Izithako zezitshalo ezinesisekelo sobufakazi obuqinile, obunezigaba eziningi azivamile esigabeni sokuphathwa kwesisindo. I-Theolim, isithako esithathwe ezitshalweni esizimele esakhiwe yi-NaturMed Scientific, sihlolwe ngokulandelana kocwaningo lwangaphambi kokwelashwa kanye nolwezokwelapha. Lesi sihloko sifingqa lokho okushiwo ubufakazi obushicilelwe njengamanje, lokho obungakubonisi, nokuthi kungani iphrofayili yokuphepha ibalulekile kubathengi.
Kuyini iTheolim?
I-Theolim iyinhlanganisela ejwayelekile, enelungelo lobunikazi yezingcezu ezimbili ezithathwe ezitshalweni: i-pend ye-Key lime (I-Citrus aurantifoliakanye nembewu yeCocoa (Ukhokho weTheobroma), kuhlanganiswe ngesilinganiso esingu-2:1. Zombili izinto ezisetshenziswayo ziwukudla okudliwa kakhulu okunomlando omude wokusetshenziswa kwabantu. Isithako esiqediwe silinganiswa amazinga aphansi e-citric acid (5.0%), i-theobromine (0.5%), kanye ne-hesperidin (0.3%), futhi sikhiqizwa esikhungweni esiqinisekisiwe se-Good Manufacturing Practice (Kundimi et al., 2024).
Ukwakheka kwakhethwa ngemuva kwenqubo yokuhlola ehlelekile lapho kwahlolwa khona izicucu zezitshalo ezingaphezu kuka-1,000. Ukuhlanganiswa kwezicucu ezimbili kwatholakala ukuthi kuveza imiphumela emikhulu kunezinye izithako ezihlukene, okuyisici esibizwa ngokuthi ukusebenzisana kwezemithi (Kundimi et al., 2024).
Isigaba 1: Ucwaningo Lwamaseli Nezilwane
Esifundweni sobufakazi bomqondo esanyatheliswa kuyi-Journal of the American Nutrition Association, uKundimi et al. (2024) baphenye i-Theolim emasikweni amaseli amafutha egundane kanye nasemodelini yezilwane yokukhuluphala okubangelwa ukudla. Emaseli amafutha, i-Theolim yabonwa isekela ukukhiqizwa kwe-fibroblast growth factor-21 (FGF-21), iphrotheni yokubonisa i-metabolic ehilelekile ekulawulweni kwamandla, kanye nokusekela ukubonakaliswa kwe-uncoupling protein-1 (UCP-1) kanye ne-beta-3 adrenergic receptor (β3-AR), womabili amaprotheni ahlotshaniswa nomsebenzi we-thermogenic ezicutshini zamafutha. Le miphumela yabonwa ngezinga elikhulu nge-extract ehlanganisiwe kunanoma yisiphi isithako kuphela (Kundimi et al., 2024).
Kumagundane aphiwe ukudla okunamafutha amaningi, ukwengeza ukudla ngomlomo izinsuku ezingu-28 kwakuhlotshaniswa nokwanda okuncike kumthamo wokusetshenziswa kwamandla okuphumula kanye nokwehla kokukhuluphala komzimba kanye nesisindo samafutha esiphelele uma kuqhathaniswa nezilwane ezingangeziwe. Ukudla akuhlukanga kakhulu phakathi kwamaqembu phakathi nalesi sikhathi (Kundimi et al., 2024). Njengakuzo zonke izicwaningo zezilwane, lokhu okutholakele akukwazi ukusetshenziswa ngqo emiphumeleni yabantu futhi kuqondakala kangcono njengobufakazi bokuqala bokusebenza.
