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Study Title and Description

Diet-induced changes in serum transaminase and triglyceride levels in healthy adult men. Role of sucrose and excess calories.



Key Questions Addressed
2 What are the relationships between fructose consumption and indices of liver health?
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4 Risk of Bias - Cohort, Case-Control, and Single Arm Studies
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Primary Publication Information
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TitleData
Title Diet-induced changes in serum transaminase and triglyceride levels in healthy adult men. Role of sucrose and excess calories.
Author Porikos KP., Van Itallie TB.
Country -- Not Found --
Year 1983
Numbers Pubmed ID: 6624769
1377 (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 From sweetened foods in metabolic ward
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Single Arm Trial
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Enrollment Years nd
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Trial or Cohort Name nd
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Funding Source NIH, General Foods Corporation
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Inclusion Criteria -passed routine physical exam -normal levels of SGPT (45 units/liter or less) and SGOT (40 units/liter or less)
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Exclusion Criteria nd
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Location USA
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Counfounders No (Skip question #10)
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Baseline Characteristics
Question Sucrose Total Comments
AnswerFollow-up AnswerFollow-up
N Enrolled 21
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N Analyzed 16
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Mean (SD) Age, yrs nd
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Age range (IQR) 24-45
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Male % 100%
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Anthropometry data Body Weight 15 normal weight, 5 overweight (Tables of Desirable Weight of the Metropolitan life Insurance Company, 1959)
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Alcohol Intake nd
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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 Varied diet monitored in metabolic ward
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nd
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nd
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nd
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4,131 kcal/day Aspartame: 3,464 kcal/day
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Race/Ethnicity nd
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Results & Comparisons


Results Data
Outcome: ALT      Population: All Participants
Time Point Measure Sucrose


0 N/A

N Analyzed
Mean
Standard Deviation
Outcome: ALT      Population: Obese
Time Point Measure Sucrose


0 N/A

N Analyzed 5
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 48
Baseline Standard Error nd
Final Value 85
Final standard Error nd
Net Difference +37
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: ALT      Population: Nonobese
Time Point Measure Sucrose


0 N/A

N Analyzed 11
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 25
Baseline Standard Error nd
Final Value 39
Final standard Error nd
Net Difference +14
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: AST      Population: Obese
Time Point Measure Sucrose


0 N/A

N Analyzed 5
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 20
Baseline Standard Error nd
Final Value 38
Final standard Error nd
Net Difference +18
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: AST      Population: Nonobese
Time Point Measure Sucrose


0 N/A

N Analyzed 11
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 18
Baseline Standard Error nd
Final Value 25
Final standard Error nd
Net Difference +7
CI/SE for Net Difference nd
P value between groups <0.05

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

Extraction Form: Cohort, Case Control, Single Arm Quality


Results & Comparisons


Results Data
Outcome: ALT      Population: All Participants
Time Point Measure Sucrose


0 N/A

N Analyzed
Mean
Standard Deviation
Outcome: ALT      Population: Obese
Time Point Measure Sucrose


0 N/A

N Analyzed 5
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 48
Baseline Standard Error nd
Final Value 85
Final standard Error nd
Net Difference +37
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: ALT      Population: Nonobese
Time Point Measure Sucrose


0 N/A

N Analyzed 11
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 25
Baseline Standard Error nd
Final Value 39
Final standard Error nd
Net Difference +14
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: AST      Population: Obese
Time Point Measure Sucrose


0 N/A

N Analyzed 5
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 20
Baseline Standard Error nd
Final Value 38
Final standard Error nd
Net Difference +18
CI/SE for Net Difference nd
P value between groups <0.05
Outcome: AST      Population: Nonobese
Time Point Measure Sucrose


0 N/A

N Analyzed 11
Unit U/L
Crude or Adjusted Analysis crude
Baseline Value 18
Baseline Standard Error nd
Final Value 25
Final standard Error nd
Net Difference +7
CI/SE for Net Difference nd
P value between groups <0.05


Quality Dimensions
Dimension Value Notes Comments
1) Representativeness of the exposed cohort. b
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2) Ascertainment of nutrient exposure e
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3) Demonstration that outcome of interest was not present at start of the study a
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4) Description of a validated method to quantify the amount, per type, of nutrient of interest a
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5) Assessment of outcome d
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6) Was follow up long enough for outcomes to occur? b
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7) Adequacy of follow up of cohort c
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8) Analytic control for confounding (ANY confounders other than age and sex) a
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9) Analytic control for confounding: anthropomentrics b
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10) Analytic control for confounding: other nutrients a
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11) Power calculation to support sample size No
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Quality Rating
Guideline Used Overall Rating
High