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Some Studies on Sucralose / Splenda®

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Sugar (Sucrose)Splenda (Sucralose)

Listed in reverse date order, linked to abstracts in MedLine:
  1. The comet assay with 8 mouse organs: results with 39 currently used food additives. Sasaki YF, Kawaguchi S, Kamaya A, Ohshita M, Kabasawa K, Iwama K, Taniguchi K, Tsuda S., Mutation Research 2002 Aug 26;519(1-2):103-19
    We determined the genotoxicity of 39 chemicals currently in use as food additives. . . Of all the additives, dyes were the most genotoxic. . . .Two antioxidants . . . three fungicides . . . and four sweeteners (sodium cyclamate, saccharin, sodium saccharin, and sucralose) also induced DNA damage in gastrointestinal organs. Based on these results, we believe that more extensive assessment of food additives in current use is warranted.
  2. Repeated dose study of sucralose tolerance in human subjects. Baird IM, Shephard NW, Merritt RJ, Hildick-Smith G. Food Chem Toxicol. 2000;38 Suppl 2:S123-9.
    " Two tolerance studies were conducted in healthy human adult volunteers. The first study was an ascending dose study conducted in eight subjects, . . . In the second study, [13 weeks long] subjects consumed either sucralose (n=77) or fructose (50g/day) (n=31) twice daily in single blind fashion. . . . there is no indication that adverse effects on human health would occur from frequent or long-term exposure to sucralose at the maximum anticipated levels of intake. "

    Note: 13 weeks is not very long-term. Also, these were healthy adult volunteers. We would like to see a 6-month study on children with asthma or other immunological illness.

  3. A carcinogenicity study of sucralose in the CD-1 mouse. Mann SW, Yuschak MM, Amyes SJ, Aughton P, Finn JP. Food Chem Toxicol. 2000;38 Suppl 2:S91-7.
    " . . .Sucralose had no adverse effect on survival. . .There were statistically significant increases in the incidence of several non-neoplastic [non-cancer] findings, but these were not considered to be related to sucralose administration. . . . It was concluded that sucralose is not carcinogenic in CD-1 mice. The body weight gain and erythrocyte observations at the 3.0% dietary level were of limited biological significance as they were not accompanied by any histopathologic [change visible under microscope] finding and had no impact on survival. . . . "

    NOTE: This study was done by McNeil Specialty Products Company, the makers of Sucralose/Splenda.

  4. Acute and subchronic toxicity of sucralose. Goldsmith LA. Food Chem Toxicol. 2000;38 Suppl 2:S53-69.
    " . . .There were no toxicologically significant effects observed at the 1.0% or 2.5% dietary levels. However, decreases in food consumption, body weight gain and selected organ weights and ratios as well as splenic and thymic histopathologic changes occurred in rats administered 5.0% for 4 or 8 weeks. . . .These studies establish that sucralose is non-toxic in rodents following acute oral administration. . . . "

    NOTE: This study was done by McNeil Specialty Products Company, the makers of Sucralose/Splenda.

  5. Sucralose: assessment of teratogenic potential in the rat and the rabbit. Kille JW, Tesh JM, McAnulty PA, Ross FW, Willoughby CR, Bailey GP, Wilby OK, Tesh SA. Food Chem Toxicol. 2000;38 Suppl 2:S43-52.
    " The teratogenic potential [the potential to cause malformations of an embryo or fetus] of sucralose was examined . . .There was no evidence of teratogenicity for either species. The only observed response to treatment in rats was a slight increase in water intake. Some adult rabbits receiving 700mg/kg/day exhibited marked gastrointestinal disturbance. . . considered to be responsible for two maternal deaths and four abortions. . . .maternal consumption of high levels of sucralose during the period of organogenesis has no effect on normal foetal development in the rat or rabbit. "

    NOTE: This study was done by McNeil Specialty Products Company, the makers of Sucralose/Splenda.

    One would think that 2 deaths and 4 failed pregnancies in a group of 18 rabbits could be considered an adverse effect.

  6. Sucralose: lack of effects on sperm glycolysis and reproduction in the rat. Kille JW, Ford WC, McAnulty P, Tesh JM, Ross FW, Willoughby CR. Food Chem Toxicol. 2000;38 Suppl 2:S19-29.
    " . . . The decrease in initial average weight for newborn pups probably reflects the increased litter sizes noted for sucralose-treated groups and the reduced food consumption of the dams [mother rats] during gestation and lactation. . . . Caecal enlargement (a common animal response to large doses of indigestible material) occurred in both the F(0) and F(1) parents. Increased kidney weights, . . . Decreased thymus weights [the thymus gland is important to the immune system occurred . . . We conclude from these results that sucralose has no effect on sperm glycolysis or on male or female reproductive performance in the rat. "

    NOTE: This study was done by McNeil Specialty Products Company, the makers of Sucralose/Splenda.

