Oral herbal supplement containing magnesium sulfate improve

 
 
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                                                                                         nal Articlee
                                                                                    http://m
                                                                                           mjiri.iums.ac.irr

                                                                                    Med J Isllam Repub Iran. 2019(6
                                                                                                             2      Feb);33.2
                                                                                                                            2. https://doi.org/110.34171/mjiri.33
                                                                                                                                                                3.2
[ DOI: 10.34171/mjiri.33.2 ]




                                                                           Oral herrbal suppplement containing magn    nesium sulfate
                                                                           improvee metabo  olic contrrol and in
                                                                                                               nsulin re
                                                                                                                       esistance
                                                                                                                               e in
                                                                           non-diabbetic oveerweightt patients: A rand domized
                                                                           double bblind clin
                                                                                            nical triall
                                                                           Mehrdad Solaati1, Leila Kazeemi1, Naghi Sh
                                                                                                                    hahabi Majd2, Mansoor Kesshavarz3, Nima Pouladian4, Nepton Solta
                                                                                                                                                                                   ani*5

                                                                               Received: 12 M
                                                                                            Mar 2017                             Published: 6 Feb 22019

                                                                           Abstract
                                                                              Background   d: Magnesium deficiency
                                                                                                             d           play
                                                                                                                            ys a key role in obesity and deecreases insulin sensitivity. In our previous sttudy, significannt
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                                                                           evidence was pprovided for the contribution of oral Mg suppplement that could   c      improve insulin
                                                                                                                                                                            i       sensitivi
                                                                                                                                                                                           vity and body weight
                                                                                                                                                                                                           w       in animaal
                                                                           trials. The purppose of the present study was to t investigate thhe effects of an herbal supplemment containingg 300 mg magneesium sulfate onn
                                                                           lipid profile, ass well as insulinn resistance and
                                                                                                                            d secretion in ovverweight patieents.
                                                                              Methods: Seeventy overweiight non-diabettic volunteers w      with Body Masss Index (BMI)) >28 kg/m2 w        were included in a randomizedd
                                                                           double blind pllacebo-controlled clinical triall (ethic numberr HUMS REC.1       1394.57) and reegistered in Irannian Registry of Clinical Trialls
                                                                           (IRCT20121100124756N2 withh registration number  n        24756).. They received d either placeboo or an herbal ssupplement cap psule containingg
                                                                           300 mg magneesium sulfate (M     MgSO4) for 6 months
                                                                                                                            m       on a daiily basis. Metabbolic control, lipid profile andd magnesium staatus were deterr-
                                                                           mined at baseliine and every thhree months. Sttudent t-test, reppeated measuree ANOVA and ANCOVA  A           werre used to comppare the groups.
                                                                             Results: Theere was no signiificant differencce between grouups before interrvention, but daaily Mg supplem    ment for 6 months significantlyy
                                                                           improved fastiing insulin levvel (6.71±0.11 to 6.27±0.3 th       three months after
                                                                                                                                                            a     Mg therapy, p
Herbal magnnesium sulfate supplement improves insuulin resistance

                                                                          mellitus (NID DDM) patientts (2). The prrevalence of oover-                                Methods
                                                                                                                                                                     M
                                                                          weight betweeen urban population aged above  a      18 yearr and                            Th
                                                                                                                                                                       his study wass a randomizzed, double-blind, placeboo-
                                                                          under age 188 year is rouughly estimatted at 21.7%        % and                          conttrolled trial confirmed
                                                                                                                                                                                     c            byy the ethics committee of   o
                                                                          6.1%, respecttively (3).
[ DOI: 10.34171/mjiri.33.2 ]




