Safety evaluation and nutritional composition of a Fraxinus excelsior seed extract, FraxiPure™

Food and Chemical Toxicology

Volumn 53, Issue , 2013, Pages 10-17

  Flanagan, John ^a   Meyer, Marjolaine ^a   Pasamar, María Angeles ^a   Ibarra, Alvin ^b   Roller, Marc ^c   Alvarez i Genoher, Nuria ^d   Leiva, Sandra ^e   Gomez García, Francisco ^f   Alcaraz, Miguel ^f   Martínez Carrasco, Alberto ^f   Vicente, Vicente ^f  

^a Naturex Spain SL ^*  (Spain)

^b Naturex Inc   (United States)

^c Givaudan SA   (Switzerland)

^d Lab de Analisis Dr Echevarne   (Spain)

^e Centro Tecnologico Ainia   (Spain)

^f UNIVERSITY OF MURCIA   (Spain)

Author keywords

Clinical safety; FraxiPure ; GI3; Nuzhenide; Secoiridoid; Toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CARBOHYDRATE; CREATININE; FRAXINUS EXCELSIOR EXTRACT; FRAXIPURE; GAMMA GLUTAMYLTRANSFERASE; GLUCOSE; LACTOSE; MALTODEXTRIN; MALTOSE; PLACEBO; PROTEIN; SECOIRIDOID; SUCROSE; UNCLASSIFIED DRUG;

ACUTE TOXICITY; ADULT; AGED; ANIMAL CELL; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; CYTOTOXICITY; DIETARY FIBER; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENOTOXICITY; HEMATOLOGICAL PARAMETERS; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; LD 50; LYMPHOCYTE; MALE; MICRONUCLEUS; MICRONUCLEUS TEST; MOUSE; NONHUMAN; NORMAL HUMAN; NUTRITIONAL VALUE; PLANT SEED; RADIATION PROTECTION; TOXICITY TESTING;

ADOLESCENT; ADULT; AGED; ANIMALS; AREA UNDER CURVE; BLOOD GLUCOSE; CERCOPITHECUS AETHIOPS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG EVALUATION, PRECLINICAL; FEMALE; FRAXINUS; HUMANS; INHIBITORY CONCENTRATION 50; LETHAL DOSE 50; LYMPHOCYTES; MALE; METALS, HEAVY; MIDDLE AGED; NUTRITIVE VALUE; PESTICIDES; PLANT EXTRACTS; RATS; RATS, SPRAGUE-DAWLEY; SEEDS; VERO CELLS; YOUNG ADULT;

ANIMALIA; FRAXINUS EXCELSIOR; RATTUS;

EID: 84871422676     PISSN: 02786915     EISSN: 18736351     Source Type: Journal    
DOI: 10.1016/j.fct.2012.11.030     Document Type: Article

References (42)

