Genotoxicity testing of a fenugreek extract

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 fenugree...

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Veröffentlicht in:Food and chemical toxicology 2004-11, Vol.42 (11), p.1769-1775
Hauptverfasser: Flammang, A.M., Cifone, M.A., Erexson, G.L., Stankowski, L.F.
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container_end_page 1775
container_issue 11
container_start_page 1769
container_title Food and chemical toxicology
container_volume 42
creator Flammang, A.M.
Cifone, M.A.
Erexson, G.L.
Stankowski, L.F.
description 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.
doi_str_mv 10.1016/j.fct.2004.07.003
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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. 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source MEDLINE; Elsevier ScienceDirect Journals Complete
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
title Genotoxicity testing of a fenugreek extract
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