                                                                                                                                                                   Horm mozgan univeersity of mediical sciences (ethic numbeer
                                                                             The influennce of body fatf distribution n on insulin ssensi-                         HUM MS REC.1394   4.5 7) and reegistered in Iraanian Registryy
                                                                          tivity has beeen a question ofo great intereest in the literrature                       of Clinical
                                                                                                                                                                       C       Trials (IRCT20121 10124756N2 with registraa-
                                                                          due to the higgher risk of caardiovascular illness and tyype 2                           tion number 247   756). Data pprivacy and confidentiality
                                                                                                                                                                                                                   c             y
                                                                          diabetes in ppatients, but thhe exact med   diators remainn un-                          weree protected acccordingly. Alll participantss and researchh-
                                                                          clear. Magneesium deficienncy is said to     o play a rolee (4),                         ers except for twwo, with randdomized particcipation, weree
                                                                          since it often coincides wiith insulin resistance in diaabetic                           blindd to the study protocol. O Our colleaguee who was ree-
                                                                          patients (4). G
                                                                                        Guerrero-Rom  mero et al showwed that a 3-m  month                         sponnsible for sam
                                                                                                                                                                                    mple randomizzation allocated the particii-
                                                                          MgCl2 (2.5 g daily) therapyy could enhan   nce beta cells’ abil-                         pantt between gro oups by usingg table of ran ndom numberrs
                                                                          ity to set offf insulin senssitivity in non n-diabetic pattients                         and replacement sample in casse if we lost someone. Thee
                                                                          with considerrable hypomaagnesaemia (4     4). Some reseaarch-                           research flows illu
                                                                                                                                                                                     ustration is prresented in Fig
                                                                                                                                                                                                                  g. 1.
                                                                          ers (4-6) havee provided im mportant data indicating
                                                                                                                      i           thatt oral
                                                                          Mg supplemeent improves insulin
                                                                                                        i       sensitiivity even in oover-                           Paarticipants
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                                                                          weight, non--diabetic and normal mag         gnesium subjjects.                             In
                                                                                                                                                                       n this study, based on Iraanian insulin resistance bii-
                                                                          They emphassize that earlyy optimization    n of Mg is n eces-                           omaarker and the biostatistician
                                                                                                                                                                                      b               suggestion, th
                                                                                                                                                                                                                   he sample sizee
                                                                          sary to prevennt insulin resistance and typ pe 2 diabetes. Kim                           was determined using
                                                                                                                                                                                     u      the followwing formulaa:
                                                                          et al. showed an opposite reelationship beetween magneesium                                 n== 2SD (zα/2+Zβ) 2/ d2 (zα/22=1.96, Zβ=0.84)
                                                                          ingestion andd diabetes in American
                                                                                                        A          neww generation. This                              Thhe inclusion criteria for the overweig    ght volunteerrs
                                                                          may be due too the reverse correlation
                                                                                                       c            of magnesium inntake                           weree age (19–69 years), Bodyy Mass Index      x (>28 kg/m2)
                                                                          with systemicc inflammationn and insulin resistance (7) .                                (14)), adequate carrdiovascular aand gastrointestinal functionn
                                                                             In our prevvious study, we
                                                                                                      w reported thaat oral magneesium                             and appropriate mobility
                                                                                                                                                                                      m          as wwell as being
                                                                                                                                                                                                                 g non-diabeticc,
                                                                          sulfate adminnistration in annimal diabeticc model couldd not                            non--pregnant, no  ormotensive and with no      o dietary ree-
                                                                          increase insullin secretion, but
                                                                                                        b could improve insulin ssensi-                            stricctions (our paatients followwed the usuall diet, but wee
                                                                          tivity by an increase in Glucose transporter numbber 4                                   askeed them to co  omplete the 224 hours foo   od recall formm
                                                                          (GLIUT4) geene expressioons (8). It could  c        also coorrect                        whicch we prepareed for them) oor allergies with
                                                                                                                                                                                                                 w no historyy
                                                                          blood glucosse and lipid profile,
                                                                                                        p        and lessen
                                                                                                                       l       high bblood                         of food
                                                                                                                                                                       fo allergy or sensitivity tto magnesium   m supplementss.
                                                                          pressure and diabetic vasccular complications (9-12) . We                                Patieents who had known kidneey diseases (seerum creatininn
                                                                          also found thaat daily adminnistration of 300 mg magneesium                              abov ve 1.3 mg/dl in women annd higher than    n 1.5 mg/dl inn
                                                                          sulfate for 3 months in tyype 2 diabeticc patients, siggnifi-                            men n), raised hepaatic enzymes ((above 3 fold ds over normaal
                                                                          cantly improvved fasting blood sugar, 2-hour post praandial                              rang ge), current in
                                                                                                                                                                                      nfections (few wer one mon  nth during thee
                                                                          glucose, lipidd profile, bloodd pressure, and hepatic enzyymes                           studdy) and chronic inflammatorry diseases, ceerebrovasculaar
                                                                          (13). In this study howevver, due to prrevalence of oover-                               accident (CVA) anda acute coroonary syndrom    me (ACS) less
                                                                          weight amongg Iranian population, we used an herbal sup-                                 thann a month duriing the study, but alcoholicss or drug userrs
                                                                          plement conttaining MgSO    O4 in the non-diabetic obe se to                             weree omitted. Moreover,
                                                                                                                                                                                    M            patiients with inssulin, calcium
                                                                                                                                                                                                                                m
                                                                          measure the eefficacy of thee drug on insulin resistance..                               chan nnel blockers and Mg suppl  plements were also excludedd
                                                                                                                                                                   fromm the study. After
                                                                                                                                                                                      A      an openning screening g and face-offf
                                                                                                                         1000 reeviewed medical documents
                                                                                                                                                d