Isigaba 2: Isivivinyo Esiphuthumayo Sokuwela Komuntu
Ucwaningo lokuqala lwabantu lwaluwucwaningo lwe-crossover oluhleliwe, olungaboni kabili, olulawulwa yi-placebo oluhilela abantu abadala abakhuluphele abangu-60 abaneminyaka engu-20 kuya ku-39 (i-BMI engu-25 kuya ku-29.9 kg/m²), olwanyatheliswa ku-Food & Nutrition Research (Ammatalli et al., 2024). Abahlanganyeli bathole i-capsule eyodwa engu-450 mg ye-Theolim noma i-placebo ehambisanayo, kanti izinga lokuphumula lomzimba (i-RMR) lalinganiswa kusetshenziswa i-calorimetry engaqondile emizuzwini engu-60, 120, kanye ne-180 ngemva komthamo, kanye nangesikhathi nangemva kweseshini yokuzivocavoca okulinganiselwe ngosuku olulandelayo.
I-RMR eqenjini le-Theolim yayiphezulu kakhulu ngokwezibalo kune-placebo ngesikhathi semizuzu eyi-120 kanye nemizuzu eyi-180. Ukushiswa kwamafutha, izinga umzimba osebenzisa ngalo amafutha njengomthombo kaphethiloli, kwabonakala futhi ukuthi liphezulu kakhulu eqenjini le-Theolim lapho liphumule kanye nasemaminithini angama-20 ngemva kokuzivocavoca, uma kuqhathaniswa ne-placebo (Ammatalli et al., 2024).
Umfutho wegazi kanye nesilinganiso senhliziyo akuzange kwehluke ngokuphawulekayo phakathi kwamaqembu kuzo zombili izimo, futhi wonke amanani ahlala ngaphakathi kwamazinga ajwayelekile okusebenza ngokomzimba kulo lonke. Abahlanganyeli eqenjini leTheolim nabo babhale amaphuzu aphansi kuhlu lwemibuzo lokuphazamiseka kwemizwelo oluqinisekisiwe ngesikhathi sokuzivocavoca uma kuqhathaniswa neqembu le-placebo (Ammatalli et al., 2024). Azikho izehlakalo ezimbi ezibikiwe. Abalobi baphawula ukuthi lolu kwakuwucwaningo lwesikhashana, nokuthi ucwaningo lwesikhathi eside luzodingeka ukuze kuhlolwe imiphumela eqhubekayo.
Isigaba 3: Isivivinyo Esilawulwayo Esingahleliwe Samasonto ayi-16
Ubufakazi obuqakathekile kakhulu babantu kuze kube manje buvela esivivinyweni esingahleliwe, esingaboni kabili, esilawulwa yi-placebo, esinamaqembu amaningi kubantu abadala abayi-120 abakhuluphele abaneminyaka engu-25 kuya kwengu-55, esanyatheliswa ku-Food & Nutrition Research (Chadalavada et al., 2025).
Abahlanganyeli bathole ama-450 mg/ngosuku lwe-Theolim noma i-placebo ehambisanayo amasonto ayi-16, balandela ukudla kwabo okuvamile, futhi bacelwa ukuba bahambe imizuzu engama-30 izinsuku ezinhlanu ngesonto. Ukudla kwamakhalori kwaqashwa kulo lonke futhi kwakungafani kakhulu phakathi kwamaqembu.
Isisindo somzimba kanye nokwakheka kwawo: Ngemva kwamasonto ayi-16, abantu abathatha i-Theolim bancipha isisindo esiningi ngokwesilinganiso (cishe ama-4.25 kg) kunalabo abathatha i-placebo (cishe i-1 kg). Babenokwehla okukhulu kwamafutha emzimbeni (cishe ama-4.28 kg uma kuqhathaniswa no-0.85 kg), futhi i-BMI yabo yehla kakhulu. Isisindo semisipha sahlala sifana kakhulu, ngokunyuka okuncane eqenjini le-Theolim kanye nokwehla okuncane eqenjini le-placebo (Chadalavada et al., 2025).
