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NNNS: Diabetes and Glycemic Response (2011)

Citation:
 
Study Design:
Class:
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Quality Rating:
Research Purpose:

This study examined consumption of intense sweeteners by a group of French insulin-dependent children in 1997, estimated the Theoretical Maximum Daily Intake (TMDI) for the three most commonly consumed sweeteners and compared them with the relevant average daily intake (ADI) values.

Inclusion Criteria:
  • Diabetic members of the Aide aux Jeunes Dia­betiques' (AJD; Aid for Young Diabetics) Association
  • Age: Two to 20 years.
Exclusion Criteria:

None stated.

Description of Study Protocol:

Background

  • At the time of this study, five intense sweeteners, Acesulfame K (E950), aspar­tame (E951), cyclamic acid (E952), saccharin (E954) and neohesperidine (E959), were authorized in Europe as food additives and table-top sweeteners. They were assigned acceptable daily intake (ADI) values of, 0±9mg, 0±40mg, 0±11mg, 0±5mg and 0±5mg per kg of body weight, respectively, by the European Scientific Committee on Food (SCF).
  • A European Commission analysis of food additive intake in the general population had shown that three of the five authorized intense sweeteners (aspartame, saccharin and acesulfame K) were used at particularly high levels in sugar-free foods and were also commonly used as table-top sweeteners.

Recruitment

During routine distribution of a regular newsletter to its 6,700 members, the Aide aux Jeunes Dia­betiques' (AJD; Aid for Young Diabetics) Association included a questionnaire to 400 randomly-selected diabetic members. These individuals were asked to complete the food intake survey and return it by mail.

Design

  • Food consumption by young diabetics was deter­mined using a prospective five-day diary record, which was completed by the teenagers themselves, while parents were asked to help younger children with completion
  • Special instructions were given to ensure that data concerning sweeteners and sugar-free products were entered as precisely as possi­ble
  • Subjects were then classified as consumers or non-consumers of sweeteners over the five-day period.

Blinding

Blinding was not addressed.

Statistical Analysis

  • A general description of the analysis methods are described in the dependent variable section below
  • The paper did not describe the specific analytical methods.
Data Collection Summary:

Timing of Measurements

Five-day food diary.

Dependent Variables

  • Estimated Theoretical Maximum Daily Intake (TMDI) of aspartame, sac­charin and acesulfame K
  • A sweet­ener concentration database was developed in order to calculate the intake of aspartame, sac­charin and acesulfame K
  • The French food composition database (Favier et al, 1995) was supplemented by specific information on swee­tened food and beverages and the table-top sweeteners used by diabetics
  • The concentrations present in table-­top sweeteners (real concentrations) were those defined on the label for each product
  • The concentrations present in sugar-free products (maximum concentrations) were those listed by the European Directive (94/35/CE)
  • The categories of products, which could be sugar-free, inclu­ded non-alcoholic beverages, desserts, confectionery, chewing gum, fruits and fruit preparations and sauces.

Independent Variables

  • Body weight: Kilograms
  • Age: Participants were sorted into five age groupings for analysis
  • Gender
  • Mean calorie intake: This was determined from the five-day food record and French food composition database.
  • To provide a conservative assessment of exposure, all sugar-free products were assumed to be sweetened with the same intense sweetener at the maximum authorized con­centration
  • The consumption data collected from subjects were combined with sweetener concentration data to produce an estimate of the maximum intake in each subject and for each sweetener
  • The TMDI, in mg per kg body weight, was then calculated by dividing the total intake for each subject by his or her declared body weight. The result was compared against the ADI value.
Description of Actual Data Sample:
  • Initial N: 400 diabetic children
  • Attrition (final N): 227 diabetic children (112 girls, 115 boys)
  • Ethnicity: French citizens
  • Age: Two to 20 years old
  • Other relevant demographics: None addressed
  • Anthropometrics: Height and weight were self-reported. The mean height was 1.48±0.16m and the mean weight was 42.5±14kg.
  • Location: France. There were study participants from all 65 French administrative departments (equivalent to US states).
Summary of Results:
  • The mean calorie intake was 1,931kcal per day (1,853kcal in girls and 2,007kcal in boys). The mean protein, lipid and carbohydrate intakes were 82g, 80g and 219g per day, respectively, which corresponds to 17%, 37% and 46% of the total calorie intake. These results are similar to those obtained for the gen­eral population of the same age in France.
  • 84% of the study popula­tion had con­sumed at least one sugar-free product or table-top sweetener during the five-day period of the survey
  • Based on the estimated mean and 97.5th percentile of the distribution of consumption, the study found it unlikely that total exposure of aspartame, saccharin and acesulfame-K would rise above the approved Average Daily Intake (ADI) levels. See Table One below.

