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Study Title and Description

Fructose overconsumption causes dyslipidemia and ectopic lipid deposition in healthy subjects with and without a family history of type 2 diabetes.



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 Fructose overconsumption causes dyslipidemia and ectopic lipid deposition in healthy subjects with and without a family history of type 2 diabetes.
Author Lê KA., Ith M., Kreis R., Faeh D., Bortolotti M., Tran C., Boesch C., Tappy L.
Country Department of Physiology, University of Lausanne, Lausanne, Switzerland.
Year 2009
Numbers Pubmed ID: 19403641
526 (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 (offT2D) Offspring of DMII
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2 Healthy/Isocaloric (offTD2) Offspring of DMII
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3 Fructose (Controls)
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4 Healthy/Isocaloric (Controls)
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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 July, 2006
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Trial or Cohort Name nd
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Funding Source -Grants from Swiss National Science Foundation and Novartis Foundation -Takeda Pharmaceuticals
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Inclusion Criteria -Healthy offspring of patients with type 2 diabetes (excluding controls) -BMI between 19-25 -Moderately physically active (<1/wk) -Controls matched for age, BMI and total body fat. Also good health and were moderately physically active (<1/wk)
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Exclusion Criteria -smoker -Medications -regular consumption of alcohol -regular consumption of sugar-sweetened beverages
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Location Switzerland
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Fructose (offT2D) Healthy/Isocaloric (offTD2) Fructose (Controls) Healthy/Isocaloric (Controls) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 24
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N Analyzed 16 (crossover) 16 (crossover) 8 (crossover) 8 (crossover) 24
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Mean (SD) Age, yrs 24.7 (SEM ±1.3 yr) (controls: 24 SEM ±1 yr)
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Age range (IQR) nd
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Male % 100%
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Anthropometry data BMI 19-25
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Alcohol Intake nd Subjects did not "regularly consume" alcohol
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Co-morbidity (other diseases/conditions) None
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Other important baseline characteristics or baseline confounders Each subject had at least one parent with type 2 diabetes. Controls were not offspring of patient with type 2 diabetes
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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
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Net Difference
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (offT2D) Healthy/Isocaloric (offTD2) Fructose (Controls) Healthy/Isocaloric (Controls) Comparison Measure Fructose (offT2D) vs. Healthy/Isocaloric (offTD2) Fructose (Controls) vs. Healthy/Isocaloric (Controls)


0 N/A

N Analyzed 16 (crossover 16 (crossover) 8 (crossover) 8 (crossover) nd nd
Units (volume %) (volume %) (volume %) (volume %) nd nd
Baseline Value nd nd nd nd <0.05 <0.05
Baseline Standard Error nd nd nd nd +0.7 +0.35
Final Value 1.6 0.9 0.8 nd
Final Standard Error nd nd 0.45 nd
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Net Difference
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (offT2D) Healthy/Isocaloric (offTD2) Fructose (Controls) Healthy/Isocaloric (Controls) Comparison Measure Fructose (offT2D) vs. Healthy/Isocaloric (offTD2) Fructose (Controls) vs. Healthy/Isocaloric (Controls)


0 N/A

N Analyzed 16 (crossover) 16 (crossover) 8 (crossover) 8 (crossover) nd nd
Units U/L U/L U/L U/L nd nd
Baseline Value nd nd nd nd <0.05 <0.05
Baseline Standard Error nd nd nd nd +12.9 +8.0
Final Value 29.3 16.4 24.9 16.9
Final Standard Error 4.2 1.0 4.2 1.2

Adverse Events
Arm or Total Title Description Comments
Fructose (offT2D) Not Reported
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Healthy/Isocaloric (offTD2)
Fructose (Controls)
Healthy/Isocaloric (Controls)
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Net Difference
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (offT2D) Healthy/Isocaloric (offTD2) Fructose (Controls) Healthy/Isocaloric (Controls) Comparison Measure Fructose (offT2D) vs. Healthy/Isocaloric (offTD2) Fructose (Controls) vs. Healthy/Isocaloric (Controls)


0 N/A

N Analyzed 16 (crossover 16 (crossover) 8 (crossover) 8 (crossover) nd nd
Units (volume %) (volume %) (volume %) (volume %) nd nd
Baseline Value nd nd nd nd <0.05 <0.05
Baseline Standard Error nd nd nd nd +0.7 +0.35
Final Value 1.6 0.9 0.8 nd
Final Standard Error nd nd 0.45 nd
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Net Difference
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (offT2D) Healthy/Isocaloric (offTD2) Fructose (Controls) Healthy/Isocaloric (Controls) Comparison Measure Fructose (offT2D) vs. Healthy/Isocaloric (offTD2) Fructose (Controls) vs. Healthy/Isocaloric (Controls)


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N Analyzed 16 (crossover) 16 (crossover) 8 (crossover) 8 (crossover) nd nd
Units U/L U/L U/L U/L nd nd
Baseline Value nd nd nd nd <0.05 <0.05
Baseline Standard Error nd nd nd nd +12.9 +8.0
Final Value 29.3 16.4 24.9 16.9
Final Standard Error 4.2 1.0 4.2 1.2


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] No Data
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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 Additional fructose solution, no placebo
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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 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] No Data
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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 ranges of washout 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 do not know compliance. If all complied, yes, you know because meals prepackaged and fructose supplement measured.
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Quality Rating
Guideline Used Overall Rating
High