Ububanzi besinqe nesinqe: Umjikelezo wesinqe wehliswe ngesilinganiso esingu-4.32 cm eqenjini le-Theolim uma kuqhathaniswa no-2.10 cm ku-placebo, kanye nomjikelezo wesinqe ngo-3.16 cm uma kuqhathaniswa no-1.31 cm ngokulandelana, kokubili okubalulekile ngokwezibalo uma kuqhathaniswa ne-placebo esontweni le-16 (Chadalavada et al., 2025).
Izinga lokuphumula le-metabolic: Izinga lokuguqulwa kwe-metabolic lokuphumula likhuphuke kusukela ekuqaleni komthamo ngesilinganiso sama-kcal angu-459/ngosuku eqenjini le-Theolim ngesonto le-16, uma kuqhathaniswa cishe nama-kcal angu-102/ngosuku eqenjini le-placebo (p < 0.001 vs. placebo). Isilinganiso sokushintshana kokuphefumula naso sehlisiwe kakhulu eqenjini le-Theolim emavikini 8 no-16, okungase kuphakamise ukwanda okuhlobene kokusetshenziswa kwamafutha njengomthombo wamandla, yize incazelo yezokwelapha yalesi silinganiso ngokuhlukaniswa ilinganiselwe (Chadalavada et al., 2025).
Ama-Biomarker: I-Serum GLP-1, i-hormone ehilelekile ekulawulweni kwesifiso sokudla kanye nokusebenza kwe-metabolic, ikhuphuke cishe ngo-33% kusukela ekuqaleni eqenjini le-Theolim esontweni le-16 (p < 0.001 vs. baseline; p < 0.05 vs. placebo). I-Serum adiponectin ikhuphuke cishe ngo-52% kusukela ekuqaleni, kuyilapho i-ghrelin yehle kakhulu uma kuqhathaniswa nesisekelo kanye ne-placebo.
Iphrofayili ye-lipid kanye nokuzwela kwe-insulin: I-cholesterol ye-LDL, isilinganiso se-LDL/HDL, kanye ne-HOMA-IR, uphawu olusetshenziswa ukulinganisa ukumelana ne-insulin, konke kwehliswe kakhulu eqenjini le-Theolim ngesonto le-16 uma kuqhathaniswa ne-placebo (Chadalavada et al., 2025).
Ukubaluleka okubanzi kwezokwelapha kwalezi zinguquko ze-biomarker kumongo wesengezo sokudla kudinga uphenyo olwengeziwe oluzimele.
Azikho izehlakalo ezimbi kakhulu ezirekhodiwe. Izehlakalo ezincane ezifana nekhanda elibuhlungu, isicanucanu, nokukhwehlela zazifana phakathi kwamaqembu, futhi zonke izilinganiso ze-hematological kanye ne-biochemical zahlala ngaphakathi kwamazinga ajwayelekile kulo lonke (Chadalavada et al., 2025).
Ukuhlolwa Kokuphepha Kwangaphambi Kokwelashwa
Izifundo zokuphepha zangaphambi kokwelashwa ezenziwe ngaphansi kweziqondiso ze-OECD azitholanga bufakazi bokuthi kukhona ubuthi obukhulu noma umonakalo wezakhi zofuzo ohlotshaniswa ne-Theolim kumithamo evivinyiwe. Izifundo zezilwane ezisebenzisa umthamo ophezulu kanye nesikhathi eside azizange zibike imiphumela emibi noma ukukhubazeka okubalulekile ezimpawini zempilo, ukusebenza kwezitho zomzimba, noma isakhiwo sezicubu (Kundimi et al., 2023).
