Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
DECISION-MAKING IN THE NUTRITION
SCIENCES: A CRITICAL ANALYSIS OF
SCIENTIFIC EVIDENCE FOR ASSESSING
HEALTH CLAIMS
1
_________
JUAN BAUTISTA BENGOETXEA1
1h ps://o cid.o g/0000-0003-1158-1122
Uni e si y o he Balea ic Islands
Depa men o Philosophy
Palma de Mallo ca, Islas Balea es
Spain
juanbau is a.bengoeche[email p o ec ed]
OLIVER TODT2
2h ps://o cid.o g/0000-0001-9363-05432
Uni e si y o he Balea ic Islands
Depa men o Philosophy
Palma de Mallo ca, Islas Balea es
Spain
[email p o ec ed]
A icle in o
CDD: 501
Recei ed: 04.04.2021; Re ised: 23.06.2021; Accep ed: 25.06.2021
h ps://doi.o g/10.1590/0100-6045.2021.V44N3.JB
1
Aknowledgmen
This wo k was suppo ed by he Eu opean Commission Eu opean
Regional De elopmen Fund (ERDF-FEDER)/ Spanish Minis y
o Science and Inno a ion – S a e Resea ch Agency (AEI),
esea ch p ojec FFI2017-83543-P (‘Es ánda es de p ueba y
elecciones me odológicas en la undamen ación cien í ica de las
decla aciones de salud’) and esea ch p ojec PID2020-113449GB-
I00 (‘Las polí icas epis émicas en la ciencia egulado a: e aluación
de iesgos y e aluación de bene icios’).
Decision-Making in he Nu i ion Sciences 43
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
Keywo ds
Heal h-Claim
E idence
Nu i ion
Decision-Making
RCT
Expe ise
Abs ac : In his pape we p esen an analysis o he ole o
andomized con olled ials (RCTs) in he egula ion o heal h
claims (claims abou addi ional heal h bene i s p o ided by oods).
Cu en ly he e is a line o hough in he nu i ion sciences and in
egula ion ha da a om RCTs may be able o minimize, o e en
make supe luous, he ole played by expe knowledge in decision
making. We analyze he limi a ions o , as well as he possible
in e en ion o expe judgmen in RCTs in pha macology and
nu i ion. As a esul o ou analysis, we a gue ha bo h RCTs and
expe knowledge a e necessa y o da a gene a ion in heal h claim
egula ion. We a gue ha as a as da a gene a ion is conce ned,
nu i ion is mo e complex han pha macology, implying ha RCTs
a e mo e di icul o e ec i ely design and execu e. Wha he la e
means is ha in nu i ion and heal h claim egula ion, expe
knowledge is e en mo e impo an han in pha macology.
1. In oduc ion: chasing scien i ic e idence
In his pape we p opose a c i ical analysis o he
scien i ic me hods used o gene a e e idence in he decision-
o ien ed sciences (he eina e , DOSS).
2
Ou mo i a ion is he
2
The use o scien i ic e idence is pa ially dic a ed by di e en
conside a ions—p agma ic and epis emic, o ins ance—in o de
o make a decision on he egula ion o a subs ance o p oduc (like
chemical compounds, no el oods, o d ugs). The decision-
Juan Bengoe xea & Oli e Tod 44
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
o en ci ed assump ion ha andomized con olled ials (RCTs,
clinical ials) on heal h claims a e he bes means—
some imes he only way— o ob ain decision- ele an ,
objec i e scien i ic e idence,
3
meaning ha he ecou se o
expe knowledge is in many cases conside ed seconda y. In
o he wo ds, he ad oca es o RCTs conside ha i may be
possible o make expe judgmen mos ly supe luous in
DOSS.
E idence se es as inpu o making decisions in di e en
ields o esea ch and policy (Achins ein 2001, Ca w igh
2015). One impo an way o ob aining unbiased e idence is
he andomized con olled ial (Hacking 1983). The objec i i y
p oduced by RCTs is based on he use o con ol g oups
(which a e gi en a placebo o an ac i e con ol), alongside
he expe imen al ones. T ials o , o ins ance, d ugs on he
basis o he RCT design a e gene ally conside ed o be able
o show e icacy o he compound unde s udy (Rubin 1974,
Papineau 1994).
In obse a ional o expe imen al da a collec ion
p ocesses, a c ucial condi ion on expe imen s is, especially in
o ien ed sciences a e hose disciplines o knowledge whose wo k
depends upon ha kind o use.
