C.W. Sham praises sucralose in 2005, citing 4 industry funded studies
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[ C. W. Sham praises sucralose, citing just four industry funded human studies on small groups at low doses for 17 days, 13 weeks, and 3 months. ]
Nutrition Bytes [ not in PubMed ]
Volume 10, Issue 2 2005 Article 5
Splenda - A Safe and Sweet Alternative to Sugar
Caroline W. Sham
David Geffen School of Medicine at UCLA, email@example.com
Copyright 2005 by the authors, unless otherwise noted.
This article is part of the collected
publications of Nutrition Bytes.
Nutrition Bytes is produced by the eScholarship Repository
Produced by eScholarship Repository, 2007
Department of Biological Chemistry, UCLA,
David Geffen School of Medicine
University of California, Los Angeles
Felice Kurtzman, M.P.H., R.D., Co-Chief Editor
Eryn Ujita Lee, Ph.D., Co-Chief Editor
Asst Adjt Prof
firstname.lastname@example.org 310-825-9356 Biol Chem 1445
John Edmond, Ph.D.
Leonard Rome, Ph.D.
Rome, Leonard H.
Sr Assoc Dean Res
David Geffen Sch of Med, Ofc of the Dean 1400
[ Excerpt ]
SUCRALOSE IS SAFE FOR HUMAN CONSUMPTION
The FDA has concluded that sucralose does not pose carcinogenic, reproductive, or neurological risks to human beings (8).
So, what kind of direct evidence exists regarding sucralose safety?
Baird et al. performed a pair of sucralose tolerance studies.
The first was an observational study conducted on eight subjects over a period of 17 days with an ascending dose scheme (range 1-10 mg/kg body weight/day).
The second was a multicenter, single-blind, randomized, controlled study on 118 subjects over 13 weeks, comparing repeated doses of sucralose (range 125-500 mg/day) to fructose.
Neither study resulted in any positive hematologic, serum biochemistry, urinary, cardiac, or ophthalmologic findings.
Sucralose was found to be well tolerated in single doses up to
10 mg/kg/day and repeated doses increasing to 5 mg/kg/day for 13 weeks (9).
So, there have been no documented adverse effects due to short-term sucralose consumption.
Since diabetics are a group in need of sugar alternatives, human sucralose consumption has been studied in this population.
A comparative observational study on 16 male subjects with well-controlled type 2 diabetes found that a diet incorporating fat
replacers and sucralose yielded better improvements in metabolic and anthropometric variables, as compared to the currently recommended American Diabetic Association diet (10).
A multi-center, double-blind, randomized, placebo-controlled study on 128 obese subjects with type 2 diabetes examined the effects of sucralose on metabolic profiles as compared to placebo.
There were no significant differences between the groups in
measured HbA1c, fasting plasma glucose, or fasting serum C-peptide, showing that sucralose consumption for 3 months at a dose of 7.5 mg/kg/day (estimated to be three times the average maximum intake) does not affect glucose homeostasis in type 2 diabetics (11).
In summary, sucralose is well tolerated in both healthy and diabetic
8. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; Sucralose. 1998, 21CFR172.64.
9. Baird IM, Shephard NW, Merritt RJ, et al. Repeated Dose Study of Sucralose Tolerance in Human Subjects. Food and Chem Tox. 2000; 28: S123-129.
I. McLean Baird a, N. W. Shephard b, R. J. Merritt c and G. Hildick-Smith d
a Pine Court, Fairbourne, Cobham, Surrey KT11 2BT, UK
Present address: Ross Labs, 151 South Parkview, Columbus, OH 43209, USA.
b Medical Science Research, Brambles, Granborough, Bucks, MK18 3NT, UK
c McNeil Specialty Products Company, 501 George St, New Brunswick, NJ 08903, USA
d Johnson & Johnson, World Tower, One Plaza, New Brunswick, NJ 08903, USA
10. Reyna NY, Cano C, Bermudez VJ, et al. Sweeteners and beta-glucans improve metabolic and anthropometrics variables in well controlled type 2 diabetic patients. Am J Ther. 2003; 10: 538- 43.
Endocrine and Metabolic Research Center, Nutrition School, University of Zulia, Maracaibo, Venezuela. email@example.com
11. Grotz VL, Henry RR, McGill JB, et al. Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. J Am Diet Assoc. 2003; 103: 1607-1612.
Medical and Nutritional Affairs, McNeil Nutritionals, New Bruswick, NJ 08903-2400, USA. firstname.lastname@example.org
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