Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Sweet Bev
2 other identifiers
interventional
53
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 21, 2013
November 1, 2013
3.4 years
June 9, 2010
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatic Fat
2 & 4 Weeks
Secondary Outcomes (1)
Plasma Triglycerides
2 & 4 Weeks
Study Arms (2)
Fructose Drink
EXPERIMENTALSubject will drink 3-8oz drinks per day for 4 weeks
Glucose Drink
EXPERIMENTALSubject will drink 3-8oz drinks per day for 4 weeks
Interventions
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory Children's Center
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 26704864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miriam Vos, Md
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 9, 2010
First Posted
August 25, 2010
Study Start
June 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 21, 2013
Record last verified: 2013-11