Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Phase: PHASE1
Conditions: Obesity, Healthy
Sponsor: Mayo Clinic

 
 
 
Effect of Ileocolic-released Conjugated Bile 
Acid on Satiety, Entero-Endocrine Cell Function, 
and Body Weight in Patients With Obesity and 
Abnormal Satiety Phenotype 
 
NCT#05314374 
 
14June2023 

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E F F E C T O F I L E O C O LI C-R E L E A S E C O NJ U G A T E D BI L E  
A CI D O N S A TI E T Y , E N T E R O -E N D O C RI N E C E L L 
F U N C TI O N , A N D B O D Y W EI G H T I N P A TI E N T S  WI T H 
O B E SI T Y  A N D A B N O R M A L S A TI E T Y P H E N O T Y P E  
Pri nci p al I nv esti g at or:
Pri nci p al I nv esti g at or:     
•  
A n dr es Ac ost a M. D., P h. D. Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, 
M ay o Cli nic, R oc h est er, M N   
 
C o
C o -I nv esti g at or:
I nv esti g at or:   
•  
Mic h a el C a mill eri, M. D.   Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o 
Cli nic, R oc h est er, M N     
•  
Ry a n L e n n o n, M. S. , Divisi o n of Cli nic al Tri als a n d Bi ost atistics , D e p art m e nt of Q u a ntit ativ e H e alt h 
Sci e nc es , M ay o Cli nic, R oc h est er, M N.   
 
R es e arc h F ell o ws: 
R es e arc h F ell o ws:  
•  
Wiss a m G h us n  M. D. Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o 
Cli nic, R oc h est er, M N     
•  
Si m a F a ns a , M. D. Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N     
•  
Di e g o A n azc o  M. D. Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N     
K ey P ers o n n el 
K ey P ers o n n el  
•  
D u a n e B urt o n M. A . Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N.  
•  
J essic a Stutz m a n, Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N   
•  
M e g a n Sc h a ef er, Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N  
•  
Alis o n Mc R a e, M.S . . Divisi o n of G astr o e nt er ol o gy a n d H e p at ol o gy, D e p art m e nt of M e dici n e, M ay o Cli nic, 
R oc h est er, M N   
 
C o nflicts of I nt er est: 
C o nflicts of I nt er est:   n o n e  
 
 
 
 
 
 

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C o nt e nts  
A B S T R A C T:  ............................................................................................................................................................ 3  
I ntr o d ucti o n: ..................................................................................................................................................... 3  
H y p ot h esis: ........................................................................................................................................................ 3  
Ai m:  ................................................................................................................................................................... 3  
St u dy d esi g n:  ..................................................................................................................................................... 3  
St u dy M e dic ati o n:  ............................................................................................................................................. 3  
A ntici p at e d R es ults:  .......................................................................................................................................... 4  
Si g nific a nc e:  ...................................................................................................................................................... 4  
B A C K G R O U N D : ...................................................................................................................................................... 5  
O v ervi e w:  .......................................................................................................................................................... 5  
Pr eli mi n ary D at a:  .............................................................................................................................................. 7  
H y p ot h esis:  ........................................................................................................................................................... 7  
R E S E A R C H PL A N:  ................................................................................................................................................... 7  
D esi g n:  ............................................................................................................................................................... 7  
P artici p a nts:  ...................................................................................................................................................... 8  
M e dic ati o n:  ....................................................................................................................................................... 9  
M et h o ds:  ........................................................................................................................................................... 9  
Pri m ar y E n d p oi nt:  ........................................................................................................................................... 1 4  
St atistic al A n alysis:  .......................................................................................................................................... 1 5  
P O T E N TI AL PI T F ALL S A N D P R E C A U TI O N S T A K E N:  .............................................................................................. 1 5  
A N TI CI P A T E D R E S UL T S A N D SI G NI FI C A N C E:  ....................................................................................................... 1 6  
A P P E N DI X A: Q U E S TI O N N AI R E S  .......................................................................................................................... 1 7  
R E F E R E N C E S:  ....................................................................................................................................................... 5 3  
 
 
 

