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Study Title and Description

Nonalcoholic fatty liver disease in humans is associated with increased plasma endotoxin and plasminogen activator inhibitor 1 concentrations and with fructose intake.



Key Questions Addressed
1 What is the effect of fructose consumption on the risk of NAFLD? a) Is there a dose-response relationship between fructose intake and NAFLD? b) Does the relationship between fructose intake and NAFLD exhibit a threshold effect within or beyond the range of typical fructose intakes? c) What factors modify the effect of fructose consumption on NAFLD?
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5 Risk of Bias - Cross-Sectional Studies
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Primary Publication Information
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TitleData
Title Nonalcoholic fatty liver disease in humans is associated with increased plasma endotoxin and plasminogen activator inhibitor 1 concentrations and with fructose intake.
Author Thuy S., Ladurner R., Volynets V., Wagner S., Strahl S., Königsrainer A., Maier KP., Bischoff SC., Bergheim I.
Country Department of Nutritional Medicine (180a), University of Hohenheim, 70599 Stuttgart, Germany.
Year 2008
Numbers Pubmed ID: 18641190
555 (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 NAFLD (Fructose)
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2 Healthy/Isocaloric (Fructose)
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3 NAFLD (Sucrose)
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4 Healthy/Isocaloric (Sucrose)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Case-control
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source nd
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Inclusion Criteria -Undergoing liver biopsy or partial liver resection (e.g. because of liver metastasis) -No history of taking lipid-lowering drugs or drugs affecting lipid metabolism -No known medical conditions affecting lipid and glucose metabolism -No medical records of alcohol abuse and alcohol intake <15g/d ethanol -No drug-induced hepatotoxicity -No infection with hepatitis B or C virus -No clinical indication of impaired nutritional status
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Exclusion Criteria nd
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Location Germany
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question NAFLD (Fructose) Healthy/Isocaloric (Fructose) NAFLD (Sucrose) Healthy/Isocaloric (Sucrose) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 12 6 18
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N Analyzed 12 6 18
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Mean (SD) Age, yrs 47 +/- 7 55 +/- 4
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Age range (IQR) nd nd nd
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Male % 75 34
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Anthropometry data BMI 27.8 +/- 0.7 BMI 22.5 +/- 1.2
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Alcohol Intake >15 g/d ethanol
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Co-morbidity (other diseases/conditions) nd
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Other important baseline characteristics or baseline confounders half of cases participated in leisure physical activity All controls participated in leisure physical activity
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Background Diet Dietary fructose intake derived from free fructose and sucrose Dietary fructose intake derived from free fructose and sucrose
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"Assessed by nutritionist" "Assessed by nutritionist"
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No description. Software used: EBISpro (Germany) No description. Software used: EBISpro (Germany)
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nd nd
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Total Energy kJ/d= 9387 +/- 461 Fructose intake (g/d) = Cases: 51.5 +/- 5.2 Total Energy kJ/d= 9106 +/- 670 Fructose intake (g/d) = Controls: 41.0 +/- 3.2
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Race/Ethnicity nd
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Results & Comparisons


Results Data
P-Value
Outcome: NAFLD      Population: All Participants Between-Arm Comparisons
Time Point Measure NAFLD (Fructose) Healthy/Isocaloric (Fructose) NAFLD (Sucrose) Healthy/Isocaloric (Sucrose) Comparison Measure NAFLD (Fructose) vs. Healthy/Isocaloric (Fructose) NAFLD (Sucrose) vs. Healthy/Isocaloric (Sucrose)


0 N/A

N Analyzed 12 6 12 6 <0.05 ns
Crude or Adjusted Analysis crude crude crude crude
Mean sugar level/dose 51.5 41.0 57.3 48.3
Sugar level/dose Standard Error 5.2 3.2 6.3 7.2
Time between baseline exposure and outcome assessment nd nd nd nd

Adverse Events
Arm or Total Title Description Comments
NAFLD (Fructose) Not Reported
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Healthy/Isocaloric (Fructose)
NAFLD (Sucrose)
Healthy/Isocaloric (Sucrose)
Total

Extraction Form: Case Control & Cross Sectional Quality


Results & Comparisons


Results Data
P-Value
Outcome: NAFLD      Population: All Participants Between-Arm Comparisons
Time Point Measure NAFLD (Fructose) Healthy/Isocaloric (Fructose) NAFLD (Sucrose) Healthy/Isocaloric (Sucrose) Comparison Measure NAFLD (Fructose) vs. Healthy/Isocaloric (Fructose) NAFLD (Sucrose) vs. Healthy/Isocaloric (Sucrose)


0 N/A

N Analyzed 12 6 12 6 <0.05 ns
Crude or Adjusted Analysis crude crude crude crude
Mean sugar level/dose 51.5 41.0 57.3 48.3
Sugar level/dose Standard Error 5.2 3.2 6.3 7.2
Time between baseline exposure and outcome assessment nd nd nd nd


Quality Dimensions
Dimension Value Notes Comments
1) Is the case definition adequate? c
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2) Representativeness of the cases b
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3) Selection of controls b
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4) Definition of controls b
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5) Comparability of cases and controls on the basis of the design or analysis: age and sex a
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6) Comparability of cases and controls on the basis of the design or analysis: anthropometrics a
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7) Comparability of cases and controls on the basis of the design or analysis: nutrient and energy intake b
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8) Ascertainment of exposure e
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9) Same method of ascertainment for cases and controls a
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10) Description of a validated method to quantify the amount, per type, of nutrients of interest d only software described
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11) Non-response rate c
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Quality Rating
Guideline Used Overall Rating
High