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Study Title and Description

Effect of fructose overfeeding and fish oil administration on hepatic de novo lipogenesis and insulin sensitivity in healthy men.



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 Effect of fructose overfeeding and fish oil administration on hepatic de novo lipogenesis and insulin sensitivity in healthy men.
Author Faeh D., Minehira K., Schwarz JM., Periasamy R., Periasami R., Park S., Seongsu P., Tappy L.
Country Department of Physiology, University of Lausanne, Lausanne, Switzerland.
Year 2005
Numbers Pubmed ID: 15983189
1334 (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 Fructose
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2 Healthy/Isocaloric diet
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Randomized Control Trial (crossover)
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source Grant from Swiss National Science Foundation and Nutricia Research Foundation
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Inclusion Criteria -healthy males -non smokers -no medication
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Exclusion Criteria -Family history of diabetes
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Location Switzerland
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Fructose Healthy/Isocaloric diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 7 (crossover) 7 (crossover) 7
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N Analyzed 7 (crossover) 7 (crossover) 7 (crossover)
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Mean (SD) Age, yrs nd
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Age range (IQR) 22-31
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Male % 100%
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Anthropometry data BMI 20.2-25.4
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Body Weight 71.5 +/- 4.0
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% Body Fat 16.5% +/- 0.7
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Alcohol Intake nd
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Co-morbidity (other diseases/conditions) none
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Other important baseline characteristics or baseline confounders nd
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Background Diet "a balance, isoenergetic diet"
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3-day food diary
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nd
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n/a
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15% protein, 35% far, 50% carbohydrate
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Race/Ethnicity nd
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Results & Comparisons


Results Data
N Analyzed P-Value
Outcome: Hepatic de novo lipogenesis (DNL)      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Healthy/Isocaloric diet Comparison Measure ERROR vs. ERROR


0 N/A

Value 7 (crossover)
N Analyzed 7 (crossover) 7 (crossover) <0.05
Final Value 9.4 1.6
Final Standard Deviation 2.8 0.34
Unit % %
Crude or Adjusted Analysis crude crude

Adverse Events
Arm or Total Title Description Comments
Fructose Not Reported
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Healthy/Isocaloric diet
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
N Analyzed P-Value
Outcome: Hepatic de novo lipogenesis (DNL)      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Healthy/Isocaloric diet Comparison Measure ERROR vs. ERROR


0 N/A

Value 7 (crossover)
N Analyzed 7 (crossover) 7 (crossover) <0.05
Final Value 9.4 1.6
Final Standard Deviation 2.8 0.34
Unit % %
Crude or Adjusted Analysis crude crude


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] No
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2) Was the treatment allocation concealed? No
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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
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5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] No
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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] Yes
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10) Were co-interventions avoided or similar? [Yes, No, Unsure] Yes similar
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11) Was the compliance acceptable (greater than 80%) in all groups? [Yes, No, Unsure] Yes
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12) Was the timing of the outcome assessment similar in all groups? [Yes, No, Unsure] No some were 6 days, others 28 days. 12 week wash out period
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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