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A B S T R A C T:  
I ntr od ucti o n :  
O b esity is a c hr o nic, h et er o g e n e o us c o m pl ex dis e as e t h at h as r e ac h e d  e pi d e mic pr o p orti o ns. R ec e ntly, w e 
i d e ntifi e d a n a b n or m al p ost pr a n di al s ati ety o b esity ( A P S-O B) p h e n oty p e c h ar act eriz e d by acc el er at e d g astric 
e m ptyi n g, a n a b n or m al p ost pr a n di al s e ns ati o n of f ull n ess a n d r e d uc e d s ati ety h or m o n es s uc h as GL P 1 a n d P Y Y. 
I n a r ec e nt r a n d o miz e d-cli nic al tri al i n ty p e 2 Di a b et es[ 1], w e s h o w e d t h at il e o-c ol o nic d eliv ery of c o nj u g at e d 
bil e aci ds (I C -C B A S) i m pr ov e s glyc e mi a a n d i ncr e as e s t h e r el e as e of s ati ety h or m o n es. El ev at e d f ec al B ili ary A ci ds 
( B A) w er e als o ass oci at e d t o w ei g ht l oss. H o w ev er, t h e s p ecific eff ect of I C -C B A S i n A PS -O B is u nk n o w n.  
Hy p ot h esis:  
W e hy p ot h esiz e t h at I C -C B A S will sti m ul at e e nt er o e n d ocri n e L c ell ( E E C)  s ecr eti o n of s ati ety h or m o n es 
[Gl uc a g o n Lik e p e pti d e 1 ( GL P -1 ), P e pti d e Tyr osi n e Tyr osi n e 3 -3 6 ( P Y Y 3 -3 6), fi br o bl ast gr o wt h f act or 1 9 (F G F -1 9 ), 
oxy nt o m o d uli n ( O X M) ], i n t h e il e u m a n d c ol o n, i n d uci n g w ei g ht l oss a n d r est ori n g n or m al s ati ety i n p ati e nts wit h 
A PS -O B .  
Ai m:   
T o st u dy t h e eff ect of I C-C B AS o n E E C  f u ncti o n, s ati ety h or m o n es, micr o bi ot a,  a n d  b o dy  w ei g ht  i n p ati e nts wit h 
A PS -O B  p h e n oty p e . 
St u dy d esi g n:  
T his is  a si n gl e -c e nt er, pl ac e b o-c o ntr oll e d, d o u bl e -bli n d e d,  p ar all el -gr o u p, r a n d o miz e d 9 0  d ays ( +/ - 5  d ays) tri al 
t o st u dy t h e eff ect of I C-C B AS  5 0 0 m g a n d 1 0 0 0 m g BI D o n  E E C f u ncti o n,  s ati ety p erc e pti o n, b o dy w ei g ht  a n d 
s ati ety GI h or m o n es, i n p ati e nts wit h A P S -O B p h e n oty p e . A lif estyl e i nt erv e nti o n will b e pr ovi d e d. T h es e c o nsist 
of a n o b esity p hysici a n c o ns ult, a l o w -c al ori e di et i nstr uct e d by a m e m b er of t h e st u dy t e a m , a n d p hysic al activity 
a n d b e h avi or al s u g g esti o ns. T h es e i nt erv e nti o ns s h o ul d l ast at l e ast t h e l e n gt h of t h e st u dy. I n a d diti o n, t his 
st u dy will i ncl u d e 2 c ol o n osc o pi es at t h e b e gi n ni n g (i. e., b ef or e m e dic ati o n/ pl ac e b o st art) a n d at t h e e n d of t h e 
st u dy (i. e., aft er l ast d os e of m e dic ati o n/ pl ac e b o) i n t h e first 6 p ati e nts i n e ac h gr o u p willi n g t o c o ns e nt t o th e 
c ol o n osc o pi es (1 2 p ati e nts; 2 4  c ol o n osc o pi es i n t ot al). P artici p a nts will r ec eiv e a b o w el pr e p ( M ovi -pr e p) a n d 
f oll o w st a n d ar d c ol o n osc o py pr e p ar ati o n g ui d es. T h e n ext d ay, aft er a n ov er ni g ht f asti n g, a c ol o n osc o py wit h 
t er mi n al il e u m i nt u b ati o n will b e p erf or m e d. T h e c ol o n osc o py will b e d o n e i n t h e GI cli nic al or r es e arc h u nit a n d 
will b e s u p p ort e d by s e d ati o n b as e d o n p ati e nts’ c h ar act eristics (i. e., c o nsci o us s e d ati o n vs. a n est h esi a 
s u p p ort e d s e d ati o n). D uri n g t h e pr oc e d ur e, 8 bi o psi es will b e o bt ai n e d fr o m t h e ili u m, ri g ht a n d l eft c ol o n.  W e 
will i ncl u d e ot h er wis e h e alt hy p ati e nts wit h a B MI > 3 0  k g/ m 2, a g e r a n g e 1 8-6 5 y e ars, a n d A P S -O B p h e n oty p e. 
B as e d o n t h e r es ults of o ur pr evi o us tri al c o m p ari n g w ei g ht l oss i n ex e n ati d e t h er a py vs pl ac e b o [ 2], w e 
c alc ul at e d a s a m pl e siz e of 1 8 p artici p a nts p er gr o u p (t ot al of 3 6) wit h 8 0 % p o w er, 0. 0 5 al p h a t o d et ect a 1 k g 
diff er e nc e b et w e e n tr e at m e nt a n d pl ac e b o gr o u ps.   
St u dy I nt erv e nti o n: 
Il e oc ol o nic-r el e as e c o nj u g at e d bil e aci d 5 0 0 m g  t a bl ets will b e pr ovi d e d by Bil ar m H e alt h I nc. , S a n Di e g o, C A. 

