Nutritive and Non-Nutritive Sweeteners

NNNS: Estimated and Acceptable Intake (2011)

Citation:
Toledo MC, Ioshi SH. Potential intake of intense sweeteners in Brazil. Food Addit Contam. 1995 Nov-Dec; 12 (6): 799-808. PubMed ID: 8608854
 
Study Design:
Cross-sectional
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To examine consumption levels of the intense sweeteners aspartame, cyclamate and saccharin in Brazil.
Inclusion Criteria:
Intense sweetener consumers.
Exclusion Criteria:
Individuals who did not consume sweeteners: This was not specifically stated, but can be inferred by reading the article.
Description of Study Protocol:

Recruitment

  • The respondents were randomly chosen among intense sweetener consumers living the cities of Campinas, Sao Paulo and Curitiba, Parana
  • Face-to-face interviews were conducted in public places normally visited by sweetener consumers, such as diabetic associations, hospitals, sweetener shops and gyms.

Design

  • Data on the potential intake of the intense sweeteners aspartame, cyclamate and saccharin were generated, based on a representative sample of 673 individuals who completed a food frequency questionnaire designed to collect information on demographic details and habitual usage of sweetener-containing food and drinks
  • Potential daily intakes by individuals were calculated for each sweetener by combining each person's consumption of sweetener-containing food and beverages with information generated by the determination of the concentrations of the sweeteners used in these products.

Blinding Used

  • Not mentioned.

Statistical Analysis

  • SAS and Statigraphics programs were used. Differences analyzed with paired T-test at 5% significance.
  • All soft drinks and table-top sweeteners recorded in the questionnaire were chemically analyzed to determine the actual concentration of the added sweeteners. Aspartame and saccharin were determined using HPLC with a UV detector. Cyclamate was determined by UV/VIS spectrophotometry. For food products with relatively low levels of consumption, mean sweetener concentrations were obtained from package labels.
Data Collection Summary:

Timing of Measurements:

  • The food frequency surveys were completed in the winter of 1990 and summer of 1991
  • The frequency of consumption of all types of food and drink likely to contain sweeteners as well as of table-top sweeteners was recorded on a daily, weekly or monthly basis, depending on the dietary habit of the respondent. The quantity was recorded in units (g or ml) or in household measures.
  • Portion size models specifically designed for the survey were used to assist in determining the amount of each product consumed by individuals. 

 Dependent Variables

  • Aspartame, cyclamate and saccharin were calculated from the sweetener content of foods, soft drinks and table-top products. The amounts were expressed as mg per kg of body weight.

Independent Variables

  • Height and weight: Methods not described; these may have been self-reported.
Description of Actual Data Sample:
  • Initial N: It appears that individuals were identified and surveyed at the same time, so the initial and final Ns are the same
  • Attrition (final N): 673 participants; 339 from Campinas (73% female) and 334 from Curitiba (75% female). Women were over-represented, reflecting the role of gender in sweetener intake.
  • Age: Ranged from one to 89 years, 74% fell between 20 and 60 years
  • Ethnicity: Brazilian
  • Other relevant demographics: 30% of participants had attended university, while 25% had, at most, a first grade education
  • Anthropometrics: 77% of the participants' weights ranged from 50kg to 80kg. There were no statistically significant differences noted between the groups.
  • Location: The cities of Campinas, Sao Paulo and Curitiba, Parana in Brazil. Campinas has a warm climate, while as Curitiba's climate is cooler.
Summary of Results:
  • The data showed that 72% of the studied population consumed saccharin, 67% cyclamate and 40% aspartame. At the time of the study, most of the diet soft drinks and table-top sweeteners were saccharin and cyclamate.
  • The main reasons stated for the use of intense sweeteners were weight-control diet (36%), diabetes (35%) and weight loss (23%)
  • Table-top sweeteners were the major source of sweeteners, followed by soft drinks
  • The median daily intake of aspartame, cyclamate and saccharin represented approximately 2.9%, 15.5%, and 16% of the corresponding ADI, respectively. 

Potential Median Daily Intake of Intense Sweeteners (mg per kg of Body Weight)

Sweetener

ADI*
(mg/kg bw)

Total

Diabetics

Weight-control

Aspartame

0-40

1.17

1.02

1.28

Cyclamate

0-11

1.70

1.98

1.45

Saccharin

0-05

0.82

0.94

0.75

*Acceptable Daily Intake, as recommended by FAO/WHO Joint Expert Committee of Food Additives

  • Diabetics, in general, had a much higher intake within the studied population
  • The consumption data did not reveal differences between the seasons.
Author Conclusion:
  • Results indicate that daily intakes of aspartame, cyclamate and saccharin are within their respective Acceptable Daily Intake levels
  • The intense sweetener consumption data collected did not reveal differences between the seasons. This suggests that the data recorded in the survey may be considered representative of normal eating habits over the course of the year.
Funding Source:
Government: Laboratório Central do Paraná (Brazil)
University/Hospital: Universidade Estadual de Campinas (Brazil)
Reviewer Comments:
  • 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.
  • The survey methods are not described in detail. It appears that the food frequency questionnaire was administered on-site at the time of recruitment.
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? No
  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? ???
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) ???
  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? No
  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%.) ???
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  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? No
  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.) No
  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? 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? 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)? 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