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NNNS: Adverse Effects (2011)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To outline the general toxicological observations seen during the course of the development of sucralose, a non-nutritive, high-intensity sweetener.

Inclusion Criteria:
None reported.
Exclusion Criteria:
None reported.
Description of Study Protocol:
Review.
Data Collection Summary:
Review.
Description of Actual Data Sample:
Review.
Summary of Results:

Key Findings

  • It was found that sucralose is poorly absorbed in humans, as indicated by low blood levels of sucralose, which attain a maximum within two to three hours
  • There was no accumulation of sucralose at doses 10 times the projected mean human daily human intake. After prolonged administration of sucralose, no clinical, hematological or biochemical effects were observed. A human tolerance study showed that sucralose had no effect on plasma insulin.
  • Another study showed sucralose did not stimulate the secretion of insulin and did not modify the insulinotrophic action of orally administered sucrose
  • Metabolic, biochemical, toxicological and clinical data support that sucralose is safe for use by diabetics.
Author Conclusion:

Clinical safety data are appropriate for the safety of food additives. In the case of sucralose, a careful assessment of the data has led us to the conclusion that sucralose is safe for its intended purpose of use.

Funding Source:
Industry:
McNeil Specialty Products
Food Company:
Reviewer Comments:

Descriptive summary of animal data. Human studies discussed were not referenced.

Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? Yes
 
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? No
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? No
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? No
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? No
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? No
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? No
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? No
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? No
  10. Was bias due to the review's funding or sponsorship unlikely? Yes