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A ntici p at e d R es ults:  
In c o m p aris o n wit h pl ac e b o, I C-C B AS  will  r es ult i n i m pr ove d  E E C f u ncti o n , i ncr e ase d  p ost pr a n di al i ncr eti n  
s ecr eti o n, a n d w ei g ht l oss w h e n c o m p ar e d t o pl ac e b o .  
Si g nific a nc e:  
W e ex p ect t o d e m o nstr at e t h at d el ay e d I C-C B AS i ncr e as es s ati ety, r est ori n g s ati ety i n p ati e nts wit h A PS -O B  
p h e n oty p e . T his st u dy will pr ovi d e t h e b asis f or f ut ur e p h ar m ac ol o gic al st u di es, ex pl ori n g t h e eff ect of l u mi n al 
e nt er o e n d ocri n e s ecr et a g o g u es i n p ati e nts wit h o b esity a n d A P S -O B  p h e n oty p e .  
 
 

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B A C K G R O U N D : 
Ov ervi e w:  
I n 2 0 1 7 – 2 0 1 8, 4 2. 4 % of t h e a d ult p o p ul ati o n  i n t h e US ( ~ 8 8. 6 milli o n) w er e r e p ort e d t o h av e o b esity  a n d,  
9. 2 % h a d  s ev er e o b esity ( ~ 1 9. 2 4 milli o n a d ults). Fr o m 1 9 9 9– 2 0 0 0 t hr o u g h 2 0 1 7 – 2 0 1 8, t h e pr ev al e nc e of 
t his dis e as e i n a d ults i ncr e as e d fr o m 3 0. 5 % t o 4 2. 4 %, i n t h e c as e of s ev er e o b esity  it i ncr e as e d fr o m 4. 7 % 
t o 9. 2 % [ 3]. T h e t ot al a n n u al m e dic al c osts attri b ut a bl e  t o o b esity w er e a p pr oxi m at ely $ 4 8 0  billi o n [ 4]. 
M or e ov er, o b esity  r el at e d c o m plic ati o ns i ncl u d e c or o n ary art ery dis e as e, ty p e II di a b et es, a n d e n d-st a g e 
r e n al dis e as e ( a m o n g ot h ers). S ev er e o b esity i ncr e as es t h e risk of t h es e c o m plic ati o ns ev e n f urt h er [ 3], 
f ost eri n g a d diti o n al ex p e ns es a n d c o m pr o misi n g t h e p o p ul ati o n's h e alt h a n d q u ality of lif e.  O b esity a n d 
s ev er e o b esity h av e b e e n ass oci at e d wit h  i ncr e as e d c ar di ov asc ul ar dis e as e m ort ality. H az ar d r ati os r a n gi n g 
fr o m 1. 2 9 –  2. 2 1 wit h a p < 0. 0 0 1 w er e f o u n d w h e n c ar di ov asc ul ar dis e as e m ort ality w as c o m p ar e d b et w e e n 
s u bj ects wit h B MI > 3 0 a n d s u bj ects wit h n or m al B MIs ( 1 8. 5 -2 4. 9) [ 5]. I n a n ot h er st u dy wit h m or e t h a n 
1 5 0, 0 0 0 p ost m e n o p a us al US w o m e n; t h e h az ar d r ati o f or all -c a us e m ort ality i n w o m e n wit h o b esity a n d 
c e ntr al o b esity c o m p ar e d t o n or m al w o m e n  (a dj ust e d f or d e m o gr a p hics, s oci o ec o n o mic st at u s, lif estyl e 
f act ors a n d h or m o n e us e) w as 1. 3 ( 9 5 % CI: 1. 2 7 -1. 3 4) [ 6]. 
O b esity m ay b e u n d erst o o d si m ply by b al a nci n g e n er gy i nt ak e a n d ex p e n dit ur e. T h e g ut -br ai n axis  pl ays a 
si g nific a nt r ol e i n r e g ul ati n g t h e st a g es of f o o d i nt ak e (i. e., h u n g er, s ati ati o n, a n d s ati ety ). G astric se ns ory 
a n d m ot or fu ncti o ns c o ntri b ut e t o e n er gy int ak e  a n d s erv e t o o bj ectiv ely ass ess t h es e st a g es, i n p artic ul ar 
s ati ati o n a n d s ati ety [ 7]. S ati ety c a n b e q u a ntifi a bly m e as ur e d by vis u al a n al o g sc or e ( V A S) f or a p p etit e a n d 
g astric e m ptyi n g of s oli ds. R es ults of g astric e m ptyi n g st u di es c a n b e s u m m ariz e d i n h alf ti m e T 1/ 2mi n [ 8]. 
N ot o nly  is t h er e a si g nific a nt c orr el ati o n b et w e e n g astric e m ptyi n g a n d a p p etit e s e ns ati o ns , b ut als o a 
c orr el ati o n wit h pr os p ectiv e c al ori e c o ns u m pti o n  [ 9, 1 0]. I n d e e p er a n alysis of p ati e nts wit h a b n or m al s ati ety 
p h e n oty p e, t h er e  is a si g nific a nt l o w er pl as m a l ev els of g astr oi nt esti n al s ati ety h or m o n es ( P Y Y 3 -3 6 a n d  GL P -1) 
w h e n c o m p ar e d t o n or m al p ost pr a n di al s ati ety p artici p a nts wit h o b esity. F urt h er m or e , t h es e s a m e gr o u p of 
p ati e nts h a d d ecr e as e d m R N A ex pr essi o n of P Y Y i n c ol o nic m uc os a c o m p ar e d t o n or m al s ati ety o b esity  
( C al d er o n et al., S u b mitt e d t o C ell R e p orts M e dici n e).   
 