3
We a e alluding o he iple objec i i y cons i u ed by wha
Koskinen (2020, p. 1191), om he se en kinds o objec i i y
p esen ed by Douglas (2004), summa ized as con e gen , p ocedu al
and in e ac i e objec i i y— ha is, he each o he same esul s ia
di e en means, he eplacemen o one esea che by ano he
wi hou al e ing he esul , and a esea ch communi y’s u ge o
os e s di e se c i ical exchanges. In addi ion, we would like o
emphasize ha in his pape we ocus on enhanced unc ion heal h
claims, unlike he ype ha , o ins ance, Jukola (2019, p. 4)
examines in mo e de ail: he heal h claims ela ed o nu i ion
guidelines ha migh help minimize ce ain diseases on he le el o
an en i e popula ion.
Decision-Making in he Nu i ion Sciences 45
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
social sciences and medicine, ha hey mus be cons ained
in one way o ano he . Gi en ha , depending on each
si ua ion, he use o causal in e ence me hods becomes
necessa y, andomiza ion has become a key concep in
expe imen al me hods. The bes s a egy o a oiding
'con ounde s', o example, is he andomiza ion o a
ea men (Illa i and Russo 2014). This is a means aimed a
elimina ing bias due o uncon olled di e ences in
expe imen al condi ions. Bu andomiza ion p esen s
p oblems o i s own. Due o he complexi y o phenomena
and en i onmen al condi ions in biomedical o social
con ex s, andomiza ion has been imposed as he basis o
RCTs, on which mos e idence-based app oaches a e based.
Two c ucial ideas o RCTs a e: (1) he andom applica ion o
a ea men in expe imen al subjec s (like labo a o y mice o
human pa ien s) minimizes he p oblem o bias and
con ounding, and (2) in o de o es ablish he e icacy o a
ea men , he esul s ob ained om he es g oup a e
compa ed wi h hose o he con ol g oup. In addi ion,
RCTs can wo k wi h many indi iduals o wi h jus one ( ial
n, ial 1) and can be blind o double blind (Jukola 2019, p.
2).
The c ucial issue is, howe e , ha his idealized se up o
clinical ials, which is he basis o expe imen a ion and
assessmen in pha macology (Luján and Tod 2021), is no
su icien as a basis o egula o y decision making, unless i
is combined wi h expe judgmen . This is an a gumen
al eady being s udied in he ield o pha maceu icals, and
he e we aim o analyze his same a gumen in he case o
nu i ion. Al hough a DOSS linked o medicine o
pha maceu icals es ing can p o ide some equali y and
balance acco ding o he s anda ds o egula o y agencies
like, o ins ance, he FDA (US Food and D ug
Adminis a ion), we wan o emphasize ha se e al
Juan Bengoe xea & Oli e Tod 46
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
me hodological p oblems o a ious kinds ha e a isen
(T usswell 2001, pp. 1061-1062). We a e in e es ed he e in
examining hese di icul ies in o de o shed ligh on he
managemen o he no ion o scien i ic e idence in heal h
claim egula ion (Tei a and Reiss 2013, p. 209; Sacke e al.
1996, pp. 71-72).
We ag ee wi h S egenga’s a gumen (2015) in many
espec s when he examines and quali ies in e nal ing edien s
ypical o clinical esea ch p ocedu es, and iden i ies h ee
key p oblems in measu ing he e icacy o medical
in e en ions: use o de ec i e o poo measu ing
ins umen s (S egenga 2015, pp. 63-65), con using analy ical
ope a ions (in e p e a ion o chosen pa ame e s and o
ins umen s used o assess whe he o no an in e en ion
modi ies he pa ame ic alues) (S egenga 2015, pp. 65-68),
and he assump ion ha measu emen s wi hin a speci ic
expe imen al se up a e su icien o allowing o possible
ex apola ion o o he ields o applica ion (S egenga 2015,
pp. 68-70). The au ho claims ha he esponse o hese
p oblems usually unde mines he ole o expe judgmen
and o e es ima es he e ec i eness o clinical in e en ions.
Ad oca es o RCTs conside ha s a is ical ools a e
impa ial and impe ious o pa icula in e es s ha
o he wise could bias he judgmen o he indi idual expe .
Then, and only a e applying RCTs, he “au oma ic
objec i i y” an RCT p o ides should be checked agains
expe judgmen in a con inuous a emp o in eg a e expe
judgmen — he expe by he own may be misin o med,
pa ial, biased o a ‘malp ac i ione ’—wi h some kind o
mechanical objec i i y (Van Baalen and Boon 2015).
RCTs a e c i ically impo an o heal h claim egula ion.
