EAL

NNNS: Estimated and Acceptable Intakes (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate the dietary intake of aspartame, cyclamate and saccharin in Germany (FRG) in 1988 and 1989.

Inclusion Criteria:

Phase I: Individuals with complete 24-hour records of the amount and type of all foods and drinks consumed
Phase II: Individuals consuming amounts within the top quartile (25%) of the ADI. In terms of the study, this was defined as high consumption.

Exclusion Criteria:

Other than that stated above.

Description of Study Protocol:

Design

The study was conducted in two phases:

The first phase evaluated one-day (24-hour) food records to assess sweetener intake in a representative sample of the population. The total daily intake was calculated for each person from the sweetener content of each product and was expressed in mg per kg of body weight (bw). 35.9% of the participants ingested one or more sweeteners on the examination day.
In the second phase, sweetener intake was further evaluated during a seven-day period in those subjects who in the one-day study ingested any of the sweeteners in excess of 75% of the ADI.

Data Collection Summary:

Dependent variables: Aspartame, cyclamate, saccharin intakes
Independent variables: Food and beverage consumption reported in food diaries.

Description of Actual Data Sample:

Initial N

An explanatory letter and one-day food diary form was mailed to 2,800 individuals selected to represent the German population in terms of sex, age and geographical location.

Final N

Phase I: 2,291 individuals returned complete questionnaires and one-day food diaries.
Phase II: 882 participants reported an intake of sweeteners in the one-day food diaries. Of those, 38 individuals exceeded 75% of the ADI for cyclamate, and three exceeded the 75th percentile for saccharin. One participant with high cyclamate intake was not available to participate in Phase II of the study.

Summary of Results:

822 participants (35.9%) ingested one or more sweeteners on the one-day examination
A high sweetener intake on the one-day food record was a poor predictor of a high seven-day average daily intake. If the one-day record had been used to classify individuals to the high-use category, 80% of the users would have been misclassified to the top fifth percentile of cyclamate consumption (38 of 822 subjects = 4.6%).
For users of intense sweeteners, the mean intakes of aspartame, cyclamate and saccharin were 0.15, 2.62 (ADI=11mg per kg of body weight) and 0.250mg per kg of body weight per day (ADI=2.5mg per kg of body weight), respectively
At the 90th percentile of intake, i.e., for the heavy consumer, the ingestion of cyclamate and saccharin was about 2.5 times higher
Due to its limited use in foods and beverages at the time of the study, only 12% of the sweetener users ingested aspartame
Persons who adhered to a diet (diabetes, weight control) did not ingest sweeteners in substantially higher amounts
Tabletop sweeteners and beverages were the most important sources of sweetener and they contributed more than 80% of the total intake
Consumption of sweeteners in excess of the Acceptable Daily Intake (ADI) was rarely observed (saccharin N=1, cyclamate N=16).

Author Conclusion:

The results indicate that at the time of the study the (then valid) German sweetener regulation protected the consumer adequately and that the sweetener intake was within recommended limits in 99.8% of all examined persons. See the reviewer's note below, regarding the sweeteners examined in this study.

Funding Source:

Industry:

International Sweetners Association

Commodity Group:

Reviewer Comments:

Cyclamate and saccharin were the prominent sweeteners in this study because aspartame was at that time permitted only under special regulatory exemption and products containing acesulfame-K were not yet available
The Non-Nutritive Sweeteners Expert Working Group limited its conclusions to sweeteners that are currently available in the United States. Cyclamates are not sold in the US. Therefore, although this article and associated worksheet include data about cyclamates, it will not be included in the Working Group's evidence-based conclusions.

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?	Yes
	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?	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?	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?	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?		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.)	N/A
	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?	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?	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)?	N/A
	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