Table One: Distribution of the TMDI of Intense Sweeteners in all Subjects and in Consumers of Sugar-Free Products Only

  Mean Median 97.5th Percentile Maximum
Aspartame (ADI=40mg/kg bwa) All subjects (N=227) Mg/person/day
69.4
44
255.8
392.6
Mg/kg BW/day
1.9
1.1
7.8
15.6
Consumers only (N=192) Mg/person/day
82.0
55.5
263.8
392.6
Mg/kg BW/day
2.4
1.4
7.8
15.6
Saccharin (ADI=five mg/kg bw) All subjects (N=227) Mg/person/day
9.9
6.0
39.1
60.8
Mg/kg BW/day
0.3
0.1
1.1
2.7
Consumers only (N=174) Mg/person/day
12.9
8.0
44.3
60.8
Mg/kg BW/day
0.4
0.2
1.3
2.7
Acesulfame K (ADI=nine mg/kg bw) All subjects (N=227) Mg/person/day
29.8
16.5
129.3
212.8
Mg/kg BW/day
0.8
0.4
3.7
8.7
Consumers only (N=174) Mg/person/day
38.9
26.2
136.2
212.8
Mg/kg BW/day
1.1
0.7
4.0
8.7

Aspartame

  • The average TMDI for aspartame, calculated in the total population, represented less than 5% of the ADI, while maximum values reached about 40% of the ADI. Very few differences were observed between girls and boys and results expressed in terms of kg of body weight were similar.
  • Aspartame intake did not exceed the ADI in any subject
  • Even high-level intakes measured at the 97.5th percentile and the max­imum intake remained within acceptable limits
  • Non-alcoholic diet beverages and table-top sweeteners made the greatest contribution to the TMDI for aspartame (56 and 16%, respectively).

Saccharin

  • More than 76% of the popula­tion was found to consume sugar-free products or table­top sweeteners, which could contain saccharin
  • The average calculated saccharin intake was 0.4mg per day per kg body weight. The max­imum level of intake recorded was 2.7mg of saccharin per day per kg body weight, corresponding to 54% of the ADI.
  • Between the ages of seven and 17 years, average intakes increased with age in both boys and girls, but were very stable as a function of body weight. However, the sac­charin intake in younger subjects (2±6 years) was found to be higher than seen in other age groups (25% of the ADI).
  • The results concerning saccharin show that both high intake levels estimated at the 97.5th percentile of the distribution curve remained within acceptable limits
  • The principal source of saccharin was non-alcoholic diet beverages (65% of total intake).

 Acesulfame K

  • The average calculated acesulfame-K intake was 1.1mg per day per kg of body weight, while the maximum level of intake recorded was 8.7mg per day per kg of body weight. These results corresponded to 11% and 96% of the ADI, respectively.
  • No significant differences were found between girls and boys. Although intake increased between the ages of seven years and 17 years, it remained very stable as a function of body weight. The intake among young chil­dren aged 2±6 years was higher than among those aged 7±10 years and this difference was more marked when expressed on a mg-per-kg basis.
  • The intake of acesulfame did not exceed the ADI in any subject. High-level intakes measured at the 97.5th percentile of the distribution curve remained within acceptable limits, even though the maximum level was close to the ADI.
  • The principal source of acesulfame-K was non-alcoholic diet beverages (75% of total intake).
Author Conclusion:
  • This study confirmed that diabetics consume a large quantity of sugar-free products and that diabetic children are among the highest consumers of sweeteners in France, with median intakes (in mg per kg) exceeding the 90th per­centile of the general French population
  • In terms of the three intense sweeteners selected for this study (aspartame, saccharin and acesulfame K), the authors did not observe any intake in excess of the ADI, despite conservative assumptions in their methodology. The authors state that this finding is consistent with those obtained at an interna­tional level, despite differences in the methodologies employed.
Funding Source:
Government: INRA-DSNHSA, French Ministry for Finance, DGCCRF
Reviewer Comments:
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) N/A
  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? 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? Yes
  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)? 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? No
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