Heal h claims a e s a emen s ha indica e ha a ood o ood
ing edien o e s posi i e heal h e ec s beyond i s simple
nu i ional alue. Heal h claims a e subjec o egula ion in
Decision-Making in he Nu i ion Sciences 47
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
many coun ies, due o he added alue which hey p o ide.
They a e usually egula ed by he na ional o a common ood
egula o (like, o ins ance, he U.S. Food and D ug
Adminis a ion o he Eu opean Food Sa e y Au ho i y
EFSA). A p ima y objec i e o heal h claim egula ion, apa
om acili a ing o icially sanc ioned in o ma ion o
consume s who wan o imp o e hei heal h, is o p o ec
consume s om alse o misleading claims, bu also o
p o ec inno a i e ood p oduc s, as well as p omo e public
heal h.
While he e a e di e ences be ween he ways heal h
claims a e egula ed in, e.g., he Uni ed S a es, Japan, o
Eu ope, all o hose egula o y amewo ks conside
nu i ion RCTs o p o ide he bes e idence o egula o y
au ho iza ion. Tha is he eason why RCTs ha e become
c ucially impo an o egula ing many heal h claims. In ac ,
he RCT me hodology was adap ed om pha maceu icals
es ing, and ans e ed o he nu i ion ield, in he hope o
p o iding nu i ion esea ch wi h an “objec i e” basis. As we
will see, he e exis s deba e abou he adequacy o lack
he eo o RCTs in nu i ion.
In o de o c i ically analyze he gene a ion o e idence
o DOSS and pa icula ly o heal h claim egula ion, we
ha e s uc u ed he ex as ollows: In sec ion 2, we analyze
he s anda d way o ob aining e idence acco ding o he
design and p ocedu es o pha maceu ical RCTs. We examine
he con o e sial issue o whe he medical-s yle RCTs, gi en
some o hei me hodological limi a ions, a e in ac he bes
ool o gene a ing e idence in nu i ion. The high e iden ial
s a us o RCTs is ques ionable in nu i ion since da a
gene a ion in his la e ield u ns ou o be mo e complex
han in he ield o pha maceu icals. In sec ion 3, we ocus
on he ob ainmen o e idence in nu i ion, discuss i s
pu a i e objec i e na u e, and p esen some c ucial
Juan Bengoe xea & Oli e Tod 48
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
di e ences be ween nu i ion science and pha macology. In
sec ion 4, we p esen se e al examples ha show he
limi a ions o RCTs o gene a ing da a in nu i ion, and
poin o he impo ance o expe judgmen . In sec ion 5 we
conclude a guing o he necessa y complemen o RCTs
and expe knowledge in egula o y decision making.
2. RCTs and p oblems ela ed o au oma ic objec i i y
in pha macology
Cu en ly he e is an ongoing discussion abou he
epis emic ounda ions o RCTs (Ca w igh 2010). I RCTs
a e concei ed, as Ca w igh does,
4
as ools o making causal
in e ences―which is no he only way o in e p e hem―,
hei impa iali y can be unde s ood as a use ul byp oduc o
egula o y decisions. I we can objec i ely es ablish ha a
cause (say, a d ug) is e ec i e in ob aining an e ec (say,
cu ing a disease), he es ablishmen o he e ec can be
conside ed independen o any in e es ha migh be
in ol ed in he RCT (Ca w igh and Ha die 2012, Haywa d
and K umholz 2012, pp. 2-5, Rubin 1974, p. 700, U bach
1985, Van Baalen and Boon 2015, Wo all 2010).
Bu causali y p esen s p oblems. Es ablishing causa ion is
a e y igid e iden ia y condi ion. The design and execu ion
o RCTs in o de o ob ain he necessa y da a equi es a lo
4
Making causal in e ences on he basis o nu i ion RCTs is
undamen al o hei egula ion. In Eu ope, o ins ance, he
egula o y agency esponsible o egula ing heal h claims ( he
Eu opean Food Sa e y Au ho i y, EFSA) conside s ha RCTs a e
he bes scien i ic me hod o gene a ing da a as basis o
au ho iza ion o claims because RCT da a allow o he
es ablishmen o causal ela ionships be ween inges ion o a ood
o ing edien and he desi ed posi i e heal h e ec (Heaney 2008).
Decision-Making in he Nu i ion Sciences 49
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
o esou ces and ime. As an example, only e y ew heal h
claims ha e been au ho ized in Eu ope due o he challenge
o es ablishing causali y be ween inges ion and he desi ed
ou comes. In a pe spec i e ha closely ollows Luján and
Tod ’s me hodological plu alism (2021, p. 31), we a gue ha
in he nu i ion ield expe pa icipa ion in decision making
is e en mo e ele an han in medicine and pha macology
because in nu i ion many o he ele an ins i u ions,
p o ocols, p ocedu es (and e en s akeholde s) a e nei he
well es ablished no su icien ly ma u e. Only expe s can
p o ide he necessa y knowledge and judgmen ha in
medicine in many cases has al eady been ins i u ionalized
and codi ied.
