EAL

NNNS: Estimated and Acceptable Intake (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Quantitative assessment of the intake of intense sweeteners over a 12-day period in:

A random sample of teenagers, ages 14 to 17, living in the District of Rome, Italy
A sample of females, ages 14 to 17, with a high consumption of sugar-free soft drinks
A sample of females, ages 14 to 17, with a high consumption or table-top sweeteners.

Intense sweeteners:

Saccharin
Apartame
Acesulfame K
Cyclamate
Neohesperidin DC
Thaumatin.

Estimate intake of the above sweeteners if all foods consumed were substituted with sugar-free versions (worst-case scenario).

Inclusion Criteria:

All students from the participating schools were asked to fill in a questionnaire related to food intake in the previous year, duration of dieting periods (if applicable) and to the frequency of table-top sweetener and sugar-free soft drink intake.

Males and females completing the food frequency questionnaire were randomly selected
Females who consumed table-top sugar-free sweeteners at least once every two days
Females who consumed at least 1.5 glasses of sugar-free soft drinks daily.

Exclusion Criteria:

Students were excluded if they did not report food consumption in sufficient detail or repeatedly omitted between-meal eating
10 schools were selected at random, one did not participate in the study.

Description of Study Protocol:

Recruitment

Male and female secondary school students

Ages 14 to 17
From nine public secondary schools in the District of Rome, Italy, selected at random from 256 schools in Rome (163) and other towns within the district (93)
Completion of a food frequency questionnaire on the previous year, including possible dieting periods and intake of table-top sweeteners and sugar-free soft drink.

Design

Cross-sectional.

Blinding Used

The specific purpose of the study was not disclosed to students, teachers and parents of students. They were told that the aim of the research was to examine eating patterns of teenagers.

Statistical Analysis

Data entry for food diaries using ad hoc software (INRAN 2003)

Quantity and unit of measurement in grams, glasses, spoons and a food code was selected from food and recipe databanks
Manual check of food diaries with unusual amounts (high or low calorie intake).

Food intake data were analyzed to assess the intake of itense sweeteners and compared to Acceptable Daily Intakes (ADI), as established by the Scientific Committee for Food, European Commission, per mg per kg of body weight for each participant.

Saccharin: Five mg/kg
Acesulfame K: Nine mg/kg
Cyclamate: Seven mg/kg
Aspartame: 40mg/kg.

[Note: Thaumatin and neohesperidin DC were not present in any of the sugar-free products consumed.]

Worst-case scenario for the intake of intense sweeteners: Assuming a hypothetical future substitution of all regular food products with sugar-free version in six categories (intakes expressed in units, one teasoon of sugar = one unit of sweetener)

Added sweeteners
Candies
Chewing gum
Mousse and yogurt
Jams
Fizzy drinks, fruit juices and iced teas.

Data collection included a specific code for each single version of a product for each brand.

Food labels were collected
Producers provided average concentration of intense sweetener of each single sugar-free product consumed during the survey.

Height and weights were measured through Zerfas Method

Body mass index (BMI): Weight/height²
BMI cut-off points, per International Obesity Task Force, to identify normal, overwieight and obese subjects
BMI cut-off points of NCHS to identify underweight subjects
Subjects were asked to report on physical activity and dieting over the study period.

Data Collection Summary:

Timing of Measurements

12 days during the school year, three- to four-day food consumption diaries were collected.

Dependent Variables

Variable One: Intake of intense sweeteners in random sample of males and females
Variable Two: Intake of intense sweeteners in females consuming table-top sugar-free sweeteners every two days
Variable Three: Intake of intense sweeteners in females consuming 1.5 sugar-free beverages daily
Variable Four: "Worst-case scenario," assuming that sugar-free versions of all foods were consumed.

Independent Variables

Food consumption of foods containing sugar-free or intense sweeteners.

Control Variables

None.

Description of Actual Data Sample:

Initial N

362 male and female teenagers
Ages 14 to 17.

Attrition (Final N)

Group One: 125 males, 108 females, including 10 females identified as high consumers of sugar-free soft drinks and tabletop sugar-free sweeteners
Group Two: 79 females with high consumption of table-top sweeteners
Group Three: 75 females with high consumption of sugar-free soft drinks.

Ages

14 to 17 years old.

Ethnicity

Not identified
All teenagers lived in the District of Rome.