1. Alcaraz M., Armero D., Martinez-Beneyto Y., Castillo J., Benavente-Garcia O., Fernandez H., Alcaraz-Saura M., Canteras M. Chemical genoprotection: reducing biological damage to as low as reasonably achievable levels. Dentomaxillofac. Radiol. 2011, 40:310-314.
2. Alley M.C., Scudiero D.A., Monks A., Hursey M.L., Czerwinski M.J., Fine D.L., Abbott B.J., Mayo J.G., Shoemaker R.H., Boyd M.R. Feasibility of drug screening with panels of human tumor cell lines using a microculture tetrazolium assay. Cancer Res. 1988, 48:589.
3. AOAC, 1995. Official Methods of Analysis 991.43. Total soluble and insoluble dietary fibre in foods.
4. AOAC, 2002. Official Methods of Analysis 990.08. Metals in solid wastes by inductively coupled plasma atomic emission method.
5. AOAC, 2006a. Official Methods of Analysis 977.20. Separation of sugars in honey.
6. AOAC, 2006b. Official Methods of Analysis 986.15. Arsenic, cadmium, lead, selenium and zinc in human and pet foods.
7. AOAC, 2006c. Official Methods of Analysis 999.11. Lead, cadmium, cooper, iron and zinc in foods.
8. Bai N., He K., Ibarra A., Bily A., Roller M., Chen X., Ruhl R. Iridoids from Fraxinus excelsior with adipocyte differentiation-inhibitory and PPAR-alpha activation activity. J. Nat. Prod. 2010, 73:2-6.
9. Carmichael J., DeGraff W.G., Gazdar A.F., Minna J.D., Mitchell J.B. Evaluation of a tetrazolium-based semiautomated colorimetric assay: assessment of chemosensitivity testing. Cancer Res. 1987, 47:936.
10. Eddouks M., Maghrani M. Phlorizin-like effect of Fraxinus excelsior in normal and diabetic rats. J. Ethnopharmacol. 2004, 94:149-154.
11. Eddouks M., Maghrani M., Zeggwagh N.A., Haloui M., Michel J.B. Fraxinus excelsior L. evokes a hypotensive action in normal and spontaneously hypertensive rats. J. Ethnopharmacol. 2005, 99:49-54.
12. El-Ghazaly M., Khayyal M.T., Okpanyi S.N., Arens-Corell M. Study of the anti-inflammatory activity of Populus tremula, Solidago virgaurea and Fraxinus excelsior. Arznei mittel-Forshung 1992, 42:333-336.
13. European Pharmacopoeia, 2008. 6th edn. Pesticide residues. 6.2-3637. European Department for the Quality of Medicines, Strasbourg, France.
14. European Pharmacopoeia, 2009. 6th edn. Microbial examination of non-sterile products: microbial enumeration test. 6.7-5594. European Department for the Quality of Medicines, Strasbourg, France.
15. Fenech M. Cytokinesis-block micronucleus cytome assay. Nat. Protoc. 2007, 2:1084-1104.
16. Fenech M., Morley A.A. Measurement of micronuclei in lymphocytes. Mutat. Res. Environ. Muta. 1985, 147:29-36.
17. Finck B.N., Bernal-Mizrachi C., Han D.H., Coleman T., Sambandam N., LaRiviere L.L., Holloszy J.O., Semenkovich C.F., Kelly D.P. A potential link between muscle peroxisome proliferator-activated receptor alpha signaling and obesity-related diabetes. Cell Metab. 2005, 1:133-144.
18. Gundermann K.J., Muller J. Phytodolor - effects and efficacy of a herbal medicine. Wien. Med. Wochenschr. 2007, 157:343-347.
19. Ibarra A., Bai N., He K., Bily A., Cases J., Roller M., Sang S. Fraxinus excelsior seed extract FraxiPure™ limits weight gains and hyperglycemia in high-fat diet-induced obese mice. Phytomedicine 2011, 18:479-485.
20. IEAE Cytogenetic Analysis for Radiation Dose Assessment. A Manual 2001, IEAE, Vienna, Austria.
21. ISO Microbiology of Food and Animal Feedings Stuffs - Horizontal Method for the Enumeration of Coagulase-Positive Staphylococci (Staphylococcus aureus and Other Species). ISO 6888-1:2000 2000, International Organization for Standardization, Geneva, Switzerland.
22. ISO Microbiology of Food and Animal Feeding Stuffs - Horizontal Method for the Enumeration of Microorganisms - Colony-Count Technique at 30 °C. ISO 4833:2003 2003, International Organization for Standardization, Geneva, Switzerland.
