title: Genotoxicity testing of a fenugreek extract.
abstract: Fenugreek seeds have been used in traditional medicines as a remedy for diabetes. Rich in protein, fenugreek seeds contain the unique major free amino acid 4-hydroxyisoleucine (4-OH-Ile), which has been characterized as one of the active ingredients for blood glucose control. Current use of fenugreek in foodstuff has been limited to its role as a flavoring agent, and not as an ingredient to help mitigate the blood glucose response for people with diabetes. As part of a safety evaluation of novel ingredients for use in blood glucose control, the potential genotoxicity of a fenugreek seed extract (THL), containing a minimum of 40% 4-OH-ILE, was evaluated using the standard battery of tests (reverse mutation assay; mouse lymphoma forward mutation assay; mouse micronucleus assay) recommended by US Food and Drug Administration (FDA) for food ingredients. THL was determined not to be genotoxic under the conditions of the tested genetic toxicity battery. The negative assay results provide support that addition of THL to foodstuffs formulated for people with diabetes is expected to be safe. A wide safety margin is established, as anticipated doses are small compared to the doses administered in the assays.
authors.affiliation: Ross Products Division, Abbott Laboratories, 624 Cleveland Ave, Columbus, OH 43215-1724, USA. ann.flammang@abbott.com
authors.forename: A M
authors.initials: AM
authors.lastname: Flammang
authors.forename: M A
authors.initials: MA
authors.lastname: Cifone
authors.forename: G L
authors.initials: GL
authors.lastname: Erexson
authors.forename: L F
authors.initials: LF
authors.lastname: Stankowski
mesh_terms: D000818:Animals; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D003257:Consumer Product Safety; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004926:Escherichia coli; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use / Q000633:toxicity; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000633:toxicity*; D010946:Plants, Medicinal; D012486:Salmonella typhimurium; D012639:Seeds / Q000633:toxicity; D029910:Trigonella / Q000633:toxicity*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D010936:Plant Extracts