Umongo kanye nemikhawulo
Izivivinyo zemitholampilo zenziwa eNdiya futhi zaxhaswa ngokwengxenye embonini. Nakuba zibhalisiwe futhi zanyatheliswa emaphephandabeni abuyekezwe ontanga kulandela iziqondiso ze-Good Clinical Practice, ukuphindaphindwa okuzimele kwabantu baseYurophu kuzokwengeza ukuzethemba kokutholakele. Izivivinyo zibhalise abantu abadala abakhuluphele abane-BMI ephakathi kuka-25 no-29.9 kg/m², futhi imiphumela ingase ingasebenzi kubantu abangaphandle kwalolu hlu noma abanezimo zempilo ezibalulekile. Imiphumela yabonwa kanye nokudla okujwayelekile kanye nohlelo lokuhamba oluphansi (Chadalavada et al., 2025).
Qaphela: I-Theolim iyisithako sokudla esingeziwe, hhayi umkhiqizo wezokwelapha onelayisensi, futhi ayihloselwe ukuxilonga, ukwelapha, ukwelapha, noma ukuvimbela noma yisiphi isifo. Abathengi abanezinkinga zempilo ezikhona noma labo abathatha imithi bayelulekwa ukuthi babonisane nochwepheshe wezempilo ofanelekayo ngaphambi kokusebenzisa.
Okubhekwayo
U-Ammatalli, NKR, Kuricheti, SSSK, Veeramachaneni, S., Koo, YK, Ramanathan, G. no-Yalamanchi, A. (2024) 'Inhlanganisela ye I-Citrus aurantifolia i-fruit pend kanye Ukhokho weTheobroma Ukwengezwa kwezingcezu zembewu kuthuthukisa amazinga okusebenza komzimba kubantu abakhuluphele ngokweqile: ucwaningo olungahleliwe, olulawulwa yi-placebo, oluhlanganisa wonke umuntu, Ucwaningo Lokudla Nokudla Okunomsoco, 68, i-athikili 10745. Itholakala ku: https://doi.org/10.29219/fnr.v68.10745
I-Chadalavada, A., Koo, YK, Kim, S., Veeramachaneni, S., Ramanathan, G. kanye ne-Yalamanchi, A. (2025) 'A thermogenic botanical composition containing I-Citrus aurantifolia i-fruit pend kanye Ukhokho weTheobroma izingcezu zembewu zithuthukisa ukwakheka komzimba kubantu abadala abakhuluphele ngokweqile: uphenyo lwezokwelapha', Ucwaningo Lokudla Nokudla Okunomsoco, 69, i-athikili 12159. Itholakala ku: https://doi.org/10.29219/fnr.v69.12159
Kundimi, S., Chinta, G., Alluri, KV, Golakoti, T., Veeramachaneni, S., Ramanathan, G. kanye ne-Sengupta, K. (2023) 'Preclinical safety evaluation of LN19183: acute, subchronic, dermal, ocular and genotoxicity studies's's's's I-Vijayawada, India.
Kundimi, S., Chinta, G., Alluri, KV, Golakoti, T., Veeramachaneni, S., Ramanathan, G. kanye noSengupta, K. (2024) 'Ukwakheka kwezitshalo okuhambisanayo kwandisa ukusetshenziswa kwamandla okuphumula futhi kunciphisa ukukhuluphala kwamagundane adla ukudla okunamafutha amaningi', Ijenali ye-American Nutrition Association, 43(3), amakhasi 286–295. Itholakala ku: https://doi.org/10.1080/27697061.2023.2280777
Disclaimer: Lesi Sitatimende asikahlolwa yi-EFSA, i-KFDA noma i-FDA. Lo mkhiqizo awuhloselwe ukuxilonga, ukwelapha, ukwelapha, noma ukuvimbela noma yisiphi isifo. Nakuba ulwazi olunikeziwe lusekelwe ezinkombeni ezithembekile, asenzi noma yiziphi izimangalo noma iziqinisekiso ezithile. Kubalulekile ukubonisana nomeluleki wakho wezempilo ukuze uthole iseluleko nesiqondiso esiqondene nawe esiphathelene nempilo yakho.
