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Study Title and Description

Markedly blunted metabolic effects of fructose in healthy young female subjects compared with male subjects.



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 Markedly blunted metabolic effects of fructose in healthy young female subjects compared with male subjects.
Author Couchepin C., Lê KA., Bortolotti M., da Encarnaçao JA., Oboni JB., Tran C., Schneiter P., Tappy L.
Country Department of Physiology, Lausanne University School of Biology and Medicine, Lausanne, Switzerland.
Year 2008
Numbers Pubmed ID: 18332156
729 (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 (Males)
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2 Fructose (Females)
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3 Healthy/Isocaloric (Males)
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4 Healthy/Isocaloric (Females)
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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 Swiss National Science Foundation
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Inclusion Criteria -healthy, nonsmoking Caucasian males -not taking any medications (except oral contraception for women)
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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 (Males) Fructose (Females) Healthy/Isocaloric (Males) Healthy/Isocaloric (Females) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 8 8 8 8 16
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N Analyzed 8 8 8 8 16
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Mean (SD) Age, yrs Male 22.5 (0.93); Female 22.9 (0.62)
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Age range (IQR) nd
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Male % 50%
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Anthropometry data BMI 22.5 (1.4) BMI 21.0 (1.4)
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% Body Fat 14.2 (3.1) % Body Fat 24.6 (2.5)
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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 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 100% Caucasian
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Results & Comparisons


Results Data
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (Males) Fructose (Females) Healthy/Isocaloric (Males) Healthy/Isocaloric (Females) Comparison Measure Fructose (Males) vs. Healthy/Isocaloric (Males) Fructose (Females) vs. Healthy/Isocaloric (Females)


0 N/A

N Analyzed 8 (crossover) 8 (crossover) 8 (crossover) 8 (crossover) N Analyzed 8 8
Unit U/I U/I U/I U/I Mean Difference (Net) +3.00 -0.88
Final 10.88 4.50 7.88 5.38 95% Confidence Interval Lower Limit (95% LCI) nd nd
Final SD 4.63 1.72 3.08 1.83 95% Confidence Interval Upper Limit (95% HCI) nd nd
P-Value <0.05 ns

Adverse Events
Arm or Total Title Description Comments
Fructose (Males) Not Reported
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Fructose (Females)
Healthy/Isocaloric (Males)
Healthy/Isocaloric (Females)
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (Males) Fructose (Females) Healthy/Isocaloric (Males) Healthy/Isocaloric (Females) Comparison Measure Fructose (Males) vs. Healthy/Isocaloric (Males) Fructose (Females) vs. Healthy/Isocaloric (Females)


0 N/A

N Analyzed 8 (crossover) 8 (crossover) 8 (crossover) 8 (crossover) N Analyzed 8 8
Unit U/I U/I U/I U/I Mean Difference (Net) +3.00 -0.88
Final 10.88 4.50 7.88 5.38 95% Confidence Interval Lower Limit (95% LCI) nd nd
Final SD 4.63 1.72 3.08 1.83 95% Confidence Interval Upper Limit (95% HCI) nd nd
P-Value <0.05 ns


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 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] 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] 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] 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
Medium