title: Long-term safety evaluation of a novel oxygen-coordinated niacin-bound chromium (III) complex.
abstract: Chromium (III) is an essential micronutrient required for normal protein, fat and carbohydrate metabolism, as well as helps insulin metabolize fat, turn protein into muscle and convert sugar into energy. A broad spectrum of research investigations including in vitro, in vivo and clinical studies demonstrated the beneficial effects of novel oxygen- coordinated niacin-bound chromium (III) complex (NBC) in promoting glucose-insulin sensitivity, lipid profile, cardioprotective ability and lean body mass. This study examined the long-term safety of NBC by orally administering either 0 or 25 ppm or the human equivalency dose of 1000 microg elemental chromium (III) as NBC per day for 52 consecutive weeks to male and female Sprague-Dawley rats. Animals of each group and each gender were sacrificed on 26, 39, or 52 weeks of treatment. Body weight, physical and ocular health, feed and water intake, selected organ weights as such and as a percentage of liver and brain weight, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological evaluations were conducted. At 26, 39, or 52 weeks of treatment, body weight gain was significantly reduced by 7.7%, 8.1% and 14.9% in male rats, and 5.5%, 11.4% and 9.6% in female rats, respectively, in the NBC treatment groups. No significant changes were observed in hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological evaluation between control and NBC groups at these time points. These findings, thus far, are in agreement with the subchronic studies in terms of the safety of NBC.
authors.affiliation: Creighton University Medical Center, Omaha, NE, USA. mshara@creighton.edu
authors.forename: Michael
authors.initials: M
authors.lastname: Shara
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Kincaid
authors.forename: Aimee L
authors.initials: AL
authors.lastname: Limpach
authors.forename: Robert
authors.initials: R
authors.lastname: Sandstrom
authors.forename: Laura
authors.initials: L
authors.lastname: Barrett
authors.forename: Neil
authors.initials: N
authors.lastname: Norton
authors.forename: J D
authors.initials: JD
authors.lastname: Bramble
authors.forename: Taharat
authors.initials: T
authors.lastname: Yasmin
authors.forename: Janet
authors.initials: J
authors.lastname: Tran
authors.forename: Archana
authors.initials: A
authors.lastname: Chatterjee
authors.forename: Manashi
authors.initials: M
authors.lastname: Bagchi
authors.forename: Debasis
authors.initials: D
authors.lastname: Bagchi
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D001921:Brain / Q000187:drug effects / Q000254:growth & development; D017608:Chromium Compounds / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D053938:DNA Fragmentation / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D015227:Lipid Peroxidation / Q000187:drug effects; D008099:Liver / Q000187:drug effects / Q000254:growth & development / Q000378:metabolism; D008297:Male; D009525:Niacin / Q000737:chemistry*; D009929:Organ Size / Q000187:drug effects; D010100:Oxygen / Q000737:chemistry*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013810:Therapeutic Equivalency; D013997:Time Factors
chemical_list: D017608:Chromium Compounds; D009525:Niacin; D010100:Oxygen