BÊTA-GLUCANE

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La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.

Notes

Date

23 février 2024

Nom(s) propre(s), Nom(s) commun(s), Infromation(s) d'origine

Tableau 1. Nom(s) propre(s), Nom commun(s), Information(s) d'origine
Nom(s) propre(s) Nom(s) commun(s) Information(s) d'origine
Matière(s) d'origine Partie(s) Préparation(s)
bêta-D-Glucane
  • beta-D-Glucan
  • bêta-D-Glucane
  • Avena sativa
  • Hordeum vulgare
  • Graine
  • Son
Isolat
bêta-Glucane d'avoine Avena sativa

Références: Nom propre: Charlton et al. 2012; EFSA 2011a,b, 2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Noms communs: Charlton et al. 2012; EFSA 2011a,b, 2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Informations d'origine: USDA 2023; Charlton et al. 2012; Queenan et al. 2007.

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiqué dans le document de référence Compendium des monographies.

Les formes posologiques acceptables pour la voie d'administration orale sont indiquées dans la liste déroulante dans le formulaire web de demande de licence de mise en marché pour les demandes officinales.

Usage(s) ou fin(s)

  • Aide à réduire/diminuer le cholestérol LDL (qui est un des facteurs de risque dans le développement des maladies coronariennes) (Charlton et al. 2012; EFSA 2011a,b,2010; AbuMweiss et al. 2010; SC 2010; Wolever et al. 2010; Delahoy et al. 2009; Queenan et al. 2007; Wood 2007; Biorklund et al. 2005; NECP 2002; Brown et al. 1999; Ripsin et al. 1992).
  • Aide à réduire/diminuer le mauvais cholestérol (qui est un des facteurs de risque dans le développement des maladies coronariennes) (Charlton et al. 2012; EFSA 2011a,b, 2010; AbuMweiss et al. 2010; SC 2010; Wolever et al. 2010; Delahoy et al. 2009; Queenan et al. 2007; Wood 2007; Biorklund et al. 2005; NECP 2002; Brown et al. 1999; Ripsin et al. 1992).
  • Fournit un soutien pour un métabolisme du glucose (postprandial) sain (dans les deux heures suivant un repas) (EFSA 2011a,b; Ulmius et al. 2011; Granfeldt et al. 2008; Panahi et al. 2007; Biorklund et al. 2005; Kabir et al. 2002).
  • Aide à améliorer le métabolisme du glucose (postprandial) (dans les deux heures suivant un repas) (EFSA 2011a,b; Ulmius et al 2011; Granfeldt et al. 2008; Panahi et al. 2007; Biorklund et al. 2005; Kabir et al. 2002).
  • Source de fibres pour le maintien d'une bonne santé (ACIA 2022; IOM 2005). Aide à soutenir et à maintenir un système digestif sain (ACIA 2022; IOM 2005).

Note: Les usages ci-dessus peuvent être combinés sur l'étiquette du produit (par ex., Aide à réduire/diminuer le mauvais cholestérol et à améliorer le métabolisme du glucose).

Dose(s)

Sous-population(s)

Adultes de 18 ans et plus

Quantité(s)

2 à 10 grammes de bêta-glucane, par jour (Charlton et al. 2011; EFSA 2011a,b,2010; AbuMweiss et al. 2010; Queenan et al. 2007; IOM 2005; Johnston et al. 1998; Braaten et al. 1994; Torronen et al. 1992; Uusitupa et al. 1992).

Mode(s) d'emploi

Énoncé non requis.

Durée(s) d'utilisation

Énoncé non requis.

Mention(s) de risque

Précaution(s) et mise(s) en garde

Énoncé non requis.

Contre-indications(s)

Énoncé non requis.

Réaction(s) indésirable(s) connue(s)

Énoncé non requis.

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Doivent être établies conformément aux exigences décrites dans le Règlement sur les produits de santé naturels.

Spécifications

  • Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
  • L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN.

EXEMPLE D'INFO-PRODUIT :

Veuillez consulter la ligne directrice, Étiquetage des produits de santé naturels pour plus de détails.

Info-Produit

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  • EFSA 2011a: Scientific Opinion: Scientific Opinion on the substantiation of health claims related to beta-glucans from oats and barley and maintenance of normal blood LDL-cholesterol concentrations (ID 1236, 1299), increase in satiety leading to a reduction in energy intake (ID 851, 852), reduction of post-prandial glycaemic responses (ID 821, 824), and ‘digestive function' (ID 850) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. [Consulté le 5 février 2024]. Disponible à : http://www.efsa.europa.eu/en/efsajournal/doc/2207.pdf
  • EFSA 2011b: Scientific Opinion: Scientific Opinion on the substantiation of a health claim related to barley beta-glucans and lowering of blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 or Regulation (EC) No 1924/2006. EFSA Panel on Dietetic Products, Nutrition and Allergies (DNA), European Food Safety Authority (EFSA), Parma, Italy. [Consulté le 5 février 2024]. Disponible à : http://www.efsa.europa.eu/en/efsajournal/doc/2471.pdf
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