Con olling and checking assignmen s such as he
andomiza ion decisions du ing ials, as well as he decision
o wha compound o submi o es ing, is some hing ha
demands expe judgmen , which goes beyond me e
s a is ical calcula ions. Agains he ideal o an “au oma ic
objec i i y”, we need expe ise ha can manage mul iple
sou ces o e idence in o de o be able o e i y ha causal
assump ions ha e been ul illed. And we also need someone
who can ce i y ha andomiza ion has ac ually been
success ul. Wi hou mo e o less subjec i e expe judgmen ,
we canno a i e a wa an ed gene aliza ions om he
conclusions o he ial o he a ge popula ion—we canno
asce ain i s ex e nal alidi y; i.e., he kind o alidi y ha has
o do wi h whe he he esul ha is es ablished in an RCT
will be ue in o he , al e na i e implemen a ions, as well as
he eal wo ld (Jiménez-Buedo and Mille 2010; Ca w igh
2010, p. 60).
In sum, he ex e nal alidi y o RCTs has o be e i ied in
p ac ice. We can see his when a egula o ( he FDA, o
ins ance) collec s pos -ma ke ing epo s, pa icula ly
ad e se epo s, om di e en sou ces, and di ec s
Juan Bengoe xea & Oli e Tod 50
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epidemiological s udies ha assess hei ele ance (Jiménez-
Buedo and Mille 2010). This ac can indica e ailu es in he
ials. In pha macology labeling e iews and wi hd awal om
he ma ke se e as checks on he ex e nal alidi y o FDA-
app o ed p e-ma ke ing ials.
5
While da a gene a ed by
RCTs gene ally allow o es ablish he main e ec s o a d ug,
hey canno gua an ee ha all possible seconda y e ec s a e
accoun ed o . One o he main easons o he la e is ha
pha macological ials a e conduc ed in s ic ly con olled
en i onmen s and wi h highly limi ed popula ions ( he
espec i e expe imen al and con ol g oups). Real-wo ld use
o d ugs (o oods, o ha ma e ) occu s, howe e , in
con ex s ha can di e signi ican ly om he one o p e-
ma ke ing ials. RCTs a e designed o y o cap u e ele an
aspec s o his eal-wo ld con ex , bu hei limi ed na u e
means ha he e simply canno be any gua an ee ha
p e iously unknown e ec s migh no c op up in he
ma ke ing s age. Hence he need o pos -ma ke ing
moni o ing (Ca w igh and Ha die 2012, p. 125).
A lo o o mal and in o mal knowledge is acqui ed in he
p ocess o es ing a d ug, knowledge ha is es ed no only
h u RCTs, bu also by subsequen moni o ing (which is
mo e akin o an epidemiological s udy) a e he d ug ob ains
egula o y app o al. And i u ns ou ha expe judgmen
con ibu es o he each and e e y pa o his en i e p ocess.
E en i he decision o au ho ize a d ug is aken on he basis
o RCT da a, he decision is no an au oma ic one p ecisely
because he ex e nal alidi y o a ial canno be gua an eed
(Tei a and Reiss 2013, p. 215).
5
We e e o he ex apola ion o esul s— alid o an examined
popula ion (in e nal alida ion)— om one popula ion o an
al e na i e popula ion (see Illa i and Russo 2014, pp. 17 ).
Decision-Making in he Nu i ion Sciences 57
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
and Tapsell 2019). One o he p incipal easons is ha he
es ablishmen o causali y is, as we ha e al eady seen, a e y
challenging equi emen . In ac , he e is a di e si y o
sou ces o e idence anging om animal s udies and
molecula biology o he c i ical in e p e a ion o
obse a ional epidemiology. I is clea ha he RCT
me hodology migh be pa ially inadequa e o assess nu ien
e ec s, bu a he same ime i s abili y o minimize bias is
c ucial o egula o y decision making.
4. Heal h-claims, e idence, and expe judgmen o
decision making in nu i ion
In egula ion, s anda ds o p oo a e impo an o he
aking o decisions (S eel 2015; Reiss 2015). Tha is because
i is he s anda d o p oo ha indica e which ype and le el
o e idence o equi e. In many cases s anda ds o p oo
make i possible o de ine hie a chies among di e en ypes
o e idence. Such hie a chies a e a ele an ool in egula ion
because hey indica e he ype o scien i ic me hodology o
be p e e ed when analyzing, o ins ance, he ela ionship
be ween exposu e o a pa icula chemical subs ance and a
heal h p oblem, o be ween consump ion o a ood and
de ined posi i e heal h e ec s (Luján and Tod 2021).
