Metabolic Impact of Fructose Restriction in Obese Children (SUCRE)
The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the metabolic diseases that go along with obesity, termed "metabolic syndrome". Obese children with metabolic disease will be studied before and after 10 days of a fructose restricted diet. The question is whether their co-morbidities will improve, even if weight remains constant.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metabolic Impact of Fructose Restriction in Obese Children|
- intrahepatic fat content [ Time Frame: 10 days ] [ Designated as safety issue: No ]We anticipate fructose restriction to reduce intrahepatic fat, exclusive of calories
- insulin resistance [ Time Frame: 10 days ] [ Designated as safety issue: No ]We anticipate fructose restriction will improve insulin sensitvity exclusive of calories
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: fructose restriction
Isocaloric fructose restricted diet for 10 days
Other: fructose restriction diet
fruits and vegetables only
Recent studies suggest that specific types of macronutrients in the diet may have selective effects on nutrient absorption, insulin sensitivity, and lipid metabolism. Elucidation of the metabolic impact of specific dietary components may well result in improved efficacy of lifestyle approaches to reduce obesity and metabolic diseases. Despite similar fructose consumption, the phenotype of co-morbidities is different between African Americans and Latinos. Latino and Caucasian children manifest worsened dyslipidemia and non-alcoholic fatty liver disease (NAFLD), while African American children manifest worsened insulin resistance and hypertension. We have also documented in adults that a reduction in de novo lipogenesis (DNL; production of new lipids) in the liver and liver fat content, and improvement in hepatic insulin sensitivity were achieved by substitution of complex carbohydrate for fructose; but these changes appeared less dramatic in African American compared to Latino or Caucasian subjects. These divergent findings suggest ethnic and race-specific differences of fructose metabolism and disposition.
To determine whether fructose is a contributor to metabolic co-morbidity in children, we will conduct a convenience cohort within-subject intervention with repeated measures, stratified by racial/ethnic group (Latinos vs. African Americans vs. Caucasians). The intervention will consist of restricting fructose ingestion only to naturally-occurring fructose in fruits and vegetables (approximately 15 gm/day for 10 days), by substituting complex carbohydrate for excess dietary fructose, while maintaining neutral energy balance. We anticipate fructose restriction to differentially improve co-morbidities in different racial/ethnic groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200043
|Contact: Kelly C Jordan, B.A.||firstname.lastname@example.org|
|United States, California|
|San Franciso, California, United States, 94143|
|Contact: Robert Lustig, M.D. 415-502-8672 RLustig@peds.ucsf.edu|
|Principal Investigator: Robert Lustig, MD|