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Study Title and Description

Diets high in glucose or sucrose and young women.



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 Diets high in glucose or sucrose and young women.
Author Kelsay JL., Behall KM., Holden JM., Prather ES.
Country -- Not Found --
Year 1974
Numbers Pubmed ID: 4412810
1380 (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
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2 Glucose
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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 nd
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Inclusion Criteria -healthy women -presumably students at the University of Maryland
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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 Glucose Healthy/Isocaloric diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 8 (crossover)
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N Analyzed 8 (crossover)
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Mean (SD) Age, yrs nd
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Age range (IQR) 18-23 yrs
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Male % 0%
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Anthropometry data Body Weight Range of 43.6-65.3 kg in weight
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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 Diets composed mainly of ordinary foods and supplemented with vitamins and minerals to meet the RDA.
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food was weighed and meals prepared and served by members of research team.
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nd
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nd
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About 2000 kcal/d, adjusted individually to maintain body weight. 38% of total calories from fat, 12% from protein, and 50% from carbohydrate. 15% of carb from fruits and vegetables, and remaining 85% from glucose, sucrose, or a mix of sugars and starches.
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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: ALP      Population: All Participants Between-Arm Comparisons
Time Point Measure Sucrose Glucose Healthy/Isocaloric diet Comparison Measure Sucrose vs. Glucose


0 N/A

Counts 8 (crossover)
Baseline Value 32 32 nd
Baseline Standard Error 4 4 nd
Final 32 29 nd
Final Standard Error 3 3 nd
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
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 Glucose Healthy/Isocaloric diet Comparison Measure Sucrose vs. Glucose


0 N/A

Counts 8 (crossover)
Baseline Value 8.6 8.0 nd
Baseline Standard Error 1 0.3 nd
Final 7.9 8.1 nd
Final Standard Error 0.4 0.3 nd
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
Comments
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 Glucose Healthy/Isocaloric diet Comparison Measure Glucose vs. Healthy/Isocaloric diet


0 N/A

Counts 8 (crossover)
Baseline Value 5.0 5.5 nd
Baseline Standard Error 0.5 0.6 nd
Final 4.3 4.1 nd
Final Standard Error 0.3 0.3 <0.001
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
Comments

Adverse Events
Arm or Total Title Description Comments
Sucrose Not Reported
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Glucose
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 Glucose Healthy/Isocaloric diet Comparison Measure Sucrose vs. Glucose


0 N/A

Counts 8 (crossover)
Baseline Value 32 32 nd
Baseline Standard Error 4 4 nd
Final 32 29 nd
Final Standard Error 3 3 nd
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
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 Glucose Healthy/Isocaloric diet Comparison Measure Sucrose vs. Glucose


0 N/A

Counts 8 (crossover)
Baseline Value 8.6 8.0 nd
Baseline Standard Error 1 0.3 nd
Final 7.9 8.1 nd
Final Standard Error 0.4 0.3 nd
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
Comments
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 Glucose Healthy/Isocaloric diet Comparison Measure Glucose vs. Healthy/Isocaloric diet


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Counts 8 (crossover)
Baseline Value 5.0 5.5 nd
Baseline Standard Error 0.5 0.6 nd
Final 4.3 4.1 nd
Final Standard Error 0.3 0.3 <0.001
Unit mU/ml mU/ml mU/ml
N Analyzed 8 (crossover) 8 (crossover) 8 (crossover)
Comments


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
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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] 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] No Data but assumed good compliance due to weighting food
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12) Was the timing of the outcome assessment similar in all groups? [Yes, No, Unsure] No
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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
Medium