C urr e nt a p pr o ac h es t o tr e at o b esity i ncl u d e di et ary i nt erv e nti o ns, p h ar m ac ol o gic al o pti o ns, e n d osc o pic 
d evic es , a n d s ur g ery. D es pit e t h e a dv e nt of o b esity t h er a pi es,  r es p o ns e t o tr e at m e nt still s h o ws hi g h i nt er-
i n divi d u al v ari a bility. C o ns e q u e ntly, t h e s e gr e g ati o n a n d cl assific ati o n of t h e s p ecific tr aits t h at l e a d t o t h e 
p at h o p hysi ol o gy of o b esity ar e  i m p er ativ e t o att e m pt a g ui d e d, effici e nt,  a n d i n divi d u aliz e d t h er a py  [ 8]. I n 
2 0 1 5 , w e s h o w e d q u a ntit ativ e c h ar act eriz ati o n of p ati e nts wit h o b esity b as e d o n  g astr oi nt esti n al a n d 
psyc h ol o gic al tr aits [ 2]. F urt h er m or e, i n pr o of of c o nc e pt si n gl e-c e nt er, r a n d o miz e d, pl ac e b o -c o ntr oll e d 
tri als wit h m e dic ati o n ( e. g., p h e nt er mi n e/t o pir a m at e, ex e n ati d e, lir a gl uti d e) a n d e n d osc o pic pr oc e d ur es 
( e. g., I ntr a g astric B all o o n, en d osc o pic sl e ev e g astr o pl ast y) o b esity -r el at e d p h e n oty p es pr e dict e d r es p o ns e 
t o tr e at m e nt [ 2, 1 1-1 6] . Fi n ally, in a r e al -w orl d pr a g m atic tri al, t h e p h e n oty p e g ui d e d t h er a py w h e n 

