Advanced Search

Study Preview



Study Title and Description

Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response



Key Questions Addressed
2 What are the relationships between fructose consumption and indices of liver health?
  • Comments Comments (
    0
    ) |
4 Risk of Bias - Cohort, Case-Control, and Single Arm Studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response
Author Perez-Polo et al.
Country
Year 2010
Numbers

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
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Single Arm Trial
  • Comments Comments (
    0
    ) |
Enrollment Years nd
  • Comments Comments (
    0
    ) |
Trial or Cohort Name NCT00639756 clinicaltrials.gov
  • Comments Comments (
    0
    ) |
Funding Source Mateo Orfila Foundation
  • Comments Comments (
    0
    ) |
Inclusion Criteria Male, 40-65 y, non-smoker
  • Comments Comments (
    0
    ) |
Exclusion Criteria high BP noted by casual BP testing or the use of antihypertensive agents, the presence of diabetes, history of cardiovascular disease, gout, cancer, allopurinol allergy, psychiatric disorder, use of statins, alcoholism, illicit drug use, and a history of fructose intolerance
  • Comments Comments (
    0
    ) |
Location Spain
  • Comments Comments (
    0
    ) |
Counfounders No (Skip question #10)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Fructose Total Comments
AnswerFollow-up AnswerFollow-up
N Enrolled 83
  • Comments Comments (
    0
    ) |
N Analyzed 74
  • Comments Comments (
    0
    ) |
Mean (SD) Age, yrs 51
  • Comments Comments (
    0
    ) |
Age range (IQR) nd
  • Comments Comments (
    0
    ) |
Male % 100
  • Comments Comments (
    0
    ) |
Anthropometry data BMI 28.5
  • Comments Comments (
    0
    ) |
Alcohol Intake Avoid alcohol
  • Comments Comments (
    0
    ) |
Co-morbidity (other diseases/conditions) No
  • Comments Comments (
    0
    ) |
Other important baseline characteristics or baseline confounders Age, dietary intake
  • Comments Comments (
    0
    ) |
Background Diet Baseline dietary intake
  • Comments Comments (
    0
    ) |
FFQ
  • Comments Comments (
    0
    ) |
Referenced to Martin-Moreno et al. Int J Epidemiol 1993; 22:512-519
  • Comments Comments (
    0
    ) |
no
  • Comments Comments (
    0
    ) |
Total energy=2400-2600 with mean carbohydrate intake of 52%, protein 17%, and fat 31%. Dietary intake of fructose was about 55 g/d (of which 24 g was derived from sucrose)
  • Comments Comments (
    0
    ) |
Race/Ethnicity nd
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: AST      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 20
Baseline Standard Error 0.6
Delta +3
Delta Standard Error 1
Net Difference nd
Net Difference CI nd
P between <0.07
Outcome: ALT      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 30
Baseline Standard Error 3.4
Delta +9
Delta Standard Error 5
Net Difference nd
Net Difference CI nd
P between ns
Outcome: GGT      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 36
Baseline Standard Error 3
Delta +13
Delta Standard Error 4
Net Difference nd
Net Difference CI nd
P between ns
Comments

Adverse Events
Arm or Total Title Description Comments
Fructose Intervention 9 of 83 drop off (diarrhea or abdominal cramps), 22 of 74 (diarrhea, abdominal cramps, or flatulence), 3 of 74 (pruritus)
  • Comments Comments (
    0
    ) |
Total

Extraction Form: Cohort, Case Control, Single Arm Quality


Results & Comparisons


Results Data
Outcome: AST      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 20
Baseline Standard Error 0.6
Delta +3
Delta Standard Error 1
Net Difference nd
Net Difference CI nd
P between <0.07
Outcome: ALT      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 30
Baseline Standard Error 3.4
Delta +9
Delta Standard Error 5
Net Difference nd
Net Difference CI nd
P between ns
Outcome: GGT      Population: All Participants
Time Point Measure Fructose


0 N/A

N Analyzed 36
Unit UI-1
Baseline Value 36
Baseline Standard Error 3
Delta +13
Delta Standard Error 4
Net Difference nd
Net Difference CI nd
P between ns
Comments


Quality Dimensions
Dimension Value Notes Comments
1) Representativeness of the exposed cohort. Yes
  • Comments Comments (
    0
    ) |
2) Ascertainment of nutrient exposure No
  • Comments Comments (
    0
    ) |
3) Demonstration that outcome of interest was not present at start of the study No
  • Comments Comments (
    0
    ) |
4) Description of a validated method to quantify the amount, per type, of nutrient of interest No
  • Comments Comments (
    0
    ) |
5) Assessment of outcome No
  • Comments Comments (
    0
    ) |
6) Was follow up long enough for outcomes to occur? 11%
  • Comments Comments (
    0
    ) |
7) Adequacy of follow up of cohort No
  • Comments Comments (
    0
    ) |
8) Analytic control for confounding (ANY confounders other than age and sex) Unsure
  • Comments Comments (
    0
    ) |
9) Analytic control for confounding: anthropomentrics No
  • Comments Comments (
    0
    ) |
10) Analytic control for confounding: other nutrients Yes
  • Comments Comments (
    0
    ) |
11) Power calculation to support sample size Yes
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating
Medium