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Study Title and Description

Low to moderate sugar-sweetened beverage consumption impairs glucose and lipid metabolism and promotes inflammation in healthy young men: a randomized controlled trial



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 Low to moderate sugar-sweetened beverage consumption impairs glucose and lipid metabolism and promotes inflammation in healthy young men: a randomized controlled trial
Author Aeberli et al.
Country
Year 2011
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Fructose and NAFLD
Arms
Number Title Description Comments
1 High Fructose, 80g
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2 High Glucose, 80g
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3 High sucrose, 80g
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4 Medium Fructose, 40g
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5 Medium Glucose. 40g
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6 low fructose avoiding free fructose and sweetened products
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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 2007- 2010
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Trial or Cohort Name nd
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Funding Source Swiss National Science Foundation, Nestle provided beverages for the study
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Inclusion Criteria -healthy, normal-weight males (BMI between 19 and 25, age between 20 and 50 y) -living in the region of Zurich
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Exclusion Criteria -taking regular medication -consuming sugar-sweetened beverages with a total content of >60 g carbohydrates/day
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Location Switzerland
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question High Fructose, 80g High Glucose, 80g High sucrose, 80g Medium Fructose, 40g Medium Glucose. 40g low fructose Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 29
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N Analyzed 26 25 27 26 25 26
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Mean (SD) Age, yrs 26.3 (6.6)
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Age range (IQR) nd
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Male % 100%
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Anthropometry data BMI 73.7 (8.8)
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Body Weight 22.4 (1.9)
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% Body Fat 15.4 (3.1)
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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 Dietary Fructose, Sucrose, or Glucose
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weighted food record
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EBISpro for Windows 8.0, Dr. J Erhardt, University of Hohenheim, Germany
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no
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Total fructose 48.4 (23) Free fructose 16.1 (9.0) Total energy (kcal/d) 2329 (523)
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Race/Ethnicity nd (presumably mostly white)
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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: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure High Fructose, 80g High Glucose, 80g High sucrose, 80g Medium Fructose, 40g Medium Glucose. 40g low fructose Comparison Measure Medium Fructose, 40g vs. High Fructose, 80g vs. Medium Glucose. 40g vs. High Glucose, 80g vs. High sucrose, 80g vs. low fructose


0 N/A

N Analyzed 26 25 27 26 25 26 nd
Unit U/L U/L U/L U/L U/L U/L nd
Baseline Value 26 26 26 26 26 26 nd
Baseline Standard Deviation 6 6 6 6 6 6 nd
Final Value 27 28 29 27 28 28
Final Standard Deviation 8 6 9 6 7 7

Adverse Events
Arm or Total Title Description Comments
High Fructose, 80g Not Reported
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High Glucose, 80g
High sucrose, 80g
Medium Fructose, 40g
Medium Glucose. 40g
low fructose
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: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure High Fructose, 80g High Glucose, 80g High sucrose, 80g Medium Fructose, 40g Medium Glucose. 40g low fructose Comparison Measure Medium Fructose, 40g vs. High Fructose, 80g vs. Medium Glucose. 40g vs. High Glucose, 80g vs. High sucrose, 80g vs. low fructose


0 N/A

N Analyzed 26 25 27 26 25 26 nd
Unit U/L U/L U/L U/L U/L U/L nd
Baseline Value 26 26 26 26 26 26 nd
Baseline Standard Deviation 6 6 6 6 6 6 nd
Final Value 27 28 29 27 28 28
Final Standard Deviation 8 6 9 6 7 7


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] Yes
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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] Yes double blinded
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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] Yes
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6) Was the dropout rate described and acceptable? [Yes, No, Unsure] Yes 5 of 29 dropped out
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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] Not Applicable (crossover)
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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] Yes
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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] Yes
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Quality Rating
Guideline Used Overall Rating
Low