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Study Title and Description

Effects of short-term overfeeding with fructose, fat and fructose plus fat on plasma and hepatic lipids 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 Effects of short-term overfeeding with fructose, fat and fructose plus fat on plasma and hepatic lipids in healthy men
Author Sobrecases et al.
Country
Year 2010
Numbers Pubmed ID: 20483648

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 High Fat
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3 High Fructose & High Fat
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Nonrandomized Control Trial
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source Swiss National Foundation for Science
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Inclusion Criteria -healthy men -normal body mass index -no family history of diabetes, non-smokers, not taking any drugs or medications -(some subjects in the fructose and fat groups had been included in other studies, citing Le 2009 that is also included in this systematic review)
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Exclusion Criteria nd
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Location Switzerland
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Fructose High Fat High Fructose & High Fat Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 30
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N Analyzed 12 10 8 30
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Mean (SD) Age, yrs 23.9 +/- 0.4
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Age range (IQR) nd
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Male % 100%
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Anthropometry data BMI BMI 22.6 +/- 0.2
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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 nd
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Background Diet 7-day Isocaloric control diet
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n/a
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n/a
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n/a
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55% carbohydrate (10% simple sugars), 30% fat (10% saturated-fat) and 15% protein
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Race/Ethnicity nd
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Results & Comparisons


Results Data
Mean Difference (Net) 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 Fructose High Fat High Fructose & High Fat Comparison Measure High Fructose & High Fat vs. Fructose vs. High Fat


0 N/A

N Analyzed 12 10 8 nd
Unit nd nd nd nd
Baseline Value nd nd nd nd
Baseline Standard Error nd nd nd nd
Final Value nd nd nd
Final Standard Error nd nd 70%

Adverse Events
Arm or Total Title Description Comments
Fructose Not Reported
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High Fat
High Fructose & High Fat
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
Mean Difference (Net) 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 Fructose High Fat High Fructose & High Fat Comparison Measure High Fructose & High Fat vs. Fructose vs. High Fat


0 N/A

N Analyzed 12 10 8 nd
Unit nd nd nd nd
Baseline Value nd nd nd nd
Baseline Standard Error nd nd nd nd
Final Value nd nd nd
Final Standard Error nd nd 70%


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 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] No
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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 Data
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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] No
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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