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c o m p ar e d t o n o n -p h e n oty p e -g ui d e d r es ult e d i n 1. 7 5 -f ol d gr e at er w ei g ht l oss aft er 1 2 m o nt hs wit h m e a n 
w ei g ht l oss of 1 5. 9 % c o m p ar e d wit h 9. 0 % i n t h e n o n -p h e n oty p e -g ui d e d gr o u p a n d t h e pr o p orti o n of 
p ati e nts w h o l ost > 1 0 % at 1 2 m o nt hs w as 7 9 % i n t h e p h e n oty p e -g ui d e d gr o u p vs. 3 4 % i n n o n -p h e n oty p e -
g ui d e d tr e at m e nt gr o u p  [ 8]. 
O n e of t h e a f or e m e nti o n e d f o o d-i nt ak e r e g ul ati n g m ec h a nis ms is th e bil e aci d p at h w ay . I C-C B A S  h as b e e n 
i d e ntifi e d i n ex viv o  m o d els  as a s ecr et a g o g u e f or E E C , i n d uci n g i ncr eti n ( GL P-1) s ecr eti o n [ 1]. Bil e aci ds ( B As) 
circ ul at e t hr o u g h a c o m pl ex p at h w ay t h at r e g ul at es t h eir sy nt h esis, s ecr eti o n, circ ul ati o n, r e a bs or pti o n, a n d 
excr eti o n. T h es e st er oi d -d eriv e d d et er g e nt m ol ec ul es f or m mic ell es f acilit ati n g c h ol est er ol a bs or pti o n t hr o u g h 
t h e br us h b or d er m e m br a n e of t h e s m all i nt esti n e. T h e a pic al N a +-d e p e n d e nt bil e s alt tr a ns p ort er ( A S B T) 
m e di at es t h e activ e B As tr a ns p ort i n  t h e dist al il e u m [ 1 7]. T his pr oc ess r es ults i n 9 5 % r e u pt ak e of B As t h at e nt er 
t h e s m all i nt esti n e [ 1 8, 1 9]; t h e v ast m aj ority of r e m ai ni n g n on -r e a bs or b e d B As u n d er g o d ec o nj u g ati o n a n d 
d e hy dr oxyl ati o n by c ol o nic b act eri a i nt o s ec o n d ary B A s, pri or t o excr eti o n i n t h e st o ols. P assiv e c ol o nic 
r e a bs or pti o n of bil e aci ds r ec ov ers s o m e of t h e 5 % r e m ai ni n g bil e s alts  [ 2 0]. At t his l ev el, r e a bs or b e d B As act as 
e n d o g e n o us li g a n ds f or f ar n es oi d X r ec e pt ors ( F X R) a n d G pr ot ei n c o u pl e d bil e aci d r ec e pt or 5 ( G P B A R 1 or T G R 5) 
i n t h e e nt er ocyt e [ 1 8]. T h es e t w o r ec e pt ors ar e sti m ul at e d i ntr ac ell ul arly, i n d uci n g pr o d ucti o n of fi br o bl ast 
gr o wt h f act or 1 9 (F GF -1 9) a n d g l uc a g o n-lik e p e pti d e 1 ( GL P - 1) , r es p ectiv ely. F GF-1 9 is a bil e aci d p at h w ay 
m ark er w h os e pri m ary f u ncti o n is t o g e n er at e n e g ativ e f e e d b ack i nt o t h e h e p at ocyt es d ecr e asi n g t h e sy nt h esis 
of B As [ 2 1].  
I n o ur pr ev i o us st u dy, T G R 5 w as o bs erv e d i n h u m a n c ol o nic m uc os al bi o psi es t h at w er e als o GL P -1 p ositiv e [ 1].  
T h e s a m e st u dy s h o w e d i ncr e as e d i ncr eti n m R N A ex pr essi o n a n d GL P -1 r el e as e w h e n c ol o n ocyt es w er e 
sti m ul at e d ex -viv o wit h t a ur oc h olic aci d [ 1]. T h er e w as d ecr e as e d F GF -1 9 i n p ati e nts wit h o b esity a n d di a b et es 
w h e n c o m p ar e d wit h  c o ntr ols, as w ell as  w h e n dist al E EL w er e sti m ul at e d wit h c o nj u g at e d bil e aci d a n d  
c o m p ar e d t o pl ac e b o [ 1]. Sti m ul ati o n of T G R 5 r es ults i n a r a pi d i ncr e as e i n i ncr eti ns, r e d uc e d a p p etit e, a n d 
i m pr ov e m e nt i n i ns uli n s e nsitivity [ 2 2, 2 3]. T h e d eliv er y of bil e aci ds t o t h e dist al il e u m a n d c ol o n h a d  p ositiv e 
eff ects o n gl uc os e m et a b olis m  i n o ur pr evi o us st u dy [ 1], i ncr e as e d l ev els of f ec al B A w er e  als o ass oci at e d wit h 
w ei g ht l oss  i n it. 
W e b eli ev e t h es e eff ects c a n b e s e e n aft er m et a b olic s ur g ery, w h er e bil e aci d s ecr eti o n i ncr e as es si g nific a ntly 
aft er R o ux -i n-Y g astric by p ass s ur g ery. R ec e nt st u di es s h o w e d c ol o n ocyt es ex pr ess B A si g n ali n g m ac hi n ery  a n d  
d efici e ncy of s ai d m ac hi n ery i n p ati e nts wit h o b esity a n d di a b et es . I n h u m a ns, t h e ac ut e i nf usi o n of t a ur oc h olic 
bil e aci d e n e m as p er r ect u m or vi a n as oj ej u n al f e e di n g r es ult e d i n r a pi d i ncr e as e i n GI s ati ety h or m o n es a n d 
i ncr e as e d s ati ety [ 2 4, 2 5]. B il e aci ds n e e d t o b e d eliv er e d t o t h e dist al il e u m a n d c ol o n t o sti m ul at e o nly dist al L-
c ells a n d av oi d pr oxi m al li pi d a bs or pti o n . T h us, it is critic al t o k n o w, w h et h er t h e d eliv ery of I C-C B A S  will r est or e 
t h e n or m al s ati ety i n p ati e nts wit h  AS P -O B . W e hy p ot h esiz e  t h at t h e I C-C B AS  d eliv er y will sti m ul at e E E C s ecr eti o n 
i n t h e dist al j ej u n u m, il e u m, a n d c ol o n, t h er e by i ncr e asi n g t h e s ecr eti o n of GL P-1 a n d P Y Y 3 -3 6. T his will possi bly 
r est ore  s ati ety a n d i n d uc e w ei g ht l oss  i n A P S -O B p h e n oty p e  s u bj ects.  
T h e ov er all r es e arc h g o al is t o st u dy t h e eff ect of d el ay e d -r el e as e I C-C B A S  o n s ati ety  a n d b o dy w ei g ht  i n A P S -O B  
p h e n oty p e p ati e nts w h e n c o m p ari n g it t o pl ac e b o. T h e c urr e nt pr o p os al is a pr o of of c o nc e pt, si n gl e c e nt er, 
pl ac e b o -c o ntr oll e d, r a n d o miz e d cli nic al tri al i n ot h er wis e h e alt hy p ati e nts wit h o b esity a n d a b n or m al s ati ety. 