                                                                               28 not agreeed to take part           200 docum
                                                                                                                             ments suitable for the
                                                                                                                                                t study                 90 not respondin
                                                                                                                                                                                       ng the Phone



                                                                                                                    82 came to office
                                                                                                                               o      for primary evaluation



                                                                                                                   76 had clinicaal & laboratory sttudy criteria



                                                                                                                                 76 randomized

                                                                           3 lost to follow up:
                                                                                                                                                                        3 lost to follow up:
                                                                                                                                                                                         u
                                                                           3 moved from th
                                                                                         he city                   38 Placebo grroup          38 Mg
                                                                                                                                                 M group
                                                                                                                                                                        1 Getting pregnaant
                                                                                                                                                                        2 moved from thhe city

                                                                                                             35 Completed                 35 Comppleted
                                                                                                             6 months
                                                                                                               m      interventio
                                                                                                                                on        6 monthss intervention
                                                                          Fig.
                                                                          F 1. Study folloow diagram

                                                                                  http://m
                                                                                         mjiri.iums.ac.ir
                                                                           2      Med J Isslam Repub Iraan. 2019 (6 Feb)); 33:2.
M.
                                                                                                                                                                                                                           M Solati, et all.

                                                                          period, particcipants were randomly cho      osen and enrrolled                         Thhe possible ch hanges betweeen case and control groupp
                                                                          for the study protocol upoon taking informed written con-                            befoore intervention were anaalyzed by Sttudent's t-testt.
                                                                          sent to get eiither herbal supplement
                                                                                                       s             caapsules contaiining                     Com mparisons betw ween groups aand the possibble differences
[ DOI: 10.34171/mjiri.33.2 ]




                                                                          300 mg MgS    SO4 or placebbo (wheat braan) every morrning                           betwween means off each group dduring the inteervention weree
                                                                          for 6 monthss (Fig. 1). Sixx participants did not com    mplete                      cond ducted with reepeated measuure of ANOVA  A and analysis
                                                                          the whole stuudy while otheer participantss followed thee usu-                       of covariance
                                                                                                                                                                   c           (ANCOVA). Foor the analysees, SPSS softt-
                                                                          al diet and phhysical activityy during the coourse of studyy.                        waree, version 13, was used andd P
Herbal magnnesium sulfate supplement improves insuulin resistance

                                                                            Table 2. Studyy variables in Mgg treated and placcebo groups 3 moonths (M3) and 6 months (M6) affter intervention aand comparisonss between
                                                                            groups were annalyzed using thee repeated measurre and ANCOVA   A (data are expressed as mean± SEM)
                                                                                                                    Placebo group
                                                                                                                             g                                         Mg-trea
                                                                                                                                                                             ated group
                                                                                                    M0                    M3                   M6                    M0                  M3                  M6
                                                                                                                                                                                                             M
[ DOI: 10.34171/mjiri.33.2 ]