As a gene al ule, heal h claims all in o he ca ego y o
bene i assessmen . Bu we ha e o dis inguish di e en
ypes o heal h claims. We can dis inguish be ween heal h
claims di ec ly aimed a exposing heal h bene i s and heal h
claims aimed a showing ha a ood (o ing edien ) se es o
educe he isk o a disease. This second case is he one ha
Jukola (2019) ocuses on. She examines he assessmen o
e idence in he case o nu i ion guidelines a he popula ion
le el, whe e he main issue is o unde s and how a ce ain
Juan Bengoe xea & Oli e Tod 58
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
ype o die can p e en ch onic diseases. To he con a y,
we emphasize di ec bene i s ha conce n hose assessmen s
o e idence ocused on enhanced unc ion claims on oods
o hei ing edien s.
In 1995, he Eu opean Union (EU) and he Eu opean
ILSI (In e na ional Li e Sciences Ins i u e) s a ed he
FUFOSE p ojec (Func ional Food Science in Eu ope) in
o de o c ea e a new app oach o e alua ing scien i ic
e idence necessa y o he de elopmen o unc ional oods
(Agge e al. 2010).
8
I s p ima y aim was o adequa ely
cha ac e ize he no ion o heal h claims, whe he concei ed
as enhanced unc ion claims o as educ ion o disease isk
claims (Aga wal e al. 2006). In o de o implemen he
conclusions and p inciples o FUFOSE, in 2005 he
PASSCLAIM P ojec (P ocess o he Assessmen o
Scien i ic Suppo o Claims on Foods) was s a ed, whose
inal e sion de ined se e al c i e ia o subs an ia e a heal h
claim. The EU’s Heal h Claim Regula ion (Eu opean
Pa liamen and Council 2006) has since sough o make i
easie o he consume o choose scien i ically subs an ia ed
claims and o communica e bene i s om ood, p o ided
ha he claim is ac ually subs an ia ed scien i ically (A . 6.1)
(Asp and B yngelsson 2008).
The use o scien i ic e idence in egula ion ollows
c i e ia de ined by EFSA’s ele an scien i ic commi ee, he
NDA Panel (NDA Panel EFSA, 2011).
9
Taking hese c i e ia
8
On con o e sies wi h espec o ILSI, see
h ps://co po a eeu ope.o g/si es/de aul / iles/ilsi-a icle-
inal.pd .
9
The scien i ic da a ha e been s uc u ed acco ding o hei
ele ance in his o de : (1) human in e en ion s udies, (2) human
obse a ional s udies, (3) o he human s udies, and (4) non-human
Decision-Making in he Nu i ion Sciences 59
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
in o accoun , in he ollowing we e iew a numbe o issues
ha ques ion he idea o being able o gene a e da a on causal
ela ionships be ween in ake and ou come wi hou ecu ing
o expe judgmen .
[Food ma ix] In o de o e i y he e ec s o a nu ien
o ood componen , i is necessa y o cha ac e ize ce ain
backg ound condi ions ha e lec he ood ma ix (backg ound
die ), as well as he die a y con ex o he in ake o he
nu ien unde s udy. The ood ma ix can decisi ely
in luence he elease and ac i i y o he ing edien in ques ion
(PASSCLAIM 2005). I is he e o e impo an o calib a e
his in luence. Fo example, using wa e - ee in i o ood
sys ems allows o compa e he elease o he componen s o
he di e en die a y ma ices (Rie jens and Alink 2006). This
shows ha in nu i ion science any RCT da a used o
asce ain e ec s om oods a e ypically mo e complex han
hose used in pha macology, because ce ain ea u es o
nu i ion se i apa om pha macology—low e ec i e
doses, in e ac ion among all o he ing edien s in ol ed,
in e play be ween he ing edien s unde s udy and he ood
ma ix, as well as ela i ely long la ency pe iods (Hend ickx
2013).
[Ex apola ion] In nu i ion science, as a DOSS, ew
esul s a e ex ensible o all oods and ood componen s. A
heal h claim ob ained wi h a pa icula die o ood ma ix
canno always be ex apola ed o a second p oduc wi h he
same componen in a di e en ood ma ix ( he nu ien and
non-nu ien componen s o oods). Applying he use o an
exis ing heal h claim o a p oduc wi h ano he composi ion
equi es e idence o he in a iance o unc ional e icacy,
da a as e idence o suppo ing claims (EC, 2008; see also EFSA
(NDA Panel, Regula ion (EC) No 1924/2006, 2011, p. 2021).
