Hiu qu v s dung np ca cng thc tho dc trong kim sot cn nng

TM TT

Cc hiu qu lm sng v kh nng dung np ca mt cng thc tho dc bao gm chit xut ca Sphaeranthus indicus v Garcinia mangostana c nh gi trong hai thit k nghin cu ngu nhin, m i, i chng gi dc tng t nhau. Cc th nghim lm sng trn 100 i tng con ngi c ch s khi c th (BMI) t 30 n 40 kg / m2. Nhng ngi tham gia c chn ngu nhin thnh hai nhm nhn 400 mg hn hp tho dc, 2 ln/ngy hoc 2 vin gi dc. Tt c cc i tng c nhn 3 ba n (2000 kcal / ngy) trong sut nghin cu v i b 5 ngy/ tun trong 30 pht. Kt qu chnh l gim trng lng c th. Kt qu ph l gim BMI, vng eo v hng. Glucose trong huyt thanh, lipid, v mc adiponectin cng c o lng. 95 i tng hon thnh cc cuc th nghim, v d liu t hai nghin cu ny c gp chung v phn tch. Kt lun nghin cu (sau 8 tun), c s gim ng k v mt thng k trng lng c th (5.2 kg; P

Vi mc tiu pht trin mt sn phm gim cn mnh nhng an ton t thnh phn c ngun gc tho dc, chng ti kim tra mt th vin cc chit xut t cy thuc khc nhau c tc dng chng adipogenic v c hot tnh lipolytic. Sng lc adipogenic c nh gi s khc bit t bo m tr (preadipocyte) n t bo m trng thnh (mature adipocyte) invitro trn chut 3T3-L1

Sng lc lipolysis c thc hin vi cc t bo m trng thnh 3T3-L1 bng cch gim st s tit sn phm ph lipotic - glycerol vo mi trng nui cy. Mt hn hp pha trn chit xut ca hoa Sphaeranthus indicus v qu Garcinia mangostana c chng minh l c hiu qu trong vic c ch adipogenesis (s to m) ng thi thc y lipolysis (phn gii m) (cha cng b d liu).

y, chng ti bo co cc kt qu ca mt phn tch gp kt hp d liu t hai nghin cu ngu nhin, m i, i chng vi placebo nh gi hiu qu v kh nng dung np ca hn hp tho dc cp trc kim sot trng lng c th trong cc i tng bo ph vi kt qu chnh l gim cn.

VT LIU V PHNG PHP

Vt liu nghin cu

Hn hp tho dc bao gm cc cht chit xut t dung dch cn hoa S. indicus v qu G. mangostana. Cc cht chit xut c tp trung v pha trn vi nhau trong mt t l 3: 1 ca dch chit S. indicus v G. mangostana t c mt sn phm cui cng c cha 3% 7-hydroxyfrullanolide v 2% a-mangostin. 2 marker phytochemical c la chn da trn xt nghim sinh hc v p ng tiu chun cht tham chiu ni sinh kim sot tnh nht qun gia cc l m. Tt c cc l c th nghim cho hot tnh sinh hc nh mt yu t m bo cht lng.

Hn hp tho dc c phn tch vi Acquity UPLC H-Class (Waters Corp, Milford, MA, USA) reversed phase ultra performance liquid chromatography (UPLC) vi Phenomenex Kinetex 1,7 lm, 100 mm C18 2.1 mm Column (Torrence, CA, USA) duy tr 40oC. Mt s mu tham kho v cc mu c chun b trong acetonitrile. tuyn tnh c chng minh bi mt hiu chun 3 im theo mu i chiu. Cc mu c chun b nng theo mu i chiu cc cp. Cc dung dch mu sau c siu m v lc qua b lc polytetrafluoroethylene vo 1 vial t ng. Cc mu c phn tch di mt gradient ra gii vi mt ng chun gradient t 30% n 70% acetonitrile trong 0,1% axit photphoric cho 7 pht mt tc dng chy 0,6 ml / pht v 210 nm. Cc ct c cn bng cho thm 2.5 pht trc mi ln chy (Hnh. 1).

Hn hp tho dc (400 mg) c ng gi trong vin nang gelatin cng c 0 vi cc t dc. Vin nang Placebo ch cha t dc, v ging ht nhau v hnh dng, kch thc, trng lng v mu sc cho cc vin nang hot ng. Cc tho dc hn hp c cung cp bi InterHealth Nutraceuticals, Inc (Benicia, CA, USA) theo mt tha thun cp php vi Laila Nutraceuticals, (Vijayawada, n ).

Tuyn dng ca cc i tng

Hai th nghim lm sng c thc hin Alluri Sitarama Raju Hc vin Khoa hc Y t (ASRAM), Eluru, Andhra Pradesh, n t thng 11 nm 2009 n thng 4 nm 2010

(S ng k dng th: ISRCTN45078827) v t thng 3 nm 2010 n thng 7 nm 2010 (ng k th nghim lm sng s: ISRCTN52261953). Cc giao thc nghin cu c nh gi v ph duyt bi cc ASRAM Institutional Review Board (IRB).

