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Ukushicilelwa kuyatholakala ku-https://www.gov.uk/government/publications/uknhcc-scientific-opinion-white-mulberry-leaf-extract-and-blood-glucose-levels/scientific-opinion-for-the-substantiation .ukuthola-izimangalo-zezempilo-kokunye-ingxenye-kusuka-mhlophe-mulberry-extract-nosizo-impilo-bl
I-UKNHCC Code of Conduct ithi izibukeli ezisemthethweni ziba khona emihlanganweni ye-UKNHCC ukuze zinikeze ulwazi lwakamuva mayelana nezindaba zamanje zesayensi nenqubomgomo emazweni abo kuyilapho zihlonipha ukuzimela kwe-UKNHCC.
UKNHCC (UK Nutrition and Health Claims Council), 2023 Reserved Scientific Opinion (EC) No 1924/2006, Nutritional Regulations (Izichibiyelo njll.) (Ukushiya i-EU) kanye Nemithethonqubo Yezokudla (Izichibiyelo njll.) .) (ukuhoxa ku-EU) 2020 njengoba uchitshiyelwe.
Lo mbono awukona futhi akufanele uthathwe njengokugunyazwa kokumaketha kweqabunga likamalibhele, ukuhlola okuhle kokuphepha kwalo, futhi akusona isahlulelo sokuthi ingabe ukukhishwa kweqabunga likamalibhele kuhlukaniswa njengomkhiqizo wokudla.Kufanele kuqashelwe ukuthi lolu hlobo lokulawula aluhlinzekwanga ngaphansi koMthetho Wokudla (Ukuchitshiyelwa, njll.) (Ukushiya i-EU) Regulation 2019 kanye ne-Food Preservation (Amendment) Regulation (EC) No 1924/2006 [umbhalo waphansi 1], njll. .) (Ukushiya i-EU) Umthethonqubo ka-2020
Kufanele futhi kugcizelelwe ukuthi ububanzi, amagama ahlongozwayo ezimangalo kanye nemibandela yokusetshenziswa ehlongozwe ngumfakisicelo ingashintsha ngaphambi kokuphothulwa kwenqubo yesibonelelo sikahulumeni ehlinzekwe ku-Article 18(4) ye-Savings Regulation (EC) Cha 1924/2006 [umbhalo waphansi 1] Njengoba uchitshiyelwe, Ngokudla (Isichibiyelo, njll.) (Ukushiya i-EU) Imithetho 2019 kanye Nokudla (Izichibiyelo, njll.) (Ukushiya i-EU) Imithetho 2020.
Izicelo zamukelwe yi-UKNHCC ngomhlaka-5 Agasti 2022 futhi inqubo yokuhlola yesayensi yaqala ngokushesha.
Ngo-Agasti 19, 2022, ukuhlola kwesayensi kwamiswa ngemva kwenqubo “yokumisa iwashi” edinga abafake izicelo ukuthi banikeze ulwazi olwengeziwe.
Ngomhla zizi-4 Septhemba 2022, i-UKNHCC yathola ulwazi olwengeziwe futhi yaqala kabusha ukuhlola kwesayensi ngokuhambisana ne-Athikili 16(1) Yomthethonqubo (EC) No 1924/2006.
Ukugunyazwa kokwenza izimangalo zezempilo ngaphansi kwe-Article 14(1)(a) Surviving Regulation (EC) No 1924/20061 njengoba uchitshiyelwe Umthetho Wokudla (Ukuchitshiyelwa, njll.) (ukuhoxa ku-European Union) 2019 futhi wakhishwa isiphathimandla esinekhono sase-UK .Igunya kuhlelo lokusebenza lwe-Ascarit UK.Ku- Nutrition (Amendment, njll.) (Leaving the EU) Regulations 2020, I-UK Nutrition and Health Claims Committee (UKNHCC) yacelwa ukuba iphawule ngesisekelo sesayensi sezicelo zezempilo zamaqabunga kamalibhele (M. alba).okukhishwayo "kufakazelwa ngokomtholampilo ukusiza ukugcina amazinga kashukela egazini enempilo."
