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Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7015520/ https://www.ncbi.nlm.nih.gov/pubmed/32626054 http://dx.doi.org/10.2903/j.efsa.2018.e16083 |
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author | Marakis, G Ziegenhagen, R Lampen, A Hirsch‐Ernst, KI |
author_facet | Marakis, G Ziegenhagen, R Lampen, A Hirsch‐Ernst, KI |
collection | PubMed |
description | Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as food supplements, they may appeal to people who are suffering from metabolic syndrome and/or diabetes mellitus. A scientific literature search was carried out using PubMed/MEDLINE and EMBASE electronic databases. Experience was gained by the fellow in systematic data extraction from scientific publications, structuring of the data and evaluating toxicological key parameters, outcomes of clinical significance, pharmacokinetic and pharmacodynamic interactions, uncertainties and methodological shortcomings of studies. Limited evidence from toxicological in vivo studies and human clinical studies suggested lack of relevant adverse effects of this botanical. However, human studies provided some indications that certain Gymnema extracts may enhance the glucose‐lowering effects of certain antidiabetic drugs. Considering the uncertainties for the composition of different Gymnema preparations, potential herb–drug interactions and the indications of glucose lowering or hypoglycaemic effects, the use of Gymnema‐based food supplements in combination with authorised antidiabetic drugs may be associated with risks. The procedures learned for the safety evaluation of Gymnema may be similarly applied by the fellow for the risk assessment of other substances with nutritional or physiological effect added to foods and food supplements. Furthermore, apart from learning by conducting exercises in risk assessment, the fellow was able to develop other skills (e.g. communication skills), diversify his competencies and expand his network of scientific connections for future collaborations in the field of nutritional risk assessment. |
format | Online Article Text |
id | pubmed-7015520 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70155202020-07-02 Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre Marakis, G Ziegenhagen, R Lampen, A Hirsch‐Ernst, KI EFSA J EU‐FORA: Series 1 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as food supplements, they may appeal to people who are suffering from metabolic syndrome and/or diabetes mellitus. A scientific literature search was carried out using PubMed/MEDLINE and EMBASE electronic databases. Experience was gained by the fellow in systematic data extraction from scientific publications, structuring of the data and evaluating toxicological key parameters, outcomes of clinical significance, pharmacokinetic and pharmacodynamic interactions, uncertainties and methodological shortcomings of studies. Limited evidence from toxicological in vivo studies and human clinical studies suggested lack of relevant adverse effects of this botanical. However, human studies provided some indications that certain Gymnema extracts may enhance the glucose‐lowering effects of certain antidiabetic drugs. Considering the uncertainties for the composition of different Gymnema preparations, potential herb–drug interactions and the indications of glucose lowering or hypoglycaemic effects, the use of Gymnema‐based food supplements in combination with authorised antidiabetic drugs may be associated with risks. The procedures learned for the safety evaluation of Gymnema may be similarly applied by the fellow for the risk assessment of other substances with nutritional or physiological effect added to foods and food supplements. Furthermore, apart from learning by conducting exercises in risk assessment, the fellow was able to develop other skills (e.g. communication skills), diversify his competencies and expand his network of scientific connections for future collaborations in the field of nutritional risk assessment. John Wiley and Sons Inc. 2018-08-28 /pmc/articles/PMC7015520/ /pubmed/32626054 http://dx.doi.org/10.2903/j.efsa.2018.e16083 Text en © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | EU‐FORA: Series 1 Marakis, G Ziegenhagen, R Lampen, A Hirsch‐Ernst, KI Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre |
title | Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
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title_full | Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
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title_fullStr | Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
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title_full_unstemmed | Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
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title_short | Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
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title_sort | risk assessment of substances used in food supplements: the example of the botanical gymnema sylvestre |
topic | EU‐FORA: Series 1 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7015520/ https://www.ncbi.nlm.nih.gov/pubmed/32626054 http://dx.doi.org/10.2903/j.efsa.2018.e16083 |
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