NNNS: Estimated and Acceptable Intake (2011)
- To assess the potential risk of randomly selected Koreans consuming processed foods containing saccharin, stevioside, d-sorbitol and aspartame, using dietary intake data from the 1998 Korea National Health and Nutrition Survey
- Concentrations of saccharin, stevioside and d-sorbitol were measured in randomly purchased processed foods from 40 food categories. Reference values for aspartame were used and foods containing aspartame were not analyzed for content in this study.
- 40 food categories containing saccharin, stevioside and d-sorbitol were selected for analysis using information from manufacturers and importers of stevioside and d-sorbitol and domestic food maufacturers. Foods containing aspartame were included, but not analyzed for content as reference values were available. Samples of all food categories were purchased randomly.
- Food consumption data obtained from the Korea National Health and Nutrition Survey, 1998. A random sample of 4,828 households were visited and all residents over the age of one were asked to complete a one-day 24-hour recall food record with assistance from family members, as needed.
- 433 households did not participate
- Children under the age of one year in participating households were excluded.
Randomly selected household residents over the age of one year, participating in the Korea National Health and Nutrition Survey in November and December 1998.
Manufacturers did not provide the amounts of artificial sweeteners in products. Testing was performed as part of the study to determine the amount of saccharin, d-sorbitol and stevioside in processed foods using HPLC analysis.
Food consumption data was part of a nationwide survey of household food consumption. It is unlikely that subjects and reviewers were aware that the data would be used to examine intakes of saccharin, stevioside, d-sorbitol and aspartame.
Calculation of EDI for the average and high consumers (90th and 95th percentiles) of saccharin, stevioside, d-sorbitol and aspartame from food consumption data
Analysis of 40 food categories for saccharin, d-sorbitol and stevioside and reference value for aspartame
Calculation of EDIs of saccharin, stevioside, d-sorbitol and aspartame were adjusted with the standard body weights of Recommended Dietary Allowances for Koreans for population and age groups
Intakes of saccharin and aspartame were compared with the Acceptable Daily Intakes (ADI) of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
Timing of Measurements
- 24-hour recall food diaries for one day, collected from study participants in November and December 1998.
- Estimated intakes of the following artifical sweeteners
- Variable One: Saccharin
- Variable Two: Stevioside
- Variable Three: D-sorbitol
- Variable Four: Aspartame.
- Consumption of artificially sweetened food products, as recorded by age of study participants.
- 4,828 households were visited.
Attrition (Final N)
- 4,395 households
- 11,525 inhabitants ages one and over.
- One- to over 65-years-old.
Other Relevant Demographics
- Those not directly interviewed due to age or infirmity were assisted by a guardian.
- None taken.
- Survey visited Korean homes nationwide.
Dependent Variable One
Dependent Variable Two
Dependent Variable Three
Dependent Variable Four
- EDIs for young children were higher than other age groups for foods containing saccharin, d-sorbitol and aspartame, due to a higher intake of artifically sweetened foods
Comparison of intakes of products containing saccharin and aspartame with the Netherlands, Denmark, Germany and the United Kingdom determined that intakes of saccharin and aspartame in Korea is less than 10% of those countries' daily intake.
- Saccharin, stevioside, d-sorbitol and saccharin are the most widely used artifical sweeteners in Korea and do not have any health impact on high consumers, (90th and 95th percentile)
- Koreans consume these artificial sweeteners daily and information on artificial sweeteners in food items is limited
- 62 items from 13 food categories were sampled for analysis of saccharin
- 62 items from nine food categories were sampled for stevioside
- 150 items from 18 food categories were sampled for d-sorbitol
- Reference values were used for food items containing aspartame
- Daily intakes recorded of average and high consumers (90th and 95th percentiles, respectively) of saccharin, stevioside, d-sorbitol and saccharin.
- EDIs for young children were higher than other age groups for foods containing saccharin, d-sorbitol and aspartame, due to a higher intake of artificially sweetened foods.
- Authors conclude that saccharin, stevioside, d-sorbitol and aspartame have no health impact on average or high consumers of these products in Korea
- EDIs were compared with ADIs set by JECFA for saccharin (five mg/kg of body weight) and aspartame (40 mg/kg of body weight)
- ADIs are not established for stevioside or d-sorbitol and the intakes of these sweeteners were not compared to the ADI.
- Comparison of the intakes of products containing saccharin and aspartame in the Netherlands, Denmark, Germany and the United Kingdom determined that intakes of saccharin and aspartame in Korea is less than 10% of those countries daily intake.
- Koreans had lower intake levels of aspartame and saccharin compared to Japanese studies, likely due to a higher use of these substances in Japanese food products.
- Current Korean consumption of artifical sweeteners is low, but gradual use of additional artificial sweeteners may increase.
- Authors recommend further research on children and infants eating artificially sweetened foods, due to their immaturity compared to adults, to measure usual intakes of artificial sweeteners for future risk assessment.
|Government:||Ministry of Health and Welfare (Korea)|
- Study adequately described the common foods in Korea, using artificial sweeteners and measured randomly purchased foods for saccharin, stevioside and d-sorbitol content. Reference values were used for foods containing aspartame.
- Intakes of saccharin, stevioside, d-sorbitol and aspartame were obtained from participants in the 1998 Korean National Health and Nutrition Survey and adequately represented these intakes in Koreans at that time
- Product analysis and study results are useful for examining the intake of artifical sweeteners in specific foods in Korea compared to the Netherlands, Denmark, Germany and the United Kingdom.
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||N/A|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||No|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||N/A|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||N/A|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||N/A|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||N/A|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||No|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||Yes|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||Yes|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||???|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||???|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||???|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||N/A|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||Yes|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||No|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||N/A|
|6.6.||Were extra or unplanned treatments described?||N/A|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||N/A|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||No|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||N/A|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||N/A|
|8.6.||Was clinical significance as well as statistical significance reported?||N/A|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||No|
|10.||Is bias due to study's funding or sponsorship unlikely?||N/A|
|10.1.||Were sources of funding and investigators' affiliations described?||???|
|10.2.||Was the study free from apparent conflict of interest?||???|