  7. The pharmacokinetics and metabolism of sucralose in the mouse. John BA, Wood SG, Hawkins DR. Food Chem Toxicol. 2000;38 Suppl 2:S107-10.
    " . . . A 20mg/kg intravenous dose was rapidly excreted mainly in the urine (80% in 5 days). . . .Comparison with the intravenous dose indicated that 20-30% of the oral doses was absorbed. Sucralose was excreted almost entirely unchanged . . . Only two minor metabolites were detected, representing 2-8% of urine radioactivity. "

    NOTE: 8% is not zero. If up to 8% of Splenda is metabolized (resulting in matabolites) what are those chemicals doing to the human body over time?

  8. The pharmacokinetics and metabolism of sucralose in the dog. Wood SG, John BA, Hawkins DR. Food Chem Toxicol. 2000;38 Suppl 2:S99-106.
    " The pharmacokinetics and metabolism of sucralose were investigated in dogs following intravenous or oral administration. . . . One urinary metabolite was detected after both intravenous and oral doses and was identified by mass spectrometry as a glucuronic acid conjugate of sucralose. This metabolite accounted for about 15-20% of the intravenous dose but for only about 2-8% of the oral dose."

    NOTE: 8% is not zero. See previous study by John et al. Furthermore, if there is as much as 20% of the sucralose metabolized to other chemicals after intravenous dosing, what about those people who have more permeable gut walls due to illness?

  9. Gas chromatographic method for detection of urinary sucralose: application to the assessment of intestinal permeability. Farhadi A, Keshavarzian A, Holmes EW, Fields J, Zhang L, Banan A.
    " . . . We measured intestinal permeability using 5- and 24-h urine collections in 14 healthy volunteers. . . . Because neither S [sucrolose] nor M [mannitol] is metabolized by intestinal bacteria, and because only a tiny fraction of either sugar is absorbed, this pair of sugar probes appears to be available for absorption throughout the GI tract. Thus, the 24-h urinary concentrations of S and M, or the urinary S/M ratio following an oral dose of a sugar mixture, might be good markers for whole gut permeability. "

    NOTE: Indeed, in a number of other studies, gut permeability was measured by use of sucralose. We have not found studies showing the effects of long term use of sucralose in a human being with a "leaky" gut which would, presumably, result in much higher concentrations of sucralose in the blood, as well as a much higher percentage of sucralose metabolites in the blood.

  10. Neurotoxicity studies on sucralose and its hydrolysis products with special reference to histopathologic and ultrastructural changes. Finn JP, Lord GH. Food Chem Toxicol. 2000;38 Suppl 2:S7-17.
    " . . . No changes were detected in the central nervous system by light or electron microscopy in either of the species that received sucralose or its hydrolysis products. . . . "

    NOTE: There was no neurological damage that could be seen by microscope. That is nice, but is it adequate to determine if there are subtle neurological effects on mood, sleep, learning, or attention?

  11. Abuse of artificial sweetener as differential diagnosis of lactose intolerance Weglage J, Weber P, Fliedner M, Grohmann J, Zass R, Rossi R. Klin Padiatr. 1996 Jan-Feb;208(1):17-8.
    " A two year old dystrophic [weak - a degenerative disorder from inadequate nutrition] boy with chronic diarrhea was described. At the age of 6 month the boy developed a severe gastroenteritis [inflammation of the lining of the stomach and intestine] with a secondary lactase deficiency. Dietary treatment was however not successful and consequently the boy became dystrophic. At last, an abuse of sweetener was diagnosed. "

    NOTE: The offending sweetener is not disclosed in this abstract. Alcohol sweeteners such as sorbitol can cause diarrhea in large doses. Sucralose can cause gastrointestinal problems severe enough to cause death (see #5 above)

  12. Renal mineralization--a ubiquitous lesion in chronic rat studies. Lord GH, Newberne PM. Food Chem Toxicol. 1990 Jun;28(6):449-55.
    " . . . The feeding of sucralose, a new and high-intensity sweetener under regulatory review, resulted in caecal enlargement and an increase in the incidences of renal mineralization and pelvic epithelial hyperplasia. . . . "