Other Relevant Demographics

Participants self reported age, sex, rural or urban residence and education level of parents
Participants included teenagers from rural and urban areas and teenagers of varied socio-economic status
There were more males in the screening sample, as the larger schools had more males, consistent with recent census data: In 1997-1998, males accounted for 51% of the age group of teenagers, 15 to 19 years old.

Anthropometrics

Participants self reported height, weight and dieting history prior to and during the study period
During the study, height, weight and Body Mass Index were measured through Zerfas method, using standardized scales and portable stadiometers
BMI for over- and underweight, determined by the International Obesity Task Force and NCHS, respectively.

Location

District of Rome, Italy.

Summary of Results:

Sugar-Free Sweetener Consumed


	Aspartame (mg/kg BW) ADI=40	Acesulfame K (mg/kg BW) ADI=9	Saccharin (mg/kg BW) ADI=5	Cyclamate (mg/kg BW) ADI=7
Variable One: Random males and females	0.039, max 0.445	0.011, max 0.444	0.00, max 0.071	0.014, max 1.24
Variable Two: Females with high intakes of sugar-free soft drinks	0.091, max 0.875	0.043, max 0.60	0.001, max 0.062	0.086, max 1.63
Variable Three: Females with high intakes of sugar-free table-top sweeteners	0.172, max 1.3	0.041, max 0.45	0.03, max 0.23	0.05, max 1.2

Worst-Case Scenario Intake

	Aspartame (mg/kg BW) ADI 40	Acesulfame K (mg/kg BW) ADI 9	Saccharin (mg/kg BW) ADI 5	Cyclamate (mg/kg BW) ADI 7
Random males and females	8.7	4.5	2.7	4.3
Females with high intakes of sugar-free soft drinks	13.6	6.9	2.7	6.9
Females with high intakes of sugar-free table-top sweeteners	7.8	4.3	2.2	4.4

Other Findings

Females on diets consumed more sugar-free products during the study
As noted previously, the study did not include the summer months when more soft drinks may be consumed
Medicines and supplements were not found to be contributing factors to artificial sweetener intake.

Author Conclusion:

The study sample represented adolescents living in the District of Rome, Italy, during the school year, 2000-2001
Consumption data did not include the summer months and consumption of sugar-free soft drinks may have been underestimated
A 91.8% completion rate was attributed to motivating students to complete the study with a detailed dietary analysis and specific nutritional advice
Female teenagers on diets consumed more sugar-free products during the study
106 brands of sugar-free products were consumed during the study: Beverages, table-top artificial sweeteners, candies, chewing gums, yogurts, jam and mousse.
No intakes in excess of Acceptabe Daily Intake (ADI) were found in: Saccharin, aspartame, acesulfame K or cyclamate
Risk of intakes exceeding ADI for intense sugar-free sweeteners in Italian teenagers is low, even under the "worst-case scenario" with all foods substituted with sugar-free versions.
Authors note that with the introduction of new artificial sweeteners and increased use in food products, further studies are needed on consumption and exposure to sugar-free sweeteners.

*Authors note that the Commission of European Communities has recently proposed to ban cyclamates in certain food categories and reduce concentration allowed in soft drinks.

Funding Source:

Government:

National Institute for Food and Nutrition (Italy)

Reviewer Comments:

Study was representative of consumtion of sugar-free or intense sweeteners by Italian teenagers, ages 14 to 17, over 12 days, in the school year of 2000-2001
Intakes of saccharin, aspartame, acesulfame K and cyclamates did not exceed the Acceptable Daily Intakes (ADI) derived from food consumption data
Study examined the intakes of the above sweeteners in three groups:

Males and females, ages 14 to 17
Females consuming sugar-free sweeteners once every two days
Females consuming 1.5 servings of sugar-free soda daily.

Under the "worst-case scenario" (subsitution of all foods consumed with sugar-free versions), intakes of the above sugar-free or intense sweeteners did not exceed the ADIs for these products.

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)	N/A
	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

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?	Yes
	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.)	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?		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?	No
	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?		N/A
	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?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	N/A
	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?	N/A
	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?	N/A
	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?		N/A
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	N/A
	8.2.	Were correct statistical tests used and assumptions of test not violated?	N/A
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	N/A
	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?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	???
	10.2.	Was the study free from apparent conflict of interest?	Yes