Expert Panel report on a study of Splenda in male rats

A recent study in rats investigated the retail sweetener product, Granulated SPLENDA ® No Calorie Sweetener (Splenda) (Abou-Donia et al., 2008. Splenda alters gut microflora and increases intestinal P-glycoprotein and cytochrome P-450 in male rats. J. Toxicol. Environ. Health A, 71, 1415–1429), whic...

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Veröffentlicht in:Regulatory toxicology and pharmacology 2009-10, Vol.55 (1), p.6-12
Hauptverfasser: Brusick, David, Borzelleca, Joseph F., Gallo, Michael, Williams, Gary, Kille, John, Wallace Hayes, A., Xavier Pi-Sunyer, F., Williams, Christine, Burks, Wesley
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container_end_page 12
container_issue 1
container_start_page 6
container_title Regulatory toxicology and pharmacology
container_volume 55
creator Brusick, David
Borzelleca, Joseph F.
Gallo, Michael
Williams, Gary
Kille, John
Wallace Hayes, A.
Xavier Pi-Sunyer, F.
Williams, Christine
Burks, Wesley
description A recent study in rats investigated the retail sweetener product, Granulated SPLENDA ® No Calorie Sweetener (Splenda) (Abou-Donia et al., 2008. Splenda alters gut microflora and increases intestinal P-glycoprotein and cytochrome P-450 in male rats. J. Toxicol. Environ. Health A, 71, 1415–1429), which is composed of (by dry weight) maltodextrin (∼99%) and sucralose (∼1%). The investigators reported that Splenda increased body weight, decreased beneficial intestinal bacteria, and increased the expression of certain cytochrome P450 (CYP450) enzymes and the transporter protein, P-glycoprotein (P-gp), the latter of which was considered evidence that Splenda or sucralose might interfere with the absorption of nutrients and drugs. The investigators indicated that the reported changes were attributable to the sucralose present in the product tested. An Expert Panel conducted a rigorous evaluation of this study. In arriving at its conclusions, the Expert Panel considered the design and conduct of the study, its outcomes and the outcomes reported in other data available publicly. The Expert Panel found that the study was deficient in several critical areas and that its results cannot be interpreted as evidence that either Splenda, or sucralose, produced adverse effects in male rats, including effects on gastrointestinal microflora, body weight, CYP450 and P-gp activity, and nutrient and drug absorption. The study conclusions are not consistent with published literature and not supported by the data presented.
doi_str_mv 10.1016/j.yrtph.2009.06.013
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The Expert Panel found that the study was deficient in several critical areas and that its results cannot be interpreted as evidence that either Splenda, or sucralose, produced adverse effects in male rats, including effects on gastrointestinal microflora, body weight, CYP450 and P-gp activity, and nutrient and drug absorption. 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subjects Animals
Body weight
Body Weight - drug effects
Data Interpretation, Statistical
Drug absorption
Evaluation Studies as Topic
Fecal microflora
Gut bacteria
Intestines - drug effects
Intestines - microbiology
Male
P-glycoprotein (P-gp)
P450 enzymes
Product Surveillance, Postmarketing - standards
Rats
Research Design - standards
Safety
Splenda
Sucralose
Sucrose - analogs & derivatives
Sucrose - pharmacology
Sucrose - toxicity
Sweetening Agents - pharmacology
Sweetening Agents - toxicity
Weight gain
title Expert Panel report on a study of Splenda in male rats
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