Mt bn tm tt ca thit k nghin cu lm sng c cung cp trong Hnh 2. Tng cng c 182 i tng tham gia trong vic la chn, qu trnh t chc ti S Internal Medicine ca Bnh vin ASRAM bi mt th tc sng lc da trn bng cu hi.

Trong s 182 ng vin c sng lc, 100 i tng ngi t cc tiu ch c a vo nghin cu (Bng 1). Mi ngi tham gia t nguyn k IRB ph duyt mu chp thun thng bo. Sau khi tuyn chn, cc i tng c phn ngu nhin vo mt trong hai hoc gi dc hoc nhm s dng tho dc.

Thit k nghin cu

Mc ch ca 2 thit k th nghim lm sng ngu nhin, m i, i chng gi dc l nh gi cc hiu qu gim cn ca hn hp tho dc cc i tng bo ph. Cc kt qu ca nghin cu l gim trng lng c th.

Ti nh gi c bn (baseline), tt c cc i tng c cung cp vin nang hot ng hoc gi dc, th tun th, danh sch cc hng dn tp th dc, lch trnh cho giao cc ba n hng ngy, v ngy theo di nh gi. Vic min ph ba n c chun b (2000 kcal / ngy) c cung cp trong ba phn: ba sng, ba tra v ba ti vi 61% t carbohydrate, 14% t protein, v 25% t cht bo. Cc i tng c hng dn ung hai vin mt ngy, mi 30 pht trc ba n sng v ba ti.

Tt c cc i tng hon thnh mt bng cu hi lin quan n tin s v vic s dng thuc, tun th ch tp luyn th dc, ch n ung ti c s, cng nh tt c cc nh gi theo di 14, 28 v 56 ngy. Ngoi ra, tt c cc i tng hon thnh mt phin bn 27-mc ca cc tc ng ca trng lng trn cht lng cuc sng (IWQOL) cu hi ngy 0 v 56. Vo ngy 0 (baseline) v cc ln theo di sau theo di, i tng c nh gi trng lng c th, chiu cao, vng eo, hng, v cc du hiu quan trng. Mu v nc tiu c thu thp, tt c cc nh gi v phn tch nh m t bn.

nh gi v huyt hc v sinh ha

Hot ng chuyn ha v lipid c nh gi trong huyt thanh, trong khi vic th mu c thc hin trong mi ln khm. Cc thng s sinh ha huyt thanh v huyt hc c o bng my phn tch t ng HumaStar 300 (HUMAN Diagnostics, Wiesbaden, c) v Humacount (HUMAN Diagnostics). Cc phn tch nc tiu c thc hin bi UroColor10 Dip Sticks v Urometer-600 (Standard Diagnostics, Kyonggi-do, Hn Quc) v soi knh hin vi nc tiu.

Bng 1. Tiu chun la chn v Tiu chun loi tr

Tiu chun thu nhn

i tng nn hiu nhng ri ro v li ch ca nghin cu

Ngi ln: 21 50 tui

BMI t 30 n 40 kg / m2

Sn sng tham gia vo cc chng trnh tp th dc i b, s gim st ca mt chuyn gia tp th dc o to

Sn sng nghin cu (ba n cung cp min ph bi nghin cu nh ti tr)

Vn bn ng tham gia vo th nghim

Sn sng hon thnh lch s cu hi sc khe tiu chun trc khi tuyn dng vo nghin cu

Sn sng tham gia trong nm ln kim tra lm sng (sng lc, c bn, 2, 4 v 8 tun)

i tng nn trnh cc sn phm c cn trong thi gian nghin cu

Nu n: khng mang thai, cn phi s dng bin php trnh thai trong thi gian nghin cu

Tiu chun loi tr

Lch s ca bnh tuyn gip, bnh tim mch, tiu ng hay tin s d ng vi cc thnh phn tho dc trong sn phm

Trng lng c th c BMI> 40

Khng bo ph (BMI

c im nhn khu hc

Hn hp tho dc c phn tch bi HPLC, v cc nh chnh c xc nh trong Hnh 1. 7-hydroxyfrullanolide c tch ra 2,5 pht, v a-mangostin c ra gii 5,9 pht.

c im nhn khu hc v c s nghin cu ca i tng c tm tt trong Bng 2, bao gm tui, gii tnh, chiu cao, cn nng, BMI, vng eo, hng, huyt p v nhp tim tng t gia nhm dng tho dc (800 mg / ngy, n = 49) v gi dc (n = 46) nhm.

Gim trng lng c th v BMI

Hnh 3A tm tt nhng thay i trng lng c th trong thi gian cho i tng s dng nhm tho dc hoc gi dc. Nhm s dng tho dc c s gim r rt trng lng c th ca h vo tun 2, 4 v 8 so vi nhm gi dc c ngha thng k (P

ca 1.3, 2,3 v 3,8 kg lc 2, 4 v 8 tun, tng ng vi 1,6%, 2,8%, 4,6% trng lng c th. Mt s gim tng t trong BMI c quan st thy cc i tng tiu th cc hn hp tho dc (Hnh 3B v Bng 3). B sung hn hp tho dc mang li mt 1 s gim ng k ch s BMI 0.5, 0.9, v 1.6 kg / m2 (P

Mc adiponectin huyt thanh

Hnh 4 minh ha rng s dng tho dc trong 8 tun dn n mt s gia tng ng k 22,5% mc adiponectin (P = 0,0008) so vi gi dc. Nhng kt qu ny cho rng tho dc c th nh hng n chuyn ha lipid.

