EAL

NNNS: Estimated and Acceptable Intake (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

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.

Inclusion Criteria:

Members of the Association of Diabetics in the Stockholm area of Sweden
The study population included women, men and children.

Exclusion Criteria:

None stated.

Description of Study Protocol:

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.

Data Collection Summary:

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.

Dependent Variables

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.

Independent Variables

Weight
Height
Medical treatment
Consumption pattern of artificially sweetened foods: Cider and sugar syrup.

Description of Actual Data Sample:

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.

Summary of Results:

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%.

Author Conclusion:

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.

Funding Source:

Government:	National Food Administration (Sweden)
University/Hospital:	Uppsala University

Reviewer Comments:

It was not possible to recreate all of the bar charts that were presented in this paper.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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

Validity Questions
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