23. ISO Microbiology of Food and Animal Feeding Stuffs. Horizontal Method for the Detection of Salmonella spp. ISO 6579:2003 2003, International Organization for Standardization, Geneva, Switzerland.
24. Kang H.S., Matsuo T., Suzuki M. Effects of light resistance exercise using dumbbells and rubber band with mild energy restriction on body composition and physical fitness in obese Korean women. Asia Pac. J. Clin. Nutr. 2004, 13:242-247.
25. Kostova I., Iossifova T. Chemical components of Fraxinus species. Fitoterapia 2007, 78:85-106.
26. Lefebvre P., Chinetti G., Fruchart J.C., Staels B. Sorting out the roles of PPAR alpha in energy metabolism and vascular homeostasis. J. Clin. Invest. 2006, 116:571-580.
27. Maghrani M., Zeggwagh N., Lemhadri A., El Amraoui M., Michel J., Eddouks M. Study of the hypoglycaemic activity of Fraxinus excelsior and Silybum marianum in an animal model of type 1 diabetes mellitus. J. Ethnopharmacol. 2004, 91.
28. MAPA Métodos oficiales de análisis de alimentos. Ministerio de Agricultura, Pesca y Alimentación 1994, Mundi-Prensa Libros S.A., Madrid.
29. Meyer B., Schneider W., Elstner E.F. Antioxidative properties of alcoholic extracts from Fraxinus excelsior, Populus tremula and Solidago virgaurea. Arznei mittel-Forshung 1995, 45:174-176.
30. Middleton P., Stewart F., Al-Qahtani S., Egan P., O'Rourke C., Abdulrahman A., Byres M., Middleton M., Kumarasamy Y., Shoeb M., Nahar L., Delazar A., Sarker S. Antioxidant, antibacterial activities and general toxicity of Alnus glutinosa, Fraxinus excelsior and Papaver rhoeas. Iran. J. Pharm. Res. 2005, 2:81-86.
31. OECD Guideline for Testing of Chemicals. Guideline 423 1996, Organisation for Economic Co-operation and Development, Paris, France.
32. OECD In Vitro Micronucleus Test. Guideline 487 2004, Organisation for Economic Co-operation and Development, Paris, France.
33. Okpanyi S.N., Schirpke-von Paczensky R., Dickson D. Anti-inflammatory, analgesic and antipyretic effect of various plant extracts and their combinations in an animal model. Arznei mittel-Forshung 1989, 39:698-703.
34. Parsa A. Medicinal plants and drugs of plant origin in Iran III. Plant Foods Hum. Nutr. 1959, 6:137-156.
35. Real Decreto, 2009. RD 1669/2009 de 6 de Noviembre de 2009. Boletín Oficial del Estado 7 de Noviembre. Num 269. Sec. I, 9256-9259.
36. Sarma L., Kesavan P.C. Protective effects of vitamins C and E against gamma-ray-induced chromosomal damage in mouse. Int. J. Radiat. Biol. 1993, 63:759-764.
37. Schempp H., Weiser D., Elstner E.F. Biochemical model reactions indicative of inflammatory processes. Activities of extracts from Fraxinus excelsior and Populus tremula. Arznei mittel-Forshung 2000, 50:362-372.
38. Scott F.W. HPLC determination of carbohydrates in foods. Food Analysis by HPLC 1992, 259-274. Marcel Dekker Inc., New York. L.M.L. Nollet (Ed.).
39. Strehl E., Schneider W., Elstner E.F. Inhibition of dihydrofolate reductase activity by alcoholic extracts from Fraxinus excelsior, Populus tremula and Solidago virgaurea. Arznei mittel-Forshung 1995, 45:172-173.
40. Szakova J., Kolihova D., Miholova D., Mader P. Single-purpose atomic absorption spectrometer AMA-254 for mercury determination and its performance in analysis of agricultural and environmental materials. Chem. Pap. 2004, 58:311-315.
41. Visen P., Saraswat B., Visen A., Roller M., Bily A., Mermet C., He K., Bai N., Lemaire B., Lafay S., Ibarra A. Acute effects of Fraxinus excelsior L. seed extract on postprandial glycemia and insulin secretion on healthy volunteers. J. Ethnopharmacol. 2009, 126:226-232.
42. von Kruedener S., Schneider W., Elstner E. Effects of extracts from Populus tremula L., Solidago virgaurea L. and Fraxinus excelsior L. on various myeloperoxidase systems. Arznei mittel-Forshung 1996, 46:809-814.