Nhng thay i trong chuyn ha lipid mu v ng huyt lc i

Kt qu phn tch cc cht trong mu ban u v h s c nhn cc i tng ny ch ra rng mt t l ln nhng ngi tham gia th nghim trong c hai nhm ngi c mt cao lipoprotein, triglycerid, mc glucose lc i cao, v kch thc vng eo ln. iu ng ch l nhm dng tho dc gim ng k tng s cholesterol v triglyceride vi mc 13,8% (P = 0,002) v 41,6% (P

(P

c suy ra rng cc bin ECG khng lin quan n vic s dng tho dc. Nhn chung, s dng tho dc khng gy nh hng n chc nng tim.

Rt lui khi nghin cu

5 i tng (mt t nhm tho dc v bn t

nhm gi dc) rt lui khi nghien cu (Hnh. 2). Khng c i tng no ngng tham gia nghin cu do tc dng ph. Cc kt qu do i tng rt lui khi nghin cu c loi tr khi tt c thng k phn tch theo cc tiu ch c xc nh trc trong thit k nghin cu.

THO LUN

Mc tiu ca phn tch hin ti l nh gi hiu qu v dung np ca mt hn hp tho dc trong vic thc y gim cn lnh mnh. Chng ti kt hp cc d liu t hai nghin cu lm sng ngu nhin,m i, c i chng vi placebo tin hnh 100 i tng con ngi c ch s BMI t 30 v 40 kg / m2 t c mc thng k cao hn, qua cung cp mt ci nhn su sc rng ln hn vo cc tc ng c li ca s pha trn tho dc trong vic kim sot trng lng.

Nhng pht hin chnh ca hai nghin cu ny chng thc trc kt qu l s pha trn tho dc, kt hp vi mt ch n ung tiu chun (2000 kcal / ngy) v tp th dc hng ngy va phi, dn n mt s gim trng lng c th, vng eo v hng ng k so vi kim sot ch n ung v tp th dc. Theo bo co trc , li ch b sung tho dc l lm gim trng lng trung bnh 3,8 kg so vi gim trng lng trung bnh 1,5 kg nhm gi dc. Chng ti cng quan st thy rng s gim cn do tho dc sau 2

tun s dng l c ngha thng k, bao gm gim vng eo v hng. Mc d nghin cu khng th o lng nhng thay i trong thnh phn c th nhng s gim c ngha thng k t l eo: hng (waist hip ratio/WHR) c quan st thy trong nghin cu (P

hp tho dc khi kt hp vi thay i li sng c th iu chnh mt s con ng quan trng lin quan n qu trnh chuyn ha cht bo v glucose.

N cng xc lp rng bo ph nh hng xu n sc khe, cm xc hnh phc, v chc nng tm l. Ph hp vi nhng pht hin ny, thng s cht lng cuc sng c ci thin ng k hn cho cc i tng b sung tho dc. i tng bo ph, ngi tri qua phu thut gim bo cng thy s ci thin r rt cht lng sc khe.

Hn hp tho dc c dung np tt c hai th nghim lm sng. Khng c tc dng ph nghim trng c bo co t vic s dng cc hn hp tho dc. Ch c mt vi tc dng ph nh c bo co mt s ngi tham gia, c phn b u gia gi dc v nhm tho dc. Khng c thay i trong marker sinh hc trong mu lin quan n gan, thn, v chc nng tim, cng khng c bt k thay i trong du hiu sinh tn. Hn na, chng ti khng pht hin bt k bt thng no trong ECG do b sung tho dc.

Tm li, b sung hn hp tho dc vi liu hng ngy 800 mg dn n gim ng k v mt thng k trng lng c th, BMI, vng eo v hng so vi ch n ung v tp th dc mt mnh. nh hng ng k ca tho dc trn trng lng c th v cc thng s khc xy ra sm nht l 2 tun sau khi s dng. S dng hn hp tho dc cng lm ci thin ng k thnh phn lipid mu v kim sot ng huyt . nh gi cc thng s an ton khc nhau lin quan n gan, thn v chc nng tim, cng vi khng c tc dng ph c ngha trong qu trnh nghin cu di 8 tun ch ra rng hn hp tho dc c dung np tt. T cc nghin cum t y l mt thi gian tng i ngn, cc th nghim di hn hn l cn thit xc nh hiu qu ca hn hp tho dc v tnh an ton khi s dng trong thi gian di. Kt qu t 2 nghin cu ny cho thy hn hp tho dc l mt thnh phn c hiu qu v dung np tt trong kim sot gim cn.