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Study Title and Description

Fructose and oxidized low-density lipoprotein in pediatric nonalcoholic fatty liver disease: a pilot study



Key Questions Addressed
2 What are the relationships between fructose consumption and indices of liver health?
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3 Risk of Bias - RCTs and non-RCT
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Primary Publication Information
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TitleData
Title Fructose and oxidized low-density lipoprotein in pediatric nonalcoholic fatty liver disease: a pilot study
Author Vos et al.
Country
Year 2009
Numbers 524 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Fructose and NAFLD
Arms
Number Title Description Comments
1 low fructose Elimination of sugar containing beverages, fruit juice, and food items in which high fructose corn syrup was one of the top five ingredients
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2 Low fat Based on American Heart Association recommendations
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Randomized Control Trial (parallel)
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source American College of Gastroenterology, National Institute of Child Health and Human Development
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Inclusion Criteria -Children with NAFLD (7 had confirmatory liver biopsy for NASH and remainder used serology and ultrasonography)
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Exclusion Criteria nd
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Location USA
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question low fructose Low fat Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 10
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N Analyzed 10
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Mean (SD) Age, yrs 13.3(0.65) in low fructose group, 12.5 (1.0) in low-fat group
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Age range (IQR) nd
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Male % nd
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Anthropometry data BMI z score BMI z score: 2(0.2) in low fructose group, 2.3(0.2) in low fat group
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Alcohol Intake nd
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Co-morbidity (other diseases/conditions) nd
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Other important baseline characteristics or baseline confounders All were children with NAFLD
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Background Diet Baseline diet in low fructose group Baseline diet in low fat group
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multiplepass, 24-hour dietary recall at 0, 1, 5, and 6 months Energy (kcal/d) =2412 (229) Carbohydrate (% of total kcals)= 52 (3) Fructose (g)= 43 (16) Fat (% of total kcals)= 35 (3) Protein (% of total kcals)= 14 (1)
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Food and Nutrient Database at the University of Minnesota
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n
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Energy (kcal/d) = 1729 (166) (significantly different between groups, but energy intake controlling for weight not significantly different) Carbohydrate (% of total kcals) = 59 (3) Fructose (g) = 53 (15) Fat (% of total kcals) = 31 (2) Protein (% of total kcals)= 12.0 (1)
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Race/Ethnicity nd
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Results & Comparisons


Results Data
N Analyzed Mean Difference (Net) Standard Error 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure low fructose Low fat Comparison Measure low fructose vs. Low fat


0 N/A

N Analyzed 6 4 10
Unit IU/L IU/L nd
Baseline Value 71.2 65.3 nd
Baseline Standard Error 12.2 25.6 nd
Final Value 51.0 51.8 nd
Final Standard Error 13.0 20.9 ns
N Analyzed Mean Difference (Net) Standard Error 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure low fructose Low fat Comparison Measure low fructose vs. Low fat


0 N/A

N Analyzed 6 4 10
Unit IU/L IU/L nd
Baseline Value 125.5 103.3 nd
Baseline Standard Error 22.0 55.6 nd
Final Value 83.8 92.5 nd
Final Standard Error 25.4 49.6 ns

Adverse Events
Arm or Total Title Description Comments
low fructose Not Reported
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Low fat
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
N Analyzed Mean Difference (Net) Standard Error 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure low fructose Low fat Comparison Measure low fructose vs. Low fat


0 N/A

N Analyzed 6 4 10
Unit IU/L IU/L nd
Baseline Value 71.2 65.3 nd
Baseline Standard Error 12.2 25.6 nd
Final Value 51.0 51.8 nd
Final Standard Error 13.0 20.9 ns
N Analyzed Mean Difference (Net) Standard Error 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure low fructose Low fat Comparison Measure low fructose vs. Low fat


0 N/A

N Analyzed 6 4 10
Unit IU/L IU/L nd
Baseline Value 125.5 103.3 nd
Baseline Standard Error 22.0 55.6 nd
Final Value 83.8 92.5 nd
Final Standard Error 25.4 49.6 ns


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] No Data
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2) Was the treatment allocation concealed? No Data
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3) Was the patient blinded to the intervention? [Yes, No, Unsure] No
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4) Was the care provider blinded to the intervention? [Yes, No, Unsure] No Data
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5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] No Data
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6) Was the dropout rate described and acceptable? [Yes, No, Unsure] 0
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7) Analyzed in the group to which they were allocated? [Yes, No, Unsure] Yes
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8) Are reports of the study free of suggestion of selective outcome reporting? [Yes, No, Unsure] Yes
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9) Were the groups similar at baseline regarding the most important risk factors of NAFLD (e.g. comorbidity, background diet)? [Yes, No, Unsure] No
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10) Were co-interventions avoided or similar? [Yes, No, Unsure] No Data
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11) Was the compliance acceptable (greater than 80%) in all groups? [Yes, No, Unsure] No Data
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12) Was the timing of the outcome assessment similar in all groups? [Yes, No, Unsure] Yes
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13) Was the total fructose intake (including intervention dose and background fructose intake from diet) measured? [Yes, No, Unsure] Yes
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Quality Rating
Guideline Used Overall Rating
High