Juan Bengoe xea & Oli e Tod 60
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
which in u n may equi e a sepa a e subs an ia ion o he
epo ed e ec o each indi idual p oduc .
[Consis ency] Along wi h he cha ac e iza ion o he
backg ound die and o he ele an aspec s o he s udy
g oups’ li es yle (PASSCLAIM 2005, p. 17)—whe e he use
o independen ma ke s o in ake and exposu e helps
inc ease he quali y o da a on die a y in ake—,
10
ano he
impo an poin is he consis ency be ween he amoun o
ood and he in ended pa e n o consump ion: he amoun
should app oxima e o coincide wi h i s in ended use, he
o m and he equency o he in ake. Whe e dose- esponse
s udies a e pe o med (concen a ion-e ec ), he dose ange
usually includes he amoun o ood expec ed o be
consumed (Neale and Tapsell 2019, p. 3; Jacobs and Tapsell
2013). In he ood supplied o he con ol g oup o a ial he
ing edien s unde s udy will be ei he absen o p esen in a
known and signi ican ly di e en ―usually much
lowe ―concen a ion wi h espec o he amoun p esen in
he es ed ood. The analy ic p ocedu e unde ce ain
ci cums ances may also ha e subjec i e e ec s ha migh
no ac ually be ela ed o speci ic e ec s o he es ed
subs ance i sel . These e ec s can be placebo o nocebo
phenomena, and may be conside ed in he s udy design.
[Accu acy] Me hodological accu acy equi es ha he
exposu e and moni o ing o he ood a e adequa e. This
in ol es a su icien ly la ge obse a ion pe iod (pe iod o
in ake) in o de o show ha he expec ed e ec exis s and,
10
Whene e expe imen e s do no ha e alid ma ke s o exposu e
a hand, in akes can be calcula ed acco ding o he amoun and
composi ion o he ood consumed, which equi es no only ha
subjec s eliably epo on hei ood in ake, bu also ha eliable
in o ma ion abou he composi ion o ood o ha popula ion is
a ailable om a da abase.
Decision-Making in he Nu i ion Sciences 61
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
i necessa y, ha i can be main ained o e ime. Since he
pe iod o obse a ion may ange om a ew seconds o
se e al weeks (s e ol-induced changes in choles e ol
me abolism) o yea s (changes in bone densi y due o
calcium), meaning ha s udies migh in p ac ice be ex emely
challenging o e en impossible, i can be necessa y o ecu
o al e na i e app oaches o assess epo ed bene i s, such as
he use o bioma ke s.
In iew o he abo e, and gi en ha some o he basic
cha ac e is ics o RCTs in pha macology (blinding o
pa icipan s and in es iga o s, use o app op ia e con ols,
choosing con ol g oups, ime un il a ele an ou come is
p oduced, e c.) u n ou o be highly p oblema ic in he ield
o nu i ion, we can conclude ha many RCTs— pa icula ly
long- e m ones—a e di icul o e en imp ac ical in nu i ion
esea ch (Neale and Tapsell 2019, p. 6). This implies wo
conclusions: 1) i may be necessa y o ecu o me hodologies
o he han RCTs o gene a e da a, like coho s udies—
esea ch used o in es iga e he causes o disease, and o
es ablish links be ween isk ac o s and heal h ou comes—
and 2) expe knowledge becomes c ucially impo an . In
o he wo ds, he me hodological limi a ions o RCTs and he
need o da a om o he , non-RCT sou ces in nu i ion
esea ch mean ha expe s a e e en mo e impo an in
nu i ion (and ela ed egula o y decisions) han in he ield
o pha macology. We ag ee wi h Schwingshackl e al. (2016)
and Neale and Tapsell (2019, p. 6) ha one pa ial solu ion
o his di icul y may be sco ing sys ems ha allow o
e alua e he quali y o he e idence gene a ed by RCTs (like,
o ins ance, Nu iG ade). Good sys ema ic e iews could ake
ad an age o a amewo k like his, al hough ins i u ions and
companies should inance his ype o e idence p oduc ion
con ol, a leas i we do no wan misin o ma ion o
Juan Bengoe xea & Oli e Tod 62
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
cons an ly sneak in o con ol p og ams quali y (See
Schwingshackl e al. 2016).
