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Study Title and Description

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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
Author Volynets et al.
Country
Year 2012
Numbers

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 Grant from the Center of Nutritional Medicine Hohenheim/Tubingen
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Inclusion Criteria Subjects were recruited at the hospital. -Cases: NAFLD ranging from simple steatosis to seatoheapatitis -Controls: no NAFLD
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Exclusion Criteria history of taking lipid-lowering drugs or drugs affecting lipid metabolism -a known medical condition affecting lipid and glucose metabolism (diabetes) -medical records of alcohol abuse and alcohol intake >15 g ethanol/day -drug-induced hepatotoxicity -infection with hepatitis B or C virus -Autoimmune liver disorder, heochromatosis, etc -clinical indication of an impaired nutritional status, and abnormal dietary habits (vegetarian) -current or previous use of antibiotics within last 3 months
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Location Germany
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Confounders no
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yes
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age, sex
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no
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no
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no
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no
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yes
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physical activity
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no
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yes
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Counfounders Yes
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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 20 10 30
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N Analyzed 20 10 30
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Mean (SD) Age, yrs 41.9 +/- 2.3 39.6 +/- 3.9
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Age range (IQR) nd
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Male % 45 30
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Anthropometry data BMI 33.1 +/- 1.9 BMI 23.1 +/- 1.0
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Alcohol Intake <15 g ethanol/day
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Co-morbidity (other diseases/conditions) Pre-diabetic conditions for some patients discovered from blood glucose tests
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Other important baseline characteristics or baseline confounders Physical exercise, age, sex
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Background Diet nd Total Energy: 2100 kcal/d Sucrose: 50.5 g/d Fructose: 39.8 g/d
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Total Energy: 2701 kcal/d Sucrose: 72.2 g/d Fructose: 58.2 g/d nd
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Food Frequency Questionnaire (EBISpro©, germany) Food Frequency Questionnaire (EBISpro©, germany)
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nd nd
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no no
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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 20 10 20 10 <0.05 <0.05
Time between baseline exposure and outcome assessment nd nd nd nd
crude or adjusted analysis Crude Crude Crude Crude
mean sugar level/dose 58.2 39.8 72.2 50.5
sugar level Standard Error 4.4 3.8 7.1 3.7

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 20 10 20 10 <0.05 <0.05
Time between baseline exposure and outcome assessment nd nd nd nd
crude or adjusted analysis Crude Crude Crude Crude
mean sugar level/dose 58.2 39.8 72.2 50.5
sugar level Standard Error 4.4 3.8 7.1 3.7


Quality Dimensions
Dimension Value Notes Comments
1) Is the case definition adequate? a
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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 a
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5) Comparability of cases and controls on the basis of the design or analysis: age and sex a based on Table 1
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6) Comparability of cases and controls on the basis of the design or analysis: anthropometrics b
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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 instrument described
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11) Non-response rate c
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Quality Rating
Guideline Used Overall Rating
High