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will r ec eiv e a b o w el pr e p ( M ovi -pr e p) a n d f oll o w st a n d ar d c ol o n osc o py pr e p ar ati o n g ui d es. T h e n ext d ay, aft er 
a n ov er ni g ht f asti n g, a c ol o n osc o py wit h t er mi n al il e u m i nt u b ati o n will b e p erf or m e d. T h e c ol o n osc o py will b e 
d o n e i n t h e GI cli nic al or r es e arc h u nit a n d will b e s u p p ort e d by s e d ati o n b as e d o n p ati e nts’ c h ar act eristics (i. e., 
c o nsci o us s e d ati o n vs. a n est h esi a s u p p ort e d s e d ati o n). D uri n g t h e pr oc e d ur e, 8 bi o psi es will b e o bt ai n e d fr o m 
t h e ili u m, ri g ht a n d l eft c ol o n. D uri n g t h e St u dy T e a m visits, p ati e nts will m e et wit h t h e st u dy t e a m t o r evi e w 
m e dic ati o n c o m pli a nc e, ass ess a dv ers e ev e nts, a n d p erf or m a m e dic ati o n dis p e ns ati o n.  
 T h e c li nic al r es e arc h t e a m will p erf or m a m e dic al r ec or d r evi e w t o ac q uir e p ossi bl e c a n di d at es f or r ecr uit m e nt . 
T h e r a n d o miz ati o n sc h e m e will b e pr ovi d e d by t h e st u dy bi ost atistici a n .  All oc ati o n will b e c o nc e al e d.  P h ar m acy 
will pr ovi d e t h e m e dic ati o n or pl ac e b o.  R a n d o miz ati o n will b e str atifi e d i n s ex-s p ecific t ertil es (l o w, m e di u m, 
hi g h) d efi n e d by  g astric e m ptyi n g ( T 1/ 2, mi n).  
 