Kuphakanyiswe ukuthi ububanzi besicelo bube ngaphansi kwezidingo zezempilo ezihlobene nokunciphisa ubungozi besifo, okuhlanganisa nesicelo sokuvikelwa kobumfihlo, esahoxiswa kamuva.
Umkhiqizo wokudla okunomsoco okuthiwa unempilo uyisiqephu esisodwa samaqabunga e-M. alba (umalibhele omhlophe).
Ngokombono weKomidi, ukukhishwa okunomsoco kwamaqabunga e-M. alba akubonakali ngokwanele ngezimangalo ezihlongozwayo.
Isimangalo somfakisicelo siwukuthi i-M. alba leaf extract "ifakazelwa ngokomtholampilo ukusiza ukugcina amazinga kashukela egazini enempilo."Isici esiyingozi esibeka engcupheni kwaba ushukela wegazi ophakeme futhi isifo esihlobene nengozi kwakuwuhlobo 2 sikashukela.Iqembu elihlosiwe elihlosiwe "yiziguli ezinesifo sikashukela sohlobo 2".Imiphumela enjalo efunwayo ingaphandle kobubanzi bezicelo zezempilo ze-Article 14(1)(a).Njengoba kuchazwe ku-Athikili 2(6) Yomthethonqubo (EC) No 1924/2006, "isimangalo sokunciphisa izifo" yinoma isiphi isimangalo sezempilo esishoyo, esincoma noma esisikisela ukusetshenziswa kwesigaba sokudla, ukudla noma enye yezingxenye zako.Kuncishiswe kakhulu izici eziyingozi zokuthuthukiswa kwezifo zabantu.Ngokusho kwe-Diet, Nutrition and Allergy (NDA) Panel ye-European Food Safety Authority (EFSA), iKhomishana ikholelwa ukuthi izimangalo zezempilo kufanele zibhekisele kubantu jikelele (abanempilo).IKomidi liphinde lacubungula ukuthi uma isimangalo sezempilo sihlobene nomsebenzi noma umphumela ongase uhlotshaniswe nesifo, izifundo ezinalesi sifo akuzona isibalo sabantu okuhloswe ngaso isimangalo (EFSA, 2021).
IKomidi belingayazi indlela eyasetshenziswa ekubuyekezweni kwezincwadi ezithunyelwe ngumfakisicelo ngakho-ke alikwazanga ukuhlola ukuthi ubufakazi buthunyelwe ukuze bucutshungulwe.Umfakisicelo uhlonze isamba sezincwadi eziyi-13 akholelwa ukuthi zihambisana nezimangalo, okuhlanganisa:
Ebufakazini obunikezwe Umfakisicelo, ama-RCT angu-2 (Lown et al. 2017; Thondre et al. 2021) awazange ahlole ubufakazi obusekela lesi simangalo.Isilingo esilawulwa ngokungahleliwe (u-Mudra et al., 2007) kwakuwumbiko ofinyeziwe futhi kwakubhekwa njengengozi enkulu yokuchema.Ucwaningo olungalawulwa (Chatterji and Fogel, 2018) aluzange luhlaziye ubufakazi bokusekela lesi simangalo.Izincwadi ezinhlanu (uBensky, 1993; Asano et al., 2001; Saudek et al., 2008; Gomyo et al., 2004; NIH, 2008) ayizange ibike imikhiqizo yokudla kanye/noma imiphumela efunwayo.Ukushicilelwa okuthathu (Lown, 2017; Drugs.com, 2022; Gordon-Seymour, 2021) kwakungewona ushicilelo olungelona olwesayensi.Okushicilelwe okukodwa (Thaipitakwong et al., 2018) kwakuyindatshana ebuyekeziwe emaqabunga kamalibhele kanye nomthelela wawo ongaba khona engcupheni ye-cardiometabolic.Ngokubona kweKomidi, azikho iziphetho ezingafinyelelwa kulezi zincwadi ukweseka lokhu kugomela.