                                                                            Sex (F/M)              15/20                 15/20
                                                                                                                             0                15/20                 16/19               16/19               16//19
                                                                            BMI                28.92±0.19             28.92±00.19         28..92±0.19            28.81±0.15         28.81±0.1 5         28.81± ±0.15
                                                                            TG                165.37±7.46            159.21±6.92          1633.17±6.1           163.22±7.67         159.11±6.667        141.2±±5.84$
                                                                            Cholesterol       140.02±4.59             142.82±±4.3         1399.45±5.28            143.2±5.8         137.65±5..1        131.34 4±4.27
                                                                            LDL               115.48±3.94            116.48±3.69          1122.62±3.41          117.11±3.01         110.62±3.008       104.42±2.35$
                                                                            HDL                 44.4±0.81             44.34±00.91         43..57±0.82            43.28±1.09         43.91±1.922*          46±00.88#
                                                                            HDL/TG              0.28±0.01             0.29±0.01            0.227±0.01             0.28±0.01          0.29±0.011              ±0.01*
                                                                                                                                                                                                         0.34±
                                                                            Insulin             6.67±0.76             6.71±0.11            6.441±0.11             6.66±0.08          6.27±0.1##              ±0.06*
                                                                                                                                                                                                         5.83±
                                                                            HOMA-IR              1.5±0.03             1.52±0.03            1.337±0.05             1.49±0.02          1.36±0.033$             ±0.02$
                                                                                                                                                                                                         1.22±
                                                                            FBS                 91.54±1.5             91.85±11.58          855.53±3.1            90.68±1.43         88.34±1.551         84.85± ±1.48
                                                                            Mg                  1.93±0.02             1.97±0.02            1.993±0.02             1.98±0.03          2.02±0.022              ±0.02*
                                                                                                                                                                                                         2.12±
                                                                            Abbreviation: Boody mass index (BMMI), Fasting blood glucose
                                                                                                                                 g       (FBG) , Loow density lipoproteein cholesterol (LDL
                                                                                                                                                                                          L) , High density lippoprotein cholestero
                                                                                                                                                                                                                                  ol (HDL),
                                                                            triglyceride (TG)) , magnesium (Mg)), and HOMA–IR = FBG (mg/dl) × FPPI (µu/ml) ∕ 405).
                                                                            * Mg-treated-M33 vs Placebo-M3 annd Mg-treated-M6 vsv Placebo-M6 (p
M.
                                                                                                                                                                                                                   M Solati, et all.

                                                                          and it could bbe of great help
                                                                                                      h     for non-d
                                                                                                                    diabetic insuliin re-                   an
                                                                                                                                                             nd treatment of ov  verweight and obeesity in adults. 19
                                                                                                                                                                                                                    998.
                                                                                                                                                          16. Kurtolu
                                                                                                                                                               K          S, Hatip
                                                                                                                                                                                 polu N, Mazcollu M, Kendirci M, Keskin M,          M
                                                                          sistance patieents. The Mg deficiency plays
                                                                                                                    p     an impoortant                     Ko ondolot M. Insullin Resistance in Obese Children and Adolescentss:
                                                                          role in insulinn resistance annd increased risk
                                                                                                                     r for type 2 dia-                      HO OMA-IR Cut-Offf Levels in the PPrepubertal and Pubertal
                                                                                                                                                                                                                    P        Periods. J
[ DOI: 10.34171/mjiri.33.2 ]




                                                                                                                    M therapy is sug-
                                                                          betes and fattty liver in addults; hence Mg                                       Cllin Res Ped Endo. 2010;2(3):100-1106.
                                                                          gested as a loow-cost, easyy to use and natural
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                                                                                                                                                               M         FC, Krügger K, Völker k, Golf SW, Wadepuhl M, Kraus A.      A
                                                                                                                                                            Orral magnesium supplementation rreduces insulin resistance
                                                                                                                                                                                                                    r           in nonn-
                                                                          for preventionn of type 2 diaabetes.                                              diabetic subjects – a double-blindd, placebo-contro     olled, randomized
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                                                                            Acknowled
                                                                                    dgments                                                               18. Hadjistavri
                                                                                                                                                               H             LS, Sarafidis
                                                                                                                                                                                 S         PA, Geeorgianos PI, Tziiolas IM, Aroditiis
                                                                            This study was supportted by Deputty of Researcch of                            CP P, Hitoglou-Make  edou A, et al. Beeneficial effects of
                                                                                                                                                                                                                    o oral magnesium  m
                                                                                                                                                            su
                                                                                                                                                             upplementation on    n insulin sensitivvity and serum lipid
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                                                                          ate Niak Pharrmaceuticals Co for provid    ding sincere m
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                                                                                                                                                               C             P, Sh
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                                                                          reserved to D
                                                                                      Dr. Naghi Shahhabi majd.                                              20010;134(2):119–1   129.
                                                                                                                                                          20. Corre
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                                                                           Conflict of IInterests                                                           Magnesium
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                                                                          The authors ddeclare that they have no co
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                                                                                                                                                                              I    2019 (6 Feeb); 33.2.                           5
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