P artici p a nts:   
S u bj ects wit h o b esity a n d a b n or m al s ati ety  p h e n oty p e  will b e r ecr uit e d by dir ect c o nt act fr o m a n est a blis h e d 
d at a b as e of p ati e nts or by p u blic a dv ertis e m e nt , i ncl u di n g s oci al m e di a.  All s u bj ects will b e giv e n a v er b al 
ex pl a n ati o n of t h e st u dy, pr ovi d e d ti m e t o r e a d a n d st u dy t h e writt e n c o ns e nt f or m a n d its i nf or m ati o n, a n d 
giv e n o p p ort u niti es t o ask q u esti o ns a n d c o py t h e c o ns e nt f or m.   P artici p a nts will b e i nf or m e d of t h eir ri g ht t o 
wit h dr a w fr o m t h e st u dy at a ny ti m e wit h o ut pr ej u dic e t o t h eir cli nic al m a n a g e m e nt n o w or i n t h e f ut ur e. 
C o ns e nt will b e s o u g ht by o n e of t h e m e dic al d oct or i nv esti g at ors or st u dy c o or di n at or s, a n d c o ns e nt will b e 
d oc u m e nt e d by t h e p artici p a nt’s si g n at ur e o n t h e c o ns e nt f or m  virt u ally or i n p ers o n . All r ecr uit m e nt or c o nt act 
i nf or m ati o n will b e a p pr ov e d by M ay o's I nstit uti o n al R evi e w B o ar d. 
 
Incl usi o n
ncl usi o n  crit eri a
crit eri a:  
I. 
P ati e nts wit h o b esit y  B MI > 3 0 k g/ m 2 a n d  h u n gr y g ut p h e n ot y p e . 
II. 
A g e: 1 8 -6 5 y e ars. 
III. 
G e n d er: m e n or w o m e n. W o m e n of c hil d b e ari n g p ot e nti al will h av e a n e g ativ e pr e g n a ncy t est b ef or e 
i niti ati o n of m e dic ati o n a n d wit hi n 4 8 h o urs of r ec eivi n g r a di ois ot o p e f or t h e g astric e m ptyi n g st u dy.   
I V. 
Ot h er wis e h e alt hy i n divi d u als  or wit h c o ntr oll e d c hr o nic m e dic al c o n diti o ns s uc h as ty p e 2 
di a b et es.  
 
E xcl usi o n
xcl usi o n crit eri a
crit eri a:  
I. Str uct ur al or 
m et a b olic dis e as es/c o n diti o ns t h at aff ect t h e g astr oi nt esti n al syst e m, or f u ncti o n al 
g astr oi nt esti n al dis or d ers. F or scr e e ni n g t h e b o w el dis e as e q u esti o n n air e will b e us e d t o excl u d e s u bj ects 
wit h irrit a bl e b o w el sy n dr o m e.  
II. S u bj ects wit h st o ol ty p e Brist ol cl assific ati o n 6 -7 p er b o w el dis e as e q u esti o n n air e .  

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III. F e m al e s u bj ects w h o ar e pr e g n a nt or br e ast -f e e di n g.  
I V. U s e of a nti -o b esity m e dic ati o ns u p o n scr e e ni n g  (i e., orlist at , p h e nt er mi n e -t o pir a m at e, lir a gl uti d e, 
s e m a gl uti d e, b u pr o pi o n -n altr ex o n e ), m etf or mi n or GL P-1 a n al o gs.  
V. I n divi d u als w h o ar e c urr e ntly o n tr e at m e nt f or u nst a bl e c ar di ac, p ul m o n ary, g astr oi nt esti n al, h e p atic, 
r e n al, h e m at ol o gic al, n e ur ol o gic al, e n d ocri n e,  a n d psyc hi atric  dis e as e.   
VI. A ny ac ut e or c hr o nic c o n diti o n or ot h er dis e as e t h at, i n t h e o pi ni o n of t h e I nv esti g at or, w o ul d li mit t h e 
s u bj ect’s a bility t o c o m pl et e a n d/ or p artici p at e i n t his cli nic al st u dy.  
VII . Si g nific a nt u ntr e at e d psyc hi atric dysf u ncti o n b as e d u p o n scr e e ni n g. H os pit al A nxi ety a n d D e pr essi o n 
I nv e nt ory ( H A D) sc or e > 1 1 o n d e pr essi o n sc al e , a s elf-a d mi nist er e d alc o h olis m scr e e ni n g t est ( A U DI T -C) 
sc or e > 4 i n m e n or > 3 i n w o m e n, a n d diffic ulti es wit h s u bst a nc e or e ati n g dis or d ers d et er mi n e d by t h e  
Q u esti o n n air e o n E ati n g a n d W ei g ht P att er ns ( bi n g e e ati n g dis or d ers a n d b uli mi a) ; will m e a n t h e 
p artici p a nt will b e excl u d e d a n d giv e n a r ef err al l ett er t o his/ h er pri m ary c ar e d oct or f or f urt h er a p pr ais al 
a n d f oll o w -u p. T h e pr ovi d er will r evi e w t h e p ati e nt’s alc o h ol i nt ak e ov er t h e p ast f e w m o nt hs t o c o nfir m 
acc ur acy a n d d et er mi n e st u dy eli gi bili ty. 
VII. Pri nci p al I nv esti g at or discr eti o n.  
I nt erv e nti o n: 
C B A S  5 0 0  m g t a bl ets will b e s u p pli e d by Bil ar m H e alt h I nc. . S u bj ects will t ak e m e dic ati o n or pl ac e b o or ally t wic e 
d aily o n a n e m pty st o m ac h, 3 0 mi n ut es pri or t o br e akf ast a n d ev e ni n g di n n er f or 9 0  +/ - 5  d ays. P ati e nts o n t h e 
m e dic ati o n will r ec eiv e 5 0 0 m g t wic e d aily d uri n g t h eir first w e ek a n d 1 0 0 0 m g  t wic e d aily f or t h e r est of t h e 
st u dy.  
 
