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Study Title and Description

Consuming fructose-sweetened, not glucose-sweetened, beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans.



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 Consuming fructose-sweetened, not glucose-sweetened, beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans.
Author Stanhope KL., Schwarz JM., Keim NL., Griffen SC., Bremer AA., Graham JL., Hatcher B., Cox CL., Dyachenko A., Zhang W., McGahan JP., Seibert A., Krauss RM., Chiu S., Schaefer EJ., Ai M., Otokozawa S., Nakajima K., Nakano T., Beysen C., Hellerstein MK., Berglund L., Havel PJ.
Country Department of Molecular Biosciences, UCD, Davis, California 95616, USA.
Year 2009
Numbers Pubmed ID: 19381015
542 (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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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Randomized Control Trial (parallel)
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Enrollment Years 10 Weeks – nd for Year
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Trial or Cohort Name nd
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Funding Source NIH Grant
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Inclusion Criteria -Age 40-72 -BMI 25-35 with self report of stable body weight during the prior 6 months. -women were post menopausal based on self report
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Exclusion Criteria -Evidence of diabetes, renal disease, or hepatic disease -fasting TG concentrations greater than 400 -hypertension >140/90mmHg -history of surgery for weight loss -smoking -Reported exercise of more than 3.5 hours/wk at a level more vigorous than walking -Report of having used thyroid, lipid lowering, glucose lowering, antihypertensive, antidepressant, or weight-loss medications -habitual ingestion of more than 1 sugar sweetened beverage per day or more than 2 alcoholic beverages per day
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Location USA
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Confounders Yes
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Fat, sugar, and alcohol as % of energy req.
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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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Yes
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Alcohol intake
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No
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No
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No
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Counfounders Yes
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Baseline Characteristics
Question Fructose Glucose Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 39
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N Analyzed 10 8 18 (31 analyzed, but only 18 for DNL outcome)
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Mean (SD) Age, yrs Males (n=7): Age : 54.3 ± 3 Females (n=8): Age : 56 ± 2 Males (n=9): Age : 52 ± 4 Females (n=8): Age: 53 ± 2
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Age range (IQR) nd
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Male % 50%
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Anthropometry data BMI Fructose Males (n=9): BMI : 28.4 ± 0.7 Fructose Females (n=8): BMI : 30.3 ± 1.0 BMI Males (n=7): : 29.3 ± 1.1 Females (n=8): 29.4 ± 1.3
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Body Weight Fructose Males (n=9): Weight: 89.3 ± 2.9 Fructose Females (n=8): Body Weight Males (n=7): : 88.4 ± 2.9 kg Females (n=8): 84.0 ± 4.5 kg
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% Body Fat Fructose Males (n=9): % Body Fat Males (n=7): 29.4 ± 1.1 Females (n=8): 43.2 ± 1.5
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Alcohol Intake Less than 2 drinks per day
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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 Fructose or glucose intake from beverages in addition to diet.
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24 hour recall via telephone using USDA 5 step multiple pass method. Recalls were done on 6 random days at weeks 2 and 7 of intervention
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Nutrition Data Systems for Research version 2005, University of Minnesota
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n/a
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Total Energy (kcal) Glucose Males (n=7): 2584 ± 52 Glucose Females (n=8): 2194 ± 83 Fructose Males (n=9): 2711 ± 109 Fructose Females (n=8): 2197 ± 78
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Race/Ethnicity nd
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Results & Comparisons


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


0 N/A

Unit % % 18
Baseline Value 9.9 8.8 nd
Baseline Standard Error 1.3 1.8 nd
Final Standard Error 0.9 1.8 nd
Final Value 8.3 9.5 nd
Final Delta Value -6.3 +12.3
Delta Standard Error 16.6 10.3
Outcome: Postprandial DNL      Population: All Participants
Time Point Measure Fructose Glucose


0 N/A

Unit % %
N Analyzed 10 8
Baseline Value 11.4 13.4
Baseline Standard Error 1.3 2.8
Final Standard Error 1.4 1.7
Final Value 16.9 14.2
Final Delta Value +75.4 +27.3
Delta Standard Error 25.6 13.6
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: 16 hour AUC DNL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Comparison Measure Fructose vs. Glucose


0 N/A

Unit % % 18
N Analyzed 10 8 nd
Baseline Value 21 54 nd
Baseline Standard Error 9 17 nd
Final Standard Error 19 8 0.016
Final Value 104 60
Final Delta Value nd nd
Delta Standard Error nd nd

Adverse Events
Arm or Total Title Description Comments
Fructose Not Reported
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Glucose
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


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


0 N/A

Unit % % 18
Baseline Value 9.9 8.8 nd
Baseline Standard Error 1.3 1.8 nd
Final Standard Error 0.9 1.8 nd
Final Value 8.3 9.5 nd
Final Delta Value -6.3 +12.3
Delta Standard Error 16.6 10.3
Outcome: Postprandial DNL      Population: All Participants
Time Point Measure Fructose Glucose


0 N/A

Unit % %
N Analyzed 10 8
Baseline Value 11.4 13.4
Baseline Standard Error 1.3 2.8
Final Standard Error 1.4 1.7
Final Value 16.9 14.2
Final Delta Value +75.4 +27.3
Delta Standard Error 25.6 13.6
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: 16 hour AUC DNL      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose Glucose Comparison Measure Fructose vs. Glucose


0 N/A

Unit % % 18
N Analyzed 10 8 nd
Baseline Value 21 54 nd
Baseline Standard Error 9 17 nd
Final Standard Error 19 8 0.016
Final Value 104 60
Final Delta Value nd nd
Delta Standard Error nd nd


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? Yes
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3) Was the patient blinded to the intervention? [Yes, No, Unsure] Yes
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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 double blind, but not specified who else was blind other than the participants
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6) Was the dropout rate described and acceptable? [Yes, No, Unsure] 46% (18/39)
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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] Yes
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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
Medium