Ngokusekelwe olwazini olunikeziwe, Ikomidi liphethe ngokuthi ubudlelwano obuyimbangela phakathi kokusetshenziswa kweqabunga le-M. alba kanye nemiphumela efunwayo abukwazanga ukusungulwa.Ikomidi liphinde laphetha ngokuthi abukho ubufakazi obuhlinzekiwe bokuhlangana phakathi kwemiphumela efunwayo kanye nengozi yokuba nesifo sikashukela sohlobo 2.
Isicelo besiqukethe isicelo sokuvikelwa kwedatha eyimfihlo, esahoxiswa kamuva.
Ukudla okwakuyisihloko sesimangalo sezempilo kwakungu-M. alba (umalibhele omhlophe), obalelwa ku-50% wezikelemu eziyindilinga.
Ukuba khona kukamalibhele kunciphise kakhulu inani le-glucose kusuka ezingeni lokulawula kuya ezingeni eliphansi futhi kwandisa kakhulu izinga le-insulin uma kuqhathaniswa nezinga lokulawula.Ocwaningweni lomtholampilo, izikelemu eziyindilinga zahlolelwa amandla azo okwehlisa amazinga eglucose.Ucwaningo lokungenela oluvulekile lwesikhungo esisodwa lwenziwa kwa-Israel.
Umfakisicelo uphakamisa amagama alandelayo esimangalo senzuzo yezempilo: "Kufakazelwe ngokomtholampilo ukusiza ukugcina amazinga kashukela egazini enempilo."
Umfakisicelo akazange aphakamise izimo ezithile zokusetshenziswa kokudla kwe-M. alba okuyisihloko sesimemezelo.Imigomo yokusetshenziswa ephakanyisiwe inikezwa isengezo se-Ascarit.Iqembu okuhlosiwe elihlosiwe yiziguli ezinesifo sikashukela sohlobo 2.
Ngokulandela Isigaba 14(1)(a) Somthethonqubo (EC) No 1924/2006 [umbhalo waphansi 1] Kushintshwe isimangalo somsoco (isichibiyelo) mayelana nezimangalo zezempilo zokukhishwa kweqabunga likamalibhele nokugcinwa kwamazinga kashukela egazi anempilo, njll. d.) (Ukwenqatshwa kwe-EU) Umthetho 2019 kanye Nemithethonqubo Yokudla (Izichibiyelo, njll.) (Ukushiya i-EU) I-ID yesicelo ye-Regulation 2020: 002UKNHCC.Yethulwe ngabakwa-Ascarit UK.
1.1 Ephendula isicelo se-UKNHCC sokucaciswa komkhiqizo wokudla okuyisihloko sesimangalo sezempilo, umfakisicelo uqinisekise ukuthi umkhiqizo wokudla uyisiqephu se-M. alba (iqabunga likamalibhele elimhlophe).Umfakisicelo akazange anikeze imininingwane ekuqanjweni, ukuhlukahluka kwe-batch-to-batch, noma izifundo zokuzinza ze-M. alba leaf extract.
1.2 Umfakisicelo unikeze isifinyezo senqubo yokukhiqiza i-Ascarite echazwa njengesengezo sezingxenye eziningi esiqukethe:
Amaqabunga nezimbali kuyahlanzwa futhi kucutshungulwe kabusha (okungukuthi, ukugcina umbala wazo wangempela, ukuma, nokuvuvukala) ngenhlanganisela yokusika, ukucindezela, nokukhipha ukushisa ngokuphisa ukuze kwandiswe ukutholakala kwemikhiqizo yezitshalo, kuhlanganise neshidi le-latex.Ngemuva kwalokho, uketshezi lupholiswa ngokushesha lube ngu-20-30 degrees Celsius, bese luhlungwa.Izingxenye zempande namagxolo ziyahlanzwa, bese zicutshungulwa kusetshenziswa ukususwa kokushisa nokupholisa.Isixazululo esixubile siqukethe (njengephesenti ngesisindo sengqikithi yesisindo sesixazululo) 50% Morus, 20% Artemisia, 10% Urtica, 10% Cinnamon kanye 10% Taraxacum.
