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Study Title and Description

The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit.



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 The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit.
Author Purkins L., Love ER., Eve MD., Wooldridge CL., Cowan C., Smart TS., Johnson PJ., Rapeport WG.
Country Pfizer Global Research & Development, Pfizer Ltd., Ramsgate Road, Sandwich, Kent CT13 9NJ, UK. Lynn_Purkins@sandwich.pfizer.com
Year 2004
Numbers Pubmed ID: 14748819
1335 (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 Sucrose High carbohydrate, high calorie, 32% sucrose
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2 High Fat High Calorie
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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 Unclear but the authors thank the staff at the Pfizer Research Clinic
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Inclusion Criteria -healthy males -laboratory profiles within acceptable ranges BMI 18-28 -smoking <5 cigarettes/d -drinking <21 units alcohol/wk -no medications or unaccustomed exercise for at least 3 weeks prior to study
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Exclusion Criteria nd
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Location UK
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Sucrose High Fat High Calorie Healthy/Isocaloric diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 12
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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
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Mean (SD) Age, yrs nd
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Age range (IQR) 20-41
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Male % 100%
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Anthropometry data No data entered.
Alcohol Intake <21 units alcohol/wk
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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 A dietary history
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n/a
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n/a
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"satisfactory and not malnourished"
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Usual diet
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Race/Ethnicity nd
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Results & Comparisons


Results Data
Outcome: ALP      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


0 N/A

N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +6% +8%
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 1% 3%
Final Value 84.3 78.0 79.9 95% Confidence Interval Upper Limit (95% HCI) 11% 13%
Final Standard Deviation 25.5 22.2 24.3 P-Value 0.007 0.003
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +143 +76
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 79 29
Final Value 103.8 51.8 56.8 95% Confidence Interval Upper Limit (95% HCI) 231 139
Final Standard Deviation 63.3 13.0 30.2 P-Value <0.001 <0.001
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +90 +57
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 48 22
Final Value 56.8 33.3 27.4 95% Confidence Interval Upper Limit (95% HCI) 145 103
Final Standard Deviation 30.2 6.7 4.6 P-Value 0.13 <0.001
Outcome: GGT      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +45 +32
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 26% 15%
Final Value 39.8 28.7 26.5 95% Confidence Interval Upper Limit (95% HCI) 70% 51%
Final Standard Deviation 15.8 4.0 7.0 P-Value <0.001 <0.001
Outcome: Bilirubin      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit umol/L umol/L umol/L Mean Difference (Net) nd nd
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) -35 -8
Final Value 6.46 6.01 8.47 95% Confidence Interval Upper Limit (95% HCI) 12 23
Final Standard Deviation 2.00 1.66 2.44 P-Value <0.001 ns

Adverse Events
Arm or Total Title Description Comments
Sucrose Not Reported
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High Fat High Calorie
Healthy/Isocaloric diet
Total

Extraction Form: Intervention Studies Quality


Results & Comparisons


Results Data
Outcome: ALP      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +6% +8%
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 1% 3%
Final Value 84.3 78.0 79.9 95% Confidence Interval Upper Limit (95% HCI) 11% 13%
Final Standard Deviation 25.5 22.2 24.3 P-Value 0.007 0.003
Outcome: ALT      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +143 +76
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 79 29
Final Value 103.8 51.8 56.8 95% Confidence Interval Upper Limit (95% HCI) 231 139
Final Standard Deviation 63.3 13.0 30.2 P-Value <0.001 <0.001
Outcome: AST      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +90 +57
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 48 22
Final Value 56.8 33.3 27.4 95% Confidence Interval Upper Limit (95% HCI) 145 103
Final Standard Deviation 30.2 6.7 4.6 P-Value 0.13 <0.001
Outcome: GGT      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit U/L U/L U/L Mean Difference (Net) +45 +32
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) 26% 15%
Final Value 39.8 28.7 26.5 95% Confidence Interval Upper Limit (95% HCI) 70% 51%
Final Standard Deviation 15.8 4.0 7.0 P-Value <0.001 <0.001
Outcome: Bilirubin      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose High Fat High Calorie Healthy/Isocaloric diet Comparison Measure Sucrose vs. Healthy/Isocaloric diet Sucrose vs. High Fat High Calorie


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N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) N Analyzed 12 (crossover) 12 (crossover)
Unit umol/L umol/L umol/L Mean Difference (Net) nd nd
Crude or Adjusted Analysis Crude Crude Crude 95% Confidence Interval Lower Limit (95% LCI) -35 -8
Final Value 6.46 6.01 8.47 95% Confidence Interval Upper Limit (95% HCI) 12 23
Final Standard Deviation 2.00 1.66 2.44 P-Value <0.001 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] 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] No
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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
High