NNNS: Estimated and Acceptable Intake (2011)
Ilback NG, Alzin M, Jahrl S, Enghardt-Barbieri H, Busk L. Estimated intake of the artificial sweeteners acesulfame-K, aspartame, cyclamate and saccharin in a group of Swedish diabetics. Food Additives and Contaminates, 2003 Feb; 20 (2): 99-114.PubMed ID: 12623659
- To estimate the intake of the artificial sweeteners acesulfame-K, aspartame, cyclamate and saccharin by children (zero to 15 years of age) and adult male and female diabetics (types 1 and 2) of various ages (16 to 90 years) in Sweden
- Intakes were also compared to the Average Daily Intakes (ADI) set by the Joint FAO/WHO Expert Committee on Food Additives.
- Members of the Association of Diabetics in the Stockholm area of Sweden
- The study population included women, men and children.
- 1,120 diabetics were asked to complete a food frequency questionnaire about their sweetened food intake
- The response rate (71%, range of 59% to 78%) was comparable across age and gender groups.
Timing of Measurements
- Food frequency questionnaire was mailed with cover letter
- The questionnaire was formulated to extract information about participants' gender, age, height, weight, type of diabetes (1 or 2), how long had they been a diabetic and how long they had received treatment for diabetes
- The questionnaire also asked about the size and frequency of sweetened food intake.
- Average daily intake (ADI) of artificial sweeteners including acesulfame-K, aspartame, cyclamate and saccharin
- Intake of each sweetener was calculated using the average daily volume of each individual's consumption of the relative food items, divided by the participant's body weight
- This calculation was also made at the 10% and 5% levels among individual consumers in each group, in order to obtain the average consumption among high users for each category
- The individual food category averages were then multiplied by the maximum amount of sweetener that is allowed to be added to each specific item to determine the maximum exposure.
- Frequency of reading product content information.
- Medical treatment
- Consumption pattern of artificially sweetened foods: Cider and sugar syrup.
- Initial N: 1,120 participants were asked to complete a questionnaire about their sweetener intake. The response rate (71%, range 59-78%) was comparable across age and gender groups
- Attrition (final N): 790 individuals responded to the questionnaire; 311 women, 235 men and 243 children
- Age: Children one to 15 years of age, adults 16 to 90 years old
- Ethnicity: Race was not mentioned, however participants were Swedish citizens.
- Other relevant demographics: Weight, height, medical treatment. No differences noted among groups.
- Anthropometrics: Weight
- Location: Stockholm, Sweden.
Average Daily Consumption of Sweeteners
- The food items that contributed most to the total intake of sweeteners were diet soda, cider, fruit syrup and table-top sweetener. Fruit syrup was the most important single source of intake.
- Table-top powder was high in children and was the most important single source of cyclamate for this age group
- The average intake for high-consumers among adult men and women (5% and 10% level) was, in almost all cases, below the ADI and often far below it
- The calculated intake of sweeteners in fruit syrup for children (5% level) was close to or exceeded the ADI for acesulfame-K (146% of ADI), aspartame (94%), cyclamate (227%) and saccharin (100%)
- With the exception of yogurt, no food item contributed more than 10% relative to the intake from fruit syrup.
Intake of Sweeteners From Beverages
- Acesulfame-K: Children at the 10% and 20% levels consumed 169% and 124% of the ADI, respectively
- Aspartame: Children at the 10% and 20% levels consumed 109% and 80% of the ADI, respectively
- Cyclamate: Children at the 10% and 20% levels consumed 263% and 193% of the ADI, respectively. In women, the corresponding value at the 10% individual level was close to the ADI at 101%.
- Saccharin: The only value that exceeded the ADI was at the 10% individual level in children, where the intake was 116% of the ADI.
Total Intakes of Beverages and Table Powder Combined
- Acesulfame-K: Not used in Sweden as a table-top powder
- Aspartame: Children at the 10% level exceeded the ADI at 114%
- Cyclamate: Children at the 10% and 20% levels consumed 317% and 231% of the ADI, respectively. Women exceeded the ADI at the 10% level (110% of ADI), whereas the intake at the 20% level was at 77%.
- Saccharin: Children at the 10% level were estimated to exceed the ADI at 126%.
- The eight most consumed foodstuffs were diet soda, cider, fruit syrup, table powder, table tablets, table drops, ice cream, chewing gum, throat lozenges, sweets, yogurt and vitamin C
- The major sources of sweetener intake were beverages and table powder
- About 70% of the participants, equally distributed across all age groups, read the manufacturer's specifications of the food products' content
- The estimated intakes showed that neither men nor women exceeded the Average Daily Intake (ADI) for acesulfame-K. However, using worst-case calculations, high intakes were found in young children (169% of ADI).
- In general, the aspartame intake was low
- Children had the highest estimated (worst-case) intake of cyclamate (317% of ADI)
- Children's estimated intake of saccharin only slightly exceeded the ADI at the 5% level for fruit syrup
- Children had an unexpectedly high intake of table-top sweeteners, which in Sweden, is normally based on cyclamate.
|Government:||National Food Administration (Sweden)|
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)||Yes|
|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?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||???|
|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?||Yes|
|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.)||N/A|
|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?||N/A|
|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?||N/A|
|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?||Yes|
|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.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||Yes|
|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?||Yes|
|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?||Yes|
|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?||N/A|
|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?||Yes|
|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)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|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?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|