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? | |
3 | Risk of Bias - RCTs and non-RCT |
Primary Publication Information
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 | |
2 | High Fat High Calorie | ||
3 | Healthy/Isocaloric diet |
Design Details
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Design | Randomized Control Trial (crossover) | ||
Enrollment Years | nd | ||
Trial or Cohort Name | nd | ||
Funding Source | Unclear but the authors thank the staff at the Pfizer Research Clinic | ||
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 | ||
Exclusion Criteria | nd | ||
Location | UK | ||
Counfounders | No (Skip question #10) |
Baseline Characteristics
Question | Sucrose | High Fat High Calorie | Healthy/Isocaloric diet | Total | Comments | ||||
---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
N Enrolled | 12 | ||||||||
N Analyzed | 12 (crossover) | 12 (crossover) | 12 (crossover) | 12 (crossover) | |||||
Mean (SD) Age, yrs | nd | ||||||||
Age range (IQR) | 20-41 | ||||||||
Male % | 100% | ||||||||
Anthropometry data | No data entered. | ||||||||
Alcohol Intake | <21 units alcohol/wk | ||||||||
Co-morbidity (other diseases/conditions) | nd | ||||||||
Other important baseline characteristics or baseline confounders | nd | ||||||||
Background Diet | A dietary history | ||||||||
n/a | |||||||||
n/a | |||||||||
"satisfactory and not malnourished" | |||||||||
Usual diet | |||||||||
Race/Ethnicity | nd |
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 |
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) | +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 |
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) | +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 |
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) | +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 |
0 N/A |
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 | ||
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 |
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 |
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) | +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 |
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) | +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 |
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) | +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 |
0 N/A |
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 | ||
2) Was the treatment allocation concealed? | No Data | ||
3) Was the patient blinded to the intervention? [Yes, No, Unsure] | No | ||
4) Was the care provider blinded to the intervention? [Yes, No, Unsure] | No Data | ||
5) Was the outcome assessor blinded to the intervention? [Yes, No, Unsure] | No Data | ||
6) Was the dropout rate described and acceptable? [Yes, No, Unsure] | 0 | ||
7) Analyzed in the group to which they were allocated? [Yes, No, Unsure] | Yes | ||
8) Are reports of the study free of suggestion of selective outcome reporting? [Yes, No, Unsure] | No | ||
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 | ||
10) Were co-interventions avoided or similar? [Yes, No, Unsure] | No | ||
11) Was the compliance acceptable (greater than 80%) in all groups? [Yes, No, Unsure] | No Data | ||
12) Was the timing of the outcome assessment similar in all groups? [Yes, No, Unsure] | Yes | ||
13) Was the total fructose intake (including intervention dose and background fructose intake from diet) measured? [Yes, No, Unsure] | No |
Quality Rating
Guideline Used | Overall Rating |
---|---|
High |