History of Changes
Other Study ID Numbers: IRB00007471
Emory-Vos-SweetBev ( Other Identifier: Other )
First Submitted: June 9, 2010
First Posted: August 25, 2010
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Miriam Vos, MD, Emory University:
NASH
non-alcoholic fatty-liver disease
Hispanic
overweight

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases