Randomized
n=116
TRT
N=60
CNTL
n=56
Females(n=36)
40-55yrs(n=27)
56-70yrs(9)
Males(n=21)
40-55yrs(n=17)
56-70yrs(n=4)
Females(n=35)
40-55yrs(n=27)
56-70yrs(n=8)
Males(n=24)
40-55yrs(n=18)
56-70yrs(n=6)
Effectsofanoveldietarysupplementonphysicalandmentalfunctioninmiddle-agedadults:
Adouble-blind,randomized,placebo-controlledtrial
StevenMWood,PhD,RD;StephenPoole,BS;MarkBartlett,PhD;AngelaMastaloudis,PhD;DougBurke,PhD.CenterforAnti-AgingResearch,NuSkinEnterprises,Provo,UT
ABSTRACT#1076.8
INTRODUCTION
RandomizationandSubjectsCompletingStudy
RESULTS
SUMMARY/CONCLUSIONS/RECOMMENDATION
Agingischaracterizedbyagraduallossinphysicalandmentalfunctionstartingat30-40yearsofage.The
purposeofthisstudywastocompareanovelcombinationofCordycepssinensis,pomegranateextract,and
Panaxginseng(TRT)tocontrol(CNTL)formularegardingphysical,mental,andsexualdesire.Healthymales
andfemalesubjects(n=116)wererecruitedtoparticipateinaprospective,double-blind,randomized,
placebo-controlledtrialthatlasted60days.Subjectswererandomizedintoacontrol(n=56;CNTL)or
treatment(n=60;TRT)groupsandstratifiedbyageandgender.Mental(MCS)andphysical(PCS)wellbeing
weremeasuredbyvalidatedquestionnaires.Othermeasurementsincludedbloodchemistrymeasurements,
skincarotenoidconcentrations,andadverseevents.Thereweren=48inCNTLandn=47inTRTgroupsthat
completedthestudy.Nodifferencesweredetectedinthemeanscoresfor(PCS=CNTL;-0.47,TRT;-0.08)or
(MCS=CNTL;0.32,TRT;-1.98)andsexualdesirebetweengroupsnorbetweenage.Therewasastrongtrend
towardshigherskincarotenoidconcentrationsintheTRTgroup(P=0.052).Therewasnodifferencebetween
groupsforadverseeventsorbloodchemistry.TheTRTformulationappearstobesafe.Wewereunableto
detectdifferencesinphysical,mental,andsexualdesireasseeninanimalstudiespresumablybecausethis
populationwassohealthyanddidn’tshowanagerelateddecline.Therewasaninterestingfindingthat
subjectsconsumingtheTRTformulationexperiencedatrendtowardshigherskincarotenoidconcentrations
andwarrantsfurtherinvestigationinapopulationwhichhasage-relateddeclineinphysical,mental,sexual
decline,orexperiencinggreateroxidativestress.
ResearchwassupportedbyNuSkinEnterprises,Provo,Utah
Table1.Subjectcompliance
Design,Subjects,andMethods
Table2.Physical(PCS),Mental(MCS),andSexualDesireScorefrombaseline
and8weeks
1.Productsweresafeandwelltolerated(nodifferencesinadverseevents,changesinlaboratoryvalues,orvitalsigns)
2.StrongtrendtowardshigherskincarotenoidconcentrationsintheTRTgroup(p=0.052)
3.Nodifferencesinphysical,mental,andsexualdesireasseeninanimalstudiespresumablybecausethispopulationwassohealthyanddidn’tshowanage
relateddecline
4.TRTgroupcompliancewaslowerandsomayhaveinfluencedabilitytodetectdifferences
5.Mayneedtostudyeffectsofblendlonger
6.TRTgroupexperiencedatrendtowardshigherskincarotenoidconcentrationsandwarrantsfurtherinvestigationsinceproductdidnotcontaincarotenoids
andmayindicateimprovedantioxidantstatus.
7.Recommendfurtherstudyofnovelformulationinpopulationexperiencingdeclineofphysicalandmentalvitality.
Agingischaracterizedbyagraduallossofvariousfunctionsstartingat30to40yearsofageandaffectingmost
bodysystemsinavariablebutpredictablepattern.Physicalfitness(muscularstrength,aerobiccapacity,and
muscularflexibility)usuallywaneswithage,whichpartlyexplainsconcomitantincreasesinbodyfatpercentage
andlossesinleantissuemass.Sexualdesiredeclineswithadvancingageinbothmalesandfemales.
Notonlydoesagingnegativelyaffectphysicalfunction,butthementaleffectsofagingsimilarlyworsenwithtime.
Cognitiveimpairmentandmemorydeteriorationaremoreprevalentamongthemiddle-agedpopulationthan
amongtheyoung.Overall,theprocessofagingultimatelydecreasesqualityoflifeacrossseveraldomains
includingphysical,mental,andsexual.
