EAL

NNNS: Adverse Effects (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To review the safety of sucralose and sucralose-mixture products such as granulated Splenda.

Inclusion Criteria:

Not applicable.

Exclusion Criteria:

Not applicable.

Description of Study Protocol:

Design

Narrative review of sucralose safety studies.

Data Collection Summary:

Not applicable.

Description of Actual Data Sample:

Not applicable.

Summary of Results:

Key Findings

Oral intake of sucralose is mostly unabsorbed, is excreted unchanged and is not metabolized as an energy source. It is not broken down into smaller chlorinated compounds, does not form any known haptens and is not bioaccumulated; so sucralose appears to be inert in the body
No adverse effects of sucralose have been noted at extremely high doses in animal studies
No adverse effects of sucralose consumption have been noted in pregnant or lactating animal studies, and no increased incidence of birth defects has been noted in animal studies
No increased carcinogenicity has been noted in animal studies
In human tolerance studies, no adverse effects on hematology, cardiovascular parameters, urinalysis or blood chemistry were noted
There is some evidence that sucralose used to replace sugar calories in an overall healthful lifestyle program may be helpful in weight management in overweight children (Rodearmel, 2007).

Author Conclusion:

Sucralose no-calorie sweetener has an extensive database supporting its safety in both animal and human subjects. There are no limits for the use of sucralose with any population sub-type, including children and people with diabetes. No evidence exists that sucralose interferes with any type of health treatment regimen. Sucralose appears to have no effect on weight, although it may be used in weight management programs to reduce overall calorie intake by replacing nutritive sweeteners. Sucralose is a safe sweetener that may be used over the course of a lifetime.

Funding Source:

Industry:

Mcneil Nutritionals

Pharmaceutical/Dietary Supplement Company:

Reviewer Comments:

No systematic method for including and excluding research studies was described.

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?	No

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?	Yes
	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?	Yes
	9.	Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed?	???
	10.	Was bias due to the review's funding or sponsorship unlikely?	???