• Home
  • Published Projects
  • Registries
Advanced Search

Study Preview



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?
  • Comments Comments (
    0
    ) |
  • Post/View
3 Risk of Bias - RCTs and non-RCT
  • Comments Comments (
    0
    ) |
  • Post/View

Primary Publication Information
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
2 High Fat High Calorie
  • Comments Comments (
    0
    ) |
3 Healthy/Isocaloric diet
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Randomized Control Trial (crossover)
  • Comments Comments (
    0
    ) |
Enrollment Years nd
  • Comments Comments (
    0
    ) |
Trial or Cohort Name nd
  • Comments Comments (
    0
    ) |
Funding Source Unclear but the authors thank the staff at the Pfizer Research Clinic
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Exclusion Criteria nd
  • Comments Comments (
    0
    ) |
Location UK
  • Comments Comments (
    0
    ) |
Counfounders No (Skip question #10)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Sucrose High Fat High Calorie Healthy/Isocaloric diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 12
  • Comments Comments (
    0
    ) |
N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
  • Comments Comments (
    0
    ) |
Mean (SD) Age, yrs nd
  • Comments Comments (
    0
    ) |
Age range (IQR) 20-41
  • Comments Comments (
    0
    ) |
Male % 100%
  • Comments Comments (
    0
    ) |
Anthropometry data No data entered.
Alcohol Intake <21 units alcohol/wk
  • Comments Comments (
    0
    ) |
Co-morbidity (other diseases/conditions) nd
  • Comments Comments (
    0
    ) |
Other important baseline characteristics or baseline confounders nd
  • Comments Comments (
    0
    ) |
Background Diet A dietary history
  • Comments Comments (
    0
    ) |
n/a
  • Comments Comments (
    0
    ) |
n/a
  • Comments Comments (
    0
    ) |
"satisfactory and not malnourished"
  • Comments Comments (
    0
    ) |
Usual diet
  • Comments Comments (
    0
    ) |
Race/Ethnicity nd
  • Comments Comments (
    0
    ) |



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: 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) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +6% +8%
Crude or Adjusted Analysis Crude Crude Crude 1% 3%
Final Value 84.3 78.0 79.9 11% 13%
Final Standard Deviation 25.5 22.2 24.3 0.007 0.003
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +143 +76
Crude or Adjusted Analysis Crude Crude Crude 79 29
Final Value 103.8 51.8 56.8 231 139
Final Standard Deviation 63.3 13.0 30.2 <0.001 <0.001
N Analyzed 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 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) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +90 +57
Crude or Adjusted Analysis Crude Crude Crude 48 22
Final Value 56.8 33.3 27.4 145 103
Final Standard Deviation 30.2 6.7 4.6 0.13 <0.001
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +45 +32
Crude or Adjusted Analysis Crude Crude Crude 26% 15%
Final Value 39.8 28.7 26.5 70% 51%
Final Standard Deviation 15.8 4.0 7.0 <0.001 <0.001
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit umol/L umol/L umol/L nd nd
Crude or Adjusted Analysis Crude Crude Crude -35 -8
Final Value 6.46 6.01 8.47 12 23
Final Standard Deviation 2.00 1.66 2.44 <0.001 ns

Adverse Events
Arm or Total Title Description Comments
Sucrose Not Reported
  • Comments Comments (
    0
    ) |
High Fat High Calorie
Healthy/Isocaloric diet
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: 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) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +6% +8%
Crude or Adjusted Analysis Crude Crude Crude 1% 3%
Final Value 84.3 78.0 79.9 11% 13%
Final Standard Deviation 25.5 22.2 24.3 0.007 0.003
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +143 +76
Crude or Adjusted Analysis Crude Crude Crude 79 29
Final Value 103.8 51.8 56.8 231 139
Final Standard Deviation 63.3 13.0 30.2 <0.001 <0.001
N Analyzed 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 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) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +90 +57
Crude or Adjusted Analysis Crude Crude Crude 48 22
Final Value 56.8 33.3 27.4 145 103
Final Standard Deviation 30.2 6.7 4.6 0.13 <0.001
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit U/L U/L U/L +45 +32
Crude or Adjusted Analysis Crude Crude Crude 26% 15%
Final Value 39.8 28.7 26.5 70% 51%
Final Standard Deviation 15.8 4.0 7.0 <0.001 <0.001
N Analyzed Mean Difference (Net) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
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


0 N/A

 N Analyzed 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover) 12 (crossover)
Unit umol/L umol/L umol/L nd nd
Crude or Adjusted Analysis Crude Crude Crude -35 -8
Final Value 6.46 6.01 8.47 12 23
Final Standard Deviation 2.00 1.66 2.44 <0.001 ns


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] No Data
  • Comments Comments (
    0
    ) |
2) Was the treatment allocation concealed? No Data
  • Comments Comments (
    0
    ) |
3) Was the patient blinded to the intervention? [Yes, No, Unsure] No
  • Comments Comments (
    0
    ) |
4) Was the care provider blinded to the intervention? [Yes, No, Unsure] No Data
  • Comments Comments (
    0
    ) |
5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] No Data
  • Comments Comments (
    0
    ) |
6) Was the dropout rate described and acceptable? [Yes, No, Unsure] 0
  • Comments Comments (
    0
    ) |
7) Analyzed in the group to which they were allocated? [Yes, No, Unsure] Yes
  • Comments Comments (
    0
    ) |
8) Are reports of the study free of suggestion of selective outcome reporting? [Yes, No, Unsure] No
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
10) Were co-interventions avoided or similar? [Yes, No, Unsure] No
  • Comments Comments (
    0
    ) |
11) Was the compliance acceptable (greater than 80%) in all groups? [Yes, No, Unsure] No Data
  • Comments Comments (
    0
    ) |
12) Was the timing of the outcome assessment similar in all groups? [Yes, No, Unsure] Yes
  • Comments Comments (
    0
    ) |
13) Was the total fructose intake (including intervention dose and background fructose intake from diet) measured? [Yes, No, Unsure] No
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating
High