5. Conclusions
Randomiza ion equi es he concu ence o expe
judgmen because, as we claim, he “au oma ic objec i i y”
asc ibed o RCTs is insu icien o aking alid egula o y
decisions. Assessmen s, in o de o be use ul, ha e o ely on
he assessmen o da a om di e se sou ces o e idence. The
la e implies he concu ence o a a ie y o scien i ic
me hodologies, which in p ac ice makes expe judgmen
indispensable. Expe judgmen , in o he wo ds, is a
necessa y complemen o “objec i e” RCT da a. E en mo e,
expe in e en ion may also be equi ed when designing and
execu ing RCTs. Fo ins ance, i is unlikely ha RCT
e idence can be adequa ely gene a ed wi h espec o he ole
a nu ien plays in endpoin s o non-indexed diseases
wi hou aking accoun o expe judgmen . Much o he
e idence ega ding nu ien s and non-indexed diseases will
in he end ha e o ecu o a wide a ie y o me hods,
among hem mechanis ic and obse a ional s udies.
In his pape we ha e analyzed whe he ob ainmen o
scien i ic e idence by way o RCTs is he mos adequa e (o
e en he only alid) p ocedu e o egula o y decision
making in he ield o nu i ion. I is clea ha minimiza ion
o bias is a key cha ac e is ic o RCTs. Bu his is no
su icien o excluding o he e idence om decision
making. I is necessa y o ake in o accoun o he s a egies
o modeling e idence (Zeiss and an Egmond 2014), since
esea che s in mos cases a e in e es ed no only in p edic ing
he e ec s o a nu ien , bu also in explaining i , o applying i
unde condi ions o high unce ain y. The e o e,
Decision-Making in he Nu i ion Sciences 63
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
pha macology-s yle RCTs, gi en hei me hodological
limi a ions, a e no adequa e as exclusi e ools o gene a ing
scien i ic e idence in nu i ion, since he gene a ion o
egula ion- ele an da a in his ield ends o be mo e
complex han in pha macology. The RCT me hodology
needs o be complemen ed and 'in e p e ed' (shaped) wi h
empi ical nu i ional in o ma ion ( ood de ails, da a on he
po en ial consume , e c.), jus as in physical-ma hema ical
models he ini ial condi ions, he bounda y condi ions and
o he elemen s a e aken in o accoun in o de o ob ain
unbiased and objec i e ou comes (Ga za e al. 2019).
In sho , we ha e examined he na u e and quali y o
e idence gene a ed by RCTs o enable scien is s and
egula o s o judge and manage decisions abou he
accep abili y and u h ulness o heal h claims. Ou analysis
shows ha bo h RCTs and expe knowledge a e join ly
necessa y in da a gene a ion o egula ion and decision
making. As we ha e a gued, e en in pha macology RCTs
depend on expe inpu . In sec ion 4 we ha e seen ha as a
as da a gene a ion is conce ned, nu i ion is mo e complex
han pha macology, implying ha RCTs a e mo e di icul o
e ec i ely design and execu e. Wha he la e means is ha
in nu i ion and heal h claim egula ion, expe knowledge is
e en mo e impo an han in pha macology.
Re e ences
ACHINSTEIN, P. The Book o E idence. Ox o d: Ox o d
Uni e si y P ess, 2001.
AGARWAL, S., HORDVIK, S., MORAR, S. “Nu i ional
claims o unc ional oods and supplemen s”.
Toxicology, 221, pp. 44-49, 2006.
Juan Bengoe xea & Oli e Tod 64
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
AGGETT, P., ANTOINE, J.-M., DE VRIES, J.,
GALLAGHER, A., HENDRIKS, H.,
KOZIANOWSKI, G., MEIJER, G.,
RICHARDSON, D., RONDEAU, V., TWEEDIE,
G., WELCH, R. (ILSI), “Beyond PASSCLAIM –
Guidance o subs an ia e heal h claims on oods”.
ILSI Eu ope Repo Se ies, pp. 1-24, 2010.
ASP, N.-G., BRYNGELSSON, S. “Heal h claims in
Eu ope: new legisla ion and PASSCLAIM o
subs an ia ion”. Jou nal o Nu i ion, 138, pp. 1210S–
1215S, 2008.
BLUMBERG, J., HEANEY, R.P., HUNCHAREK, M.,
SCHOLL, T., STAMPFER, M., VIETH, R.,
WEAVER, C.M., ZEISEL, S.H. “E idence-based
c i e ia in he nu i ional con ex ”. Nu i ion Re iews,
68, pp. 478-484, 2010.
BOWEN, S., ZWI, A.B. “Pa hways o ‘E idence-In o med’
Policy and P ac ice: A F amewo k o Ac ion”. PloS
Medicine, 2, pp. 0600-0605, 2005.
