Genotoxicity testing of a fenugreek extract

• Published in: Food and chemical toxicology 2004-11, Vol.42 (11), p.1769-1775
• Main Authors: Flammang, A.M., Cifone, M.A., Erexson, G.L., Stankowski, L.F.
• Format: Article
• Language: English
• Subjects: Animals; Biological and medical sciences; Blood Glucose - drug effects; Blood Glucose - metabolism; cell culture; cell lines; chemical composition; Consumer Product Safety; Diabetes Mellitus - drug therapy; Diabetes Mellitus - metabolism; DNA damage; dose response; Dose-Response Relationship, Drug; Escherichia coli; Extract; Fenugreek; flavorings; free amino acids; genotoxicity; glycemic control; glycemic effect; herbs; Humans; Hypoglycemic Agents - therapeutic use; Hypoglycemic Agents - toxicity; ingredients; lymphoma; Male; Medical sciences; medicinal plants; Mice; Mice, Inbred Strains; Micronucleus Tests; Mouse lymphoma forward mutation assay; Mouse micronucleus assay; Mutagenicity Tests; No-Observed-Adverse-Effect Level; Plant Extracts - toxicity; Plants, Medicinal; Reverse mutation assay; Safety; safety testing; Salmonella typhimurium; seed extracts; Seeds - toxicity; toxicity testing; Toxicology; traditional medicine; Trigonella - toxicity; Trigonella foenum graecum; United States; United States Food and Drug Administration; viability
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2004.07.003

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.