Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5850569 | Food and Chemical Toxicology | 2014 | 9 Pages |
Abstract
Calcium β-hydroxy-β-methylbutyrate-monohydrate (CaHMB) is a dietary supplement used as an ergogenic aid and in functional and medical foods. A new delivery form has been developed, β-hydroxy-β-methylbutyric free acid (HMBFA), which has improved bioavailability. While the safety of CaHMB is well documented, there are few published studies demonstrating the safety of HMBFA. Because HMBFA results in greater serum levels of β-hydroxy-β-methylbutyrate (HMB) and greater clearance rates, a 91-day subchronic toxicity study was conducted in male and female Sprague-Dawley Crl:CD rats assigned to HMBFA treatments at either 0%, 0.8%, 1.6%, or 4% of the diet by weight. No deaths or untoward clinical observations, and no negative clinical chemistry or hematology were attributed to the administration of HMBFA. Gross pathology and histopathology results showed no tissue abnormalities due to HMBFA and all measures were within a normal physiological range for the animals or were expected in the population studied. In conclusion, the no-observed-adverse-event-level (NOAEL) for HMBFA was the highest level administered, 4% of the diet, which corresponded to an intake of 2.48 and 2.83 g/kg BW dâ1 in the males and females, respectively. The equivalent human dosage using body surface area conversion would be 402 and 459 mg/kg BW dâ1 for men and women, respectively.
Keywords
MCHA/G RATIOFDAGLPNOAELMCVMCHCALTmTORGGTHmbRDWASTAspartate aminotransferaseAlanine aminotransferaseβ-Hydroxy-β-methylbutyrateanalysis of varianceANOVAGood Laboratory PracticeMean corpuscular volumeOralFood and Drug AdministrationToxicityRed cell distribution widthmean corpuscular hemoglobinRatMean corpuscular hemoglobin concentrationAlbumin to globulin ratiomammalian target of rapamycinno-observed-adverse-effect-levelGamma-glutamyltransferase
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Authors
John C. Jr., Lawrence H. Arp, Lisa M. Diehl, Kelly L. Landin, Shawn M. Baier, John A. Rathmacher,