CARTWRIGHT, N. “Wha a e andomised con olled ials
good o ?”. Philosophical S udies, 147, pp. 59-70, 2010.
_____. E idence: Fo Policy, and Whe esoe e Rigo is a Mus .
London: LSE, 2015.
_____., HARDIE, J. E idence-Based Policy: A P ac ical Guide o
Doing I Be e . Ox o d: Ox o d Uni e si y P ess, 2012.
DE BOER, A., VOS, E., BAST, A. “Implemen a ion o he
nu i ion and heal h claim egula ion – The case o
an ioxidan s”. Regula o y Toxicology and Pha macology, 68,
pp. 475-487, 2014.
DOUGLAS, H. “The I educible Complexi y o
Objec i i y”. Syn hese 138, pp. 453-473, 2004.
Decision-Making in he Nu i ion Sciences 65
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
EFSA. Scien i ic and echnical guidance o he p epa a ion
and p esen a ion o an applica ion o au ho isa ion
o a heal h claim (Re ision 1). EFSA Jou nal, 9, 2170,
pp.1–36, 2011.
EUROPEAN PARLIAMENT AND COUNCIL. 2006.
Regula ion (EC) 1924/2006 o he Eu opean
Pa liamen and o he Council o 20 Decembe 2006
on nu i ion and heal h claims made on oods. O icial
Jou nal o he Eu opean Union L.404: 9-25.
EU, 2002. “Regula ion (EC) No 178/2002 o he Eu opean
Pa liamen and o he Council o 28 Janua y 2002
laying down he gene al p inciples and equi emen s
o ood law, es ablishing he Eu opean Food Sa e y
Au ho i y and laying down p ocedu es in ma e s o
ood sa e y.” Chap e 11 ‘Gene al Food Law’, A icle 6
‘Risk analysis’ and a icle 14 ‘Food sa e y equi emen s’.
O ficial Jou nal o he Eu opean Communi ies (1.2.2002),
L31, 34 pp. (A ailable a : h p://eu -
lex.eu opa.eu/legal-
con en /EN/TXT/PDF/?u i=CELEX:32002R0178
& om=en. Accessed on May 9 h, 2020).
GARZA, C., STOVER, P.J., OHLHORST, S.D., FIELD,
M.S., STEINBROOK, R., ROWE, S., WOTEKI, C.,
CAMPBELL, E. “Bes p ac ices in nu i ion science
o ea n and keep he public’s us ”. The Ame ican
Jou nal o Clinical Nu i ion, 109, pp. 225-243, 2019.
GOODMAN, K. E hics and E idence-Based Medicine: Fallibili y
and Responsibili y in Clinical Science. Camb idge:
Camb idge Uni e si y P ess, 2003.
HACKING, I. Rep esen ing and In e ening. Camb idge:
Camb idge Uni e si y P ess, 1983.
Juan Bengoe xea & Oli e Tod 66
Manusc i o – Re . In . Fil. Campinas, . 44, n. 3, pp. 42- 69, Jul.-Sep. 2021.
HAYWARD, R.A., KRUMHOLZ, H.M. “Th ee easons o
abandon low-densi y lipop o ein a ge s”. Ci cula ion,
5, pp. 2-5, 2012.
HEANEY, R.P. “Nu ien s, Endpoin s, and he P oblem o
P oo ”. The Jou nal o Nu i ion, 138, pp. 1591-1595,
2008.
HENDRICKX, K. “Ri aling e idence-bases and poli ics in
egula o y science”. Food, Science & Law, 4, 2013
[h p://hdl.handle.ne /2268/162196] (Access: May
29, 2021).
HSIANG-K., C., SZU-T., C., MILLSTEIN, R.L. Mechanisms
and Causali y in Biology and Economics. Do d ech ,
Sp inge , 2013.
ILLARI, P., RUSSO, F. Causali y: Philosophical Theo y Mee s
Scien i ic P ac ice. Ox o d: Ox o d Uni e si y P ess,
2014.
JACOBS, D.R., TAPSELL, L.C. “Food syne gy: he key o a
heal hy die ”. P oceeding o he Nu i ion Socie y, 72, pp.
200-206, 2013.
JIMÉNEZ-BUEDO, M., MILLER, L.M. “Why a T ade-
O ? The Rela ionship be ween he Ex e nal and
In e nal Validi y o Expe imen s”. Theo ia 69, pp. 301-
321, 2010.
JUKOLA, S. “On he e iden ia y s anda ds o nu i ion
ad ice”. S udies in His o y and Philosophy o Biological and
Biomedical Sciences 73, pp. 1-9, 2019.
