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Study Title and Description

Effects of a short-term overfeeding with fructose or glucose in healthy young males



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 a short-term overfeeding with fructose or glucose in healthy young males
Author Ngo Sock et al.
Country
Year 2010
Numbers 447 (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 Glucose
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3 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 Swiss National Foundation for Science
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Inclusion Criteria -healthy -nonsmoking -moderately physically active -BMI between 19 and 25
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Exclusion Criteria -taking medication -regularly consuming alcohol or 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 Glucose Healthy/Isocaloric diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 11
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N Analyzed 11
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Mean (SD) Age, yrs 24.6 (SE 0.6)
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Age range (IQR) nd
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Male % 100
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Anthropometry data BMI BMI between 19 and 25
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Alcohol Intake nd
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Co-morbidity (other diseases/conditions) no comorbidities
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Other important baseline characteristics or baseline confounders nd
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Background Diet Weight maintenance diet
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n/a
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n/a
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n/a
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Total energy intake = predicted basal energy requirement x 1.6, containing 55% carbohydrate (of which 11% simple sugar), 30% fat and 15% protein
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Race/Ethnicity nd
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Results & Comparisons


Results Data
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


0 N/A

N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover)
Unit mmol/kg ww mmol/kg ww mmol/kg ww +52% +58%
Final Value 2.4 2.35 2.1 13% 23%
Final Standard Error nd nd nd <0.05 <0.05
29% 29%
203% 266%
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


0 N/A

Counts 11 (crossover) 11 (crossover)
Unit U/l U/l U/l +4 +5
N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) nd nd
Final Value 25 26 21 ns ns
Final Standard Error 3 4 2 nd nd
nd nd
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


0 N/A

N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover)
Unit U/l U/l U/l +1 +1
Final Value 25 25 24 nd nd
Final Standard Error 1 2 1 ns nd
nd nd
nd nd

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

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


0 N/A

N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover)
Unit mmol/kg ww mmol/kg ww mmol/kg ww +52% +58%
Final Value 2.4 2.35 2.1 13% 23%
Final Standard Error nd nd nd <0.05 <0.05
29% 29%
203% 266%
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


0 N/A

Counts 11 (crossover) 11 (crossover)
Unit U/l U/l U/l +4 +5
N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) nd nd
Final Value 25 26 21 ns ns
Final Standard Error 3 4 2 nd nd
nd nd
N Analyzed Mean Difference (Net) Standard Error P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Healthy/Isocaloric diet Comparison Measure Fructose vs. Healthy/Isocaloric diet Glucose vs. Healthy/Isocaloric diet


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N Analyzed 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover) 11 (crossover)
Unit U/l U/l U/l +1 +1
Final Value 25 25 24 nd nd
Final Standard Error 1 2 1 ns nd
nd nd
nd nd


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 Data
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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 assessed but not reported
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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 exact total amount not ascertained
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Quality Rating
Guideline Used Overall Rating
Medium