Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy SubjectsReportar como inadecuado




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In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation ResistAidTM was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo n = 98 or an arabinogalactan preparation n = 101 over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group p = 0.935. There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as -very good- or -good- by the investigators for 99% of the subjects and by 98% subjects in self-assessment with no statistical differences to placebo. CONCLUSION: The measured parameters as well as the evaluation of the tolerability by the investigators and the subjects demonstrate a very good tolerance profile of the proprietary arabinogalactan extract with no differences to placebo when taken for 12 weeks.

KEYWORDS

Randomized Placebo-Controlled Study; Proprietary Larch Arabinogalactan; Safety; Tolerability; Resist AidTM

Cite this paper

B. Grube, H. Stier, L. Riede and J. Gruenwald -Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy Subjects,- Food and Nutrition Sciences, Vol. 3 No. 11, 2012, pp. 1533-1538. doi: 10.4236-fns.2012.311200.





Autor: Barbara Grube, Heike Stier, Linda Riede, Joerg Gruenwald

Fuente: http://www.scirp.org/



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