Umfakisicelo ucele ukuthi kugcinwe uhlobo lobunikazi bokwakheka kwe-Ascarit kanye nenqubo yokukhiqiza, kodwa kamuva wayihoxisa le mfuneko.
1.3 Ngokombono weKomidi, ukukhishwa okunomsoco kwamaqabunga e-M. alba, okuyisihloko sesimangalo sezempilo, akuzange kuboniswe ngokwanele mayelana nemiphumela yesimangalo esihlongozwayo.
2.1 Umfakisicelo uthi isifo sikashukela sohlobo 2 yisifo esibonakala ngokukhuphuka kwamazinga kashukela egazini.Ephendula isicelo se-UKNHCC sobufakazi obubonisa ubuhlobo phakathi kwesici esiyingozi esibeka ingozi (i-glucose yegazi ephakeme) kanye nobungozi besifo esihlobene (uhlobo lwesifo sikashukela sohlobo lwe-2), umfakisicelo uhambise izifundo ze-3 (DCCT, 1995; Rohlfing et al., 2002 ; Sveta, 2014).Kokubili iqembu locwaningo lokulawulwa kwesifo sikashukela kanye ne-Complications Trial (DCCT) (1995) kanye noRolfing et al.(2002) kubika i-DCCTs kuhlanganise neziguli ezinesifo sikashukela esincike ku-insulin (uhlobo 1) kodwa hhayi nge-type 2 yesifo sikashukela.uhlobo (isifo okudingeka ukunciphisa ubungozi kuso).).U-Swetha (2014) ubala ukuhlobana phakathi kwe-HbA1c (i-glycosylated hemoglobin) kanye nemiphumela ehlukahlukene (ukuzila ukudla, i-postprandial kanye ne-glucose yokuphumula) ukuze kuhlolwe usizo lwazo ekuqaphelweni kokulawulwa kwe-glycemic ezigulini ezinesifo sikashukela.Ngokombono wekomiti, abafake izicelo abazange banikeze ubufakazi bobudlelwano obuyimbangela phakathi kwamazinga eglucose aphakeme kanye nobungozi bokuthola isifo sikashukela sohlobo 2, noma ukuthi amazinga kashukela egazi aphakeme ayisibikezelo esizimele sohlobo 2 lwesifo sikashukela.
2.2 Umfakisicelo unikeze ulwazi olwengeziwe ekuphenduleni isicelo se-UKNHCC solwazi ngomphumela, ukuguquguquka kwemiphumela kanye nokungenelela okuhlongozwayo kokuhlola izici zengozi ezifundweni zabantu.Kodwa-ke, ngokusekelwe olwazini olunikeziwe, iKomidi alilicaceli ukuthi yimiphi imiphumela abafake izicelo abayiphakamisayo nokuthi izohlolwa kanjani.
2.3 Umphumela ofunwa ngumfakisicelo “ufakazelwa ngokomtholampilo ukusiza ukugcina amazinga kashukela egazini enempilo”.Iqembu okuhloswe ngalo eliphakanyiswe ngumfakisicelo yiziguli ezinesifo sikashukela sohlobo 2.
