Repeated dose study of sucralose tolerance in human subjects
| Autor: | I M Baird, Russell J. Merritt, G Hildick-Smith, N W Shephard |
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| Rok vydání: | 2000 |
| Předmět: |
Adult
Male medicine.medical_specialty Sucralose Sucrose Urinalysis Adolescent Physiology Administration Oral Toxicology Gas Chromatography-Mass Spectrometry law.invention chemistry.chemical_compound Pharmacokinetics Randomized controlled trial Oral administration law Internal medicine Medicine Humans Insulin Single-Blind Method Dosing Adverse effect Chromatography High Pressure Liquid Hematologic Tests medicine.diagnostic_test business.industry General Medicine Middle Aged Ophthalmoscopy Endocrinology chemistry Sweetening Agents Toxicity Female business Blood Chemical Analysis Food Science |
| Zdroj: | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 38 |
| ISSN: | 0278-6915 |
| Popis: | Two tolerance studies were conducted in healthy human adult volunteers. The first study was an ascending dose study conducted in eight subjects, in which sucralose was administered at doses of 1, 2. 5, 5 and 10mg/kg at 48-hour intervals and followed by daily dosing at 2mg/kg for 3 days and 5mg/kg for 4 days. In the second study, subjects consumed either sucralose (n=77) or fructose (50g/day) (n=31) twice daily in single blind fashion. Sucralose dosage levels were 125mg/day for weeks 1-3, 250mg/day during weeks 4-7, and 500mg/day during weeks 8-12. No adverse experiences or clinically detectable effects were attributable to sucralose in either study. Similarly, haematology, serum biochemistry, urinalysis and EKG tracings were unaffected by sucralose administration. In the 13-week study, serial slit lamp ophthalmologic examination performed in a random subset of the study groups revealed no changes. Fasting and 2-hour post-dosing blood sucralose concentrations obtained daily during week 12 of the study revealed no rising trend for blood sucralose. Sucralose was well tolerated by human volunteers in single doses up to 10mg/kg/day and repeated doses increasing to 5mg/kg/day for 13 weeks. Based on these studies and the extensive animal safety database, 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. |
| Databáze: | OpenAIRE |
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