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Study Title and Description

Effects of fructose feeding on blood parameters and blood pressure in impaired glucose-tolerant subjects.



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 Effects of fructose feeding on blood parameters and blood pressure in impaired glucose-tolerant subjects.
Author Koh ET., Ard NF., Mendoza F.
Country School of Human Development, University of Oklahoma, Norman.
Year 1988
Numbers Pubmed ID: 3294273
1363 (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 Fructose (IGTS) impaired glucose tolerant subjects
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2 Glucose (IGTS) impaired glucose tolerant subjects
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3 Fructose (NGTS Normal glucose tolerant subjects
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4 Glucose (NGTS) Normal glucose tolerant subjects
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Nonrandomized Control Trial
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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 -9 impaired glucose-tolerant subjects (IGTS) with 1 or 2 hr posprandial plasma glucose of 160-200 mg/dL. All subjects were outpatients at a private clinic and had well adhered to their dietary prescriptions before the study -able to comply with diet -IGTS treated by diet only -9 control subjects from university faculty and staff, matched by race, sex, and age (±5 years) with the selected patients. -control subjects not allowed to use medicine during study period.
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Exclusion Criteria -complications from renal and heart disease
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Location USA
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Confounders Self control (cross-over design)
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no
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no
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no
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no
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no
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no
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no
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no
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m/a
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Counfounders Yes
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Baseline Characteristics
Question Fructose (IGTS) Glucose (IGTS) Fructose (NGTS Glucose (NGTS) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
N Enrolled 9 (crossover) 9 (crossover) (9 crossover) 9 (crossover) 18
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N Analyzed 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover) 18
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Mean (SD) Age, yrs 54 (6) 50 (5)
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Age range (IQR) nd
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Male % 33%
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Anthropometry data Body Weight 164 (11) lbs Body Weight 145 (10)
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Other subscapular skinfold 22.7 (4.9) mm, triceps skinfold 19.5 (3.1) mm Other subscapular skinfold 14.2(1.2) mm, triceps skinfold 13.7(1.7) mm
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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 fructose intake Glucose intake fructose intake Glucose intake
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24-hr recall for 7 consecutive days 24-hr recall for 7 consecutive days 24-hr recall for 7 consecutive days 24-hr recall for 7 consecutive days
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Referenced to Koh, E.T. Comparison of dietary energy intakes and sources by race, sex, and age for adults in Mississippi. J Am Diet Assoc 84:788, 1984 Referenced to Koh, E.T. Comparison of dietary energy intakes and sources by race, sex, and age for adults in Mississippi. J Am Diet Assoc 84:788, 1984 Referenced to Koh, E.T. Comparison of dietary energy intakes and sources by race, sex, and age for adults in Mississippi. J Am Diet Assoc 84:788, 1984 Referenced to Koh, E.T. Comparison of dietary energy intakes and sources by race, sex, and age for adults in Mississippi. J Am Diet Assoc 84:788, 1984
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nd nd nd nd
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Estimated fructose intake: 15% of total calories estimated glucose intake 15% daily kcal Estimated fructose intake: 15% of total calories estimated glucose intake 15% daily kcal
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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: Bilirubin      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (IGTS) Glucose (IGTS) Fructose (NGTS Glucose (NGTS) Comparison Measure Fructose (IGTS) vs. Glucose (IGTS) Fructose (NGTS vs. Glucose (NGTS)


0 N/A

N Analyzed 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover)
Unit mg/dL mg/dL mg/dL mg/dL -0.9 -0.5
Baseline Value nd nd nd nd nd nd
Baseline SD nd nd nd nd nd nd
Final 5.9 6.8 6.1 6.6 nd nd
Final SD 0.3 0.3 0.6 0.4

Adverse Events
Arm or Total Title Description Comments
Fructose (IGTS) Not Reported
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Glucose (IGTS)
Fructose (NGTS
Glucose (NGTS)
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: Bilirubin      Population: All Participants Between-Arm Comparisons
Time Point Measure Fructose (IGTS) Glucose (IGTS) Fructose (NGTS Glucose (NGTS) Comparison Measure Fructose (IGTS) vs. Glucose (IGTS) Fructose (NGTS vs. Glucose (NGTS)


0 N/A

N Analyzed 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover) 9 (crossover)
Unit mg/dL mg/dL mg/dL mg/dL -0.9 -0.5
Baseline Value nd nd nd nd nd nd
Baseline SD nd nd nd nd nd nd
Final 5.9 6.8 6.1 6.6 nd nd
Final SD 0.3 0.3 0.6 0.4


Quality Dimensions
Dimension Value Notes Comments
1) Was method of randomization adequate? [Yes, No, Unsure] No
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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 Data
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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] Yes self control
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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
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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] Yes
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Quality Rating
Guideline Used Overall Rating
Medium