Wehaveidentifiedseveralnaturalingredientsandextractsthathavepotentialtoinfluencementalandphysical
functions.Panaxginseng(PG)isatraditionalmedicineinAsiancountriesthathasbeenusedforitstoniceffect
andpossiblecurativeandrestorativeproperties.Ginsengisnowusedbymillionsofpeopleworldwide
unfortunately,clinicaltrialsonthehealthbenefitsofginsenghavehistoricallybeenplaguedbysmallsamplesize,
variousconcentrationsandpreparations,andlackofadequatecontrolgroups.Wehavenotedthatatraditionally
usedfungus,Cordycepssinensis(CS),caninfluencephysicalperformanceandchangegeneexpressionprofileof
musclestoamoreyouthfulexpression.Pomegranate(Punisgranatum)hasalonghistoryofcultivationanduse
asanutritiousfoodandtraditionalmedicine.Analyticalcharacterizationofthebioactivecomponentsof
pomegranatefruitextract(PX)hasrevealedactiveconstituents,mainlyellagitanninsandphenolicacids.Other
phytochemicalsinpomegranateincludepolyphenols,catechins,gallocatechins,andanthocyaninssuchas
prodelphinidins,delphinidin,cyanidin,andpelargonidin.Wehaveincorporatedtheseingredientsintorodent
dietsandtestedtheformula’seffectsinmurinemodelsandhavefoundincreasedendurance,memory,andsexual
functionascomparedtocontroldiets.
Giventhepromisinganimalresults,theexcellentsafetyprofile,andthecomplementarymechanismsofactionof
Panaxginseng,Cordycepssinensis,andpomegranate,wetestedaproprietaryblendofPG,CS,PX(Treatment-
TRT)vscontrol--CNTL(similarinappearance)todeterminechangesinphysical/mentalfunction,skincarotenoids,
aswellassafetyasmeasuredbyadverseeventsandchangesinlaboratoryvaluesinhealthy,middle-agedadults.
?Prospective,randomized,placebo-controlled,double-blind,multicentertrial(Tucson,AZ,Houston,TX,and
Minneapolis,MN)
?Healthy,middle-agedadultsMalesandFemales(n=116)
?Subjectsstratifiedbyagegroup(40-55or56-70years)andgender
?Conductedover8weekswithTRTorCNTLsupplementation
?Changesinphysicalandmentalfunction
oPhysicalcomponentsummary(PCS)andmentalcomponentsummary(MCS)scoresfromstandardized
questionnaire,SF-36
oSexualdesirequestionsfromMedicalOutcomesStudy(MOS)SexualProblemsScore
?Comprehensivelaboratorytestsandvitalsigns
?Adverseevents
?Skincarotenoidscores(BioPhotonicScanner,NuSkinEnterprises,Provo,UT)
?StudywasapprovedbyanInstitutionalReviewBoard(IRB)andlistedonclinicaltrials.gov(#NCT01155076)
VariableProductGroup
CNTLTRTp-value
Percenttaken,allsubjects
Mean
SD
Minimum
Maximum
88.21
10.40
42.50
98.33
83.16
14.62
42.50
95.83
0.053
Percenttaken,males40-55
Mean
SD
Minimum
Maximum
86.67
13.01
44.17
98.33
78.94
17.98
43.61
93.33
0.225?
Percenttaken,males56-70
Mean
SD
Minimum
Maximum
92.22
5.09
86.67
96.67
91.67
1.67
90.00
93.33
0.866?
Percenttaken,females40-55
Mean
SD
Minimum
Maximum
87.84
10.93
42.50
95.00
85.97
10.56
47.50
95.00
0.555?
Percenttaken,females56-70
Mean
SD
Minimum
Maximum
90.49
3.30
86.11
95.00
77.96
19.95
42.50
95.83
0.101?
CNTLvs.TRT,ANOVAwithagegroupandsexascovariates
?Unpairedt-test
StudyProduct
CNTLTRTp-value
Day0Day56ChangeDay0Day56Change
PCS
Mean56.4957.050.5356.6657.941.180.457
SEM0.5010.4730.4790.6030.5340.667
MCS
Mean56.3456.370.2854.2356.672.150.105
SEM0.8440.8630.5920.9180.9441.020
SexualDesire
Score
Mean78.9780.781.7878.1479.602.850.640
SEM2.473.011.342.172.531.66
SkinCarotenoid
Score
Mean23147
.1
23126.0-969.724858.825875.21018.90.052
SEM1614.51396.2735.61154.51478.4701.7
Change,CNTLvs.TRT,ANOVAwithagegroupandsexascovariates
StudyProduct
RandomizationCNTL
n=56
GroupB
n=60
p-value
Earlywithdrawal8(14.3%)13(21.7%)0.3743
Reason:
Death
Investigatordecision
Subjectwithdrew
Losttofollow-up
Other
0
0
4
1
3
0
0
3
7
3
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