2.4 IKomidi liphawula ukuthi iqembu elihlosiwe elihlosiwe leziguli ezinesifo sikashukela sohlobo 2 alikho ngaphansi kwezimangalo zezempilo ngaphansi kwe-Article 14(1) (a) ye-Regulation (EC) No 1924/2006.Njengoba kuchazwe ku-Athikili 2(6) Yomthethonqubo (EC) No 1924/2006, "isimangalo sokunciphisa izifo" yinoma isiphi isimangalo sezempilo esishoyo, esincoma noma esisikisela ukusetshenziswa kwesigaba sokudla, ukudla noma enye yezingxenye zako.Kuncishiswe kakhulu izici eziyingozi zokuthuthukiswa kwezifo zabantu.Ngokusho kwe-Diet, Nutrition and Allergy (NDA) Panel ye-European Food Safety Authority (EFSA), iKhomishana ikholelwa ukuthi izimangalo zezempilo kufanele zibhekisele kubantu jikelele (abanempilo).IKomidi liphinde lacubungula ukuthi uma isimangalo sezempilo sihlobene nomsebenzi noma umphumela ongase uhlotshaniswe nesifo, izifundo ezinalesi sifo akuzona isibalo sabantu okuhloswe ngaso isimangalo (EFSA, 2021).
2.5 Ukuze kuzuzwe umphumela ofunwayo, umfakisicelo uncoma ukuthi aphuze amaphilisi ama-roundworm ama-2 ngamanzi imizuzu engama-30 ngaphambi kokudla izikhathi ezi-3 ngosuku.Abafakizicelo abaphakamisi ukugxilisa ingqondo, umthamo noma ubude besikhathi sokusetshenziswa.
2.6 IKomidi liqaphele ukuthi ukuncipha kwempendulo ye-glycemic ye-postprandial kungase kubhekwe njengenzuzo kubantu asebevele benenkinga yokubekezelela i-glucose, kodwa iKomidi licabangele ukuthi amagama ahlongozwayo awahlangabezani nenqubo yokucatshangelwa ku-Article 14(1)(a) , futhi ayizange yenze izitatimende ngezinzuzo zezempilo Imibandela yabantu okungase kwenziwe ngayo izimangalo zokuncishiswa kwengozi yezifo.
3.1 Lapho becelwa i-UKNHCC, abafakizicelo bayacelwa ukuthi banikeze imininingwane yokubuyekezwa kwezincwadi, okuhlanganisa ubunikazi, izinjongo, indlela yokufaneleka, isu lokusesha eligcwele kanye nesizindalwazi ngasinye esiseshiwe.Ulwazi olwaluhlinzekiwe lwalulinganiselwe kangangokuthi iKomidi alikwazanga ukuhlola ukuthi ngabe bonke ubufakazi bulethiwe ukuze bucutshungulwe.
3.2 Umfakisicelo uhlonze isamba sezincwadi eziyi-13 akholelwa ukuthi zihambisana nezimangalo, okuhlanganisa:
IKomidi libheka ukuthi azikho iziphetho ezingafinyelelwa kulezi zincwadi njengoba abukho ubufakazi obuqinisekisiwe obusekela lesi simangalo.
3.4 Iqukethe isixhumanisi sencwadi yemithi yesintu yaseShayina (Bensky, 1993).Alukho ulwazi lwesahluko, izinombolo zamakhasi, noma izingcaphuno zale ncwadi ezihanjiswe ekomitini ukuze zicutshungulwe, ngakho azikwazanga ukuhlukaniswa.
3.5 Iphepha lamaqiniso (NIH, 2008) lifingqa izifundo zokulawula isifo sikashukela kanye nezinkinga kanye nezifundo zokulandelela, kodwa alihloli ubufakazi obusekela lesi simangalo, ngakho azikho iziphetho ezingathathwa kulokhu kushicilelwa.
Ucwaningo lwaselabhorethri (u-Asano et al., 2001) luchaze ukukhululwa kwe-M. alba alkaloid kanye nomphumela wawo ovimbelayo kuma-glycosidase, kodwa ubufakazi bokusekela lesi simangalo abukahlolwa.IKomidi libheka ukuthi azikho iziphetho ezingafinyelelwa kulezi zincwadi.
