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Study Title and Description

Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study.



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 Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study.
Author Maersk M., Belza A., Stødkilde-Jørgensen H., Ringgaard S., Chabanova E., Thomsen H., Pedersen SB., Astrup A., Richelsen B.
Country Department of Endocrinology and Internal Medicine MEA, Aarhus University Hospital, Denmark.
Year 2012
Numbers Pubmed ID: 22205311

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


Extraction Form: Fructose and NAFLD
Arms
Number Title Description Comments
1 Sucrose
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2 Water
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Randomized Control Trial (parallel)
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source The Danish Council for Strategic Research, the Food study Group/Danish Ministry of Food, Agriculture and Fishers, Novo Nordic Foundation, CLiinical Institute at Aarhus University, Arla Foods
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Inclusion Criteria Nondiabetic BMI b/w 26 and 40 kg/m2 age b/w 20 and 50 y blood pressure <160/100 mm Hg
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Exclusion Criteria nd
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Location Denmark
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Confounders No
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Yes
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Age, Sex
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No
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No
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No
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No
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Yes
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No
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No
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Physical Activity
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Counfounders Yes
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Baseline Characteristics
Question Sucrose Water Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 60
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N Analyzed 10 13 47
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Mean (SD) Age, yrs 38.7
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Age range (IQR) 20-50
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Male % 37
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Anthropometry data BMI 32
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Body Weight 96.6 kg
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Alcohol Intake Usual amount of alcohol
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Co-morbidity (other diseases/conditions) Some hypertension
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Other important baseline characteristics or baseline confounders Age, sex, baseline beverages consumption, physical activity
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Background Diet Usual diet, monitored at baseline, after 3 mo, and at the end of the intervention
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7-day dietary record
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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
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose Water Comparison Measure Sucrose vs. Water


0 N/A

N Analyzed 10 13 N Analyzed 23
Unit Arbitrary Arbitrary Mean Difference (Net) +132%
Baseline Value 0.037 0.127 95% Confidence Interval Lower Limit (95% LCI) 44%
Baseline Standard Deviation 0.04 0.1 95% Confidence Interval Upper Limit (95% HCI) 222%
Final Value nd nd P-Value <0.05
Final Standard Deviation nd nd

Adverse Events
Arm or Total Title Description Comments
Sucrose Not Reported
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Water
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
Outcome: IHCL      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose Water Comparison Measure Sucrose vs. Water


0 N/A

N Analyzed 10 13 N Analyzed 23
Unit Arbitrary Arbitrary Mean Difference (Net) +132%
Baseline Value 0.037 0.127 95% Confidence Interval Lower Limit (95% LCI) 44%
Baseline Standard Deviation 0.04 0.1 95% Confidence Interval Upper Limit (95% HCI) 222%
Final Value nd nd P-Value <0.05
Final Standard Deviation nd nd


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
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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
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5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] No
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6) Was the dropout rate described and acceptable? [Yes, No, Unsure] 22%
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7) Analyzed in the group to which they were allocated? [Yes, No, Unsure] No
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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] Yes
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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] Yes
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Quality Rating
Guideline Used Overall Rating
High