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Study Title and Description

Cholesterol synthesis is associated with hepatic lipid content and dependent on fructose/glucose intake in healthy humans



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 Cholesterol synthesis is associated with hepatic lipid content and dependent on fructose/glucose intake in healthy humans
Author Silbernagel 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 Fructose
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2 Glucose
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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 2008
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Trial or Cohort Name The Tuebingen Fructose or Glucose Study (TUFROG)
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Funding Source German Research Foundation, Zentrum Emahrungsmedizin Tubingen-Hohenheim
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Inclusion Criteria -Age 20-50 y -BMI 20-35 -physically healthy -not more than 1 h sports/wk
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Exclusion Criteria -pregnancy -any relevant illness (i.e. diabetes, dyslipidaemia, endocrine disease, coronary artery disease, malignancy, gastrointestinal disease and psychological disease) -fructose intolerance -medication -metal implants (e.g. pacemaker, metal heart valve) -regular alcohol consumption >= 10 g/d -claustrophobia.
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Location Germany
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Fructose Glucose Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 25
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N Analyzed 10 10 20
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Mean (SD) Age, yrs 30.5 (8.9)
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Age range (IQR) ND - Inclusion criteria = 20-50 yrs
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Male % 60%
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Anthropometry data BMI 25.9 (2.2)
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Alcohol Intake Alcohol Consumption <10 g/d
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Co-morbidity (other diseases/conditions) No
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Other important baseline characteristics or baseline confounders Alcohol Consumption <10 g/d, BMI similar between groups
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Background Diet ND
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ND
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ND
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ND
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ND
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Race/Ethnicity nd
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Results & Comparisons


Results Data
P-Value Reported Net Difference Calculated Net Difference Reported Net 95% Confidence Interval Lower limit Reported Net 95% Confidence Interval Upper limit Calculated Net 95% Confidence Interval Lower Limit Calculated Net 95% Confidence Interval Upper Limit
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Comparison Measure Fructose vs. Glucose


Enter a numeric value or title (required) years

N Analyzed 10 10 0.975
Unit % Signal % Signal 0.01
Baseline 1.32 1.59 0.07
Delta +0.45 +0.52 -0.98
Baseline Standard Error 0.29 0.26 0.96
Delta Standard Error 0.30 0.34 -0.959
0.819

Adverse Events
Arm or Total Title Description Comments
Fructose Not Reported
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Glucose
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
P-Value Reported Net Difference Calculated Net Difference Reported Net 95% Confidence Interval Lower limit Reported Net 95% Confidence Interval Upper limit Calculated Net 95% Confidence Interval Lower Limit Calculated Net 95% Confidence Interval Upper Limit
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Comparison Measure Fructose vs. Glucose


Enter a numeric value or title (required) years

N Analyzed 10 10 0.975
Unit % Signal % Signal 0.01
Baseline 1.32 1.59 0.07
Delta +0.45 +0.52 -0.98
Baseline Standard Error 0.29 0.26 0.96
Delta Standard Error 0.30 0.34 -0.959
0.819


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] Yes
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2) Was the treatment allocation concealed? Yes
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3) Was the patient blinded to the intervention? [Yes, No, Unsure] Yes
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4) Was the care provider blinded to the intervention? [Yes, No, Unsure] No
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5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] Yes lab personnel and radiologist
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6) Was the dropout rate described and acceptable? [Yes, No, Unsure] 20%
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7) Analyzed in the group to which they were allocated? [Yes, No, Unsure] No
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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] Yes
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10) Were co-interventions avoided or similar? [Yes, No, Unsure] Yes
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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] No
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Quality Rating
Guideline Used Overall Rating
High