3.7 Kuma-RCT amathathu (Lown et al., 2017; Thondre et al., 2021; Mudra et al., 2007), ababambiqhaza babelwa ngokungahleliwe ukuze bathole ukukhishwa kweqabunga likamalibhele.Lown et al.(2017) kanye noThondre et al.(2021) bekuyizinyathelo ezingaboni kabili, ezingahleliwe, eziphindaphindwayo, izivivinyo ze-crossover ezihlola ukusetshenziswa noma ukungasebenzisi kweqabunga leqabunga likamalibhele (Reducose®) uma kuqhathaniswa ne-placebo ezifundweni ezinempilo izimpendulo ze-glycemic zabahlanganyeli enseleleni ye-carbohydrate.Ngokubona kweKomidi, azikho iziphetho ezingafinyelelwa kulezi zincwadi ngoba azizange zihlaziye ubufakazi obusekela lesi simangalo.U-Mudra et al.(2007) umbiko ofinyeziwe ofinyeza ucwaningo lwe-crossover olungahleliwe oluhlole umphumela wokukhishwa kweqabunga likamalibhele noma i-placebo ekuphenduleni kweglucose yegazi yabahlanganyeli abanempilo (abahlanganyeli abayi-10) kanye neziguli ezinesifo sikashukela sohlobo lwe-2 (abantu abayi-10).IKomidi libheke ukuthi ucwaningo lwalungase lube sengozini enkulu yokuchema ngenxa yokuntuleka kolwazi mayelana nenqubo ye-randomization, ukuchema okungenzeka okuhlotshaniswa nokungenelela okuhlosiwe, kanye nokuchema okungenzeka ekukhethweni kwemiphumela ebikiwe.
3.8 Ucwaningo olungalawulwa (Chatterji and Fogel, 2018) lwaluhlanganisa iziguli ezinesifo sikashukela sohlobo 2.I-Chatterji and Fogel (2018) ihlole umphumela wokwakheka kwekhambi i-SR2004 (okuhlanganisa amaqabunga e-M. alba, amaqabunga e-U. dioica, igxolo lesinamoni, okukhishwe kweqabunga le-A. dracunculus kanye nezimpande ze-T. officinale) kumazinga e-HbA1c kanye ngesonto izinsuku eziyi-12 .amasonto bese kuthi emavikini angama-24.Ngokombono weKomidi, azikho iziphetho ezingathathwa kulolu cwaningo olungalawulwa, olungazange luhlole ubufakazi obusekela izimangalo.
3.9 Ngakho-ke iKomidi libheka ukuthi azikho iziphetho ezingathathwa ebufakazini obethulwe ngummangali ngomphumela we-albaflora leaf extract ekugxilweni kweglucose yegazi.
4.1 Ekuhloleni ubufakazi, ikomidi licubungule isivivinyo esilawulwa ngokungahleliwe esingu-1 (Mudra et al., 2007) okungathathwa kuso iziphetho.
4.2 IKomidi liphethe ngokuthi, ngokusekelwe ebufakazini obethulwe, kwakungenakwenzeka ukusungula ubudlelwano obuyimbangela phakathi kokusetshenziswa kwe-Albiflora leaf extract kanye nemiphumela efunwayo.Ikomidi liphinde laphetha ngokuthi abukho ubufakazi obuhlinzekiwe bokuhlangana phakathi kwemiphumela efunwayo kanye nengozi yokuba nesifo sikashukela sohlobo 2.
I-Morus Alba (Muscus alba) Ingcaphuno Yeqabunga Isihloko sezicelo zezempilo ezihlongozwayo ayikacaciswanga ngokwanele maqondana nemithelela yezimangalo.
Izicelo zomphumela weziguli ezinesifo sikashukela sohlobo 2 azihlangabezani nenqubo ebekwe ku-Regulation (EC) No 1924/2006.ngokuhambisana neSigaba 14(1)(a).
Ubudlelwano obuyimbangela phakathi kokusetshenziswa kweqabunga likamalibhele kanye nemiphumela efunwayo abukwazanga ukusungulwa, futhi abukho ubufakazi bokuhlobana phakathi kwemiphumela efunwayo kanye nengozi yokuba nesifo sikashukela sohlobo 2.
Isikhathi sokuthumela: Jan-29-2023