M et h o ds : 
P artici p a nts will k e e p f o o d, a p p etit e,  a n d activity di ari es f or o n e w e ek pri or t o b as eli n e t est  d ay [ 1 1]. O n 
r a n d o miz ati o n d ay t h ey will als o r ec eiv e t h e r a n d o miz e d m e dic ati o n ( d el ay e d r el e as e I C-C B A S  or  pl ac e b o ). A f ull 
m e dic al hist ory a n d p hysic al ex a m will b e p erf or m e d a n d r ec or d e d, a n d  a l o w -c al ori e di et will b e s u g g est e d 
d uri n g t his visit .  
O n D ay 9 0  ( +/- 5  d ays), s u bj ects will r e p e at o b esity p h e n oty pi n g pr ot oc ol  at t h e exit visit  [ 1 1] as d escri b e d 
pr evi o usly b ut will r ec eiv e t h e st u dy m e dic ati o n/ pl ac e b o 3 0 mi n ut es pri or t o t h e t est m e al.    
 
 

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V ersi o n 3. 0  
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1 0  
 
 
* Visit 1, 3, 4 a n d 6 c a n  b e c o n d uct e d at t h e Cli nic al R es e arc h a n d Tri als U nit ( C R T U)i n t h e 
 
at M ay o Cli nic i n R oc h est er, M N.  
Visit 2 a n d 5 c a n b e c o n d uct e d at t h e C R T U or o n 
 
 
Scr e e ni n g a n d C o ns e nt
Scr e e ni n g a n d C o ns e nt  (virt u al)
(virt u al): 
D uri n g t h e scr e e ni n g a n d c o ns e nt visit, i nf or m e d c o ns e nt will b e r e q u est e d eit h er i n p ers o n or virt u ally t hr o u g h 
t h e e-c o ns e nt pr oc ess. W e will r e q u est m e dic al hist ory,  or p erf or m a bri ef c h art r evi e w  if av ail a bl e, ac q uir e m ost 
r ec e nt a nt hr o p o m etric p ar a m et ers, (h ei g ht, w ei g ht, a n d w aist circ u mf er e nc e ) a n d w e will r e q u est  c o m pl eti o n 
of q u esti o n n air es ( A p p e n dix A) . T h e q u esti o n n air es  will b e a d mi nist er e d vi a R e dc a p a n d  will n e e d t o b e fill e d 
aft er c o ns e nti n g t o d et er mi n e eli gi bility. F o o d  a n d activity di ari es will b e giv e n t o t h e p artici p a nts f or filli n g d uri n g 
t h e f oll o wi n g 7 d ays ( b as eli n e a n d tr e at m e nt p h as e). A n activity tr acki n g d evic e will als o b e giv e n t o b e us e d 
t hr o u g h o ut t h e c o m pl et e st u dy. A st o ol c oll ecti o n kit b e pr ovi d e d  t o c o m pl et e 4 8 h o urs pri or t o visit 1.  
S e e a p p e n dix A: Q u esti o n n air es
S e e a p p e n dix A: Q u esti o n n air es  
Scr e e ni n g  & p h e n oty pi n g  q u esti o n n air es:  
1.  GI Scr e e ni n g B o w el Dis e as e Q u esti o n n air e  
2.  H os pit al A nxi ety a n d D e pr essi o n I nv e nt ory  
3.  Brist ol st o ol sc al e  
4.  P hysic al Activity Q u esti o n n air e  
5.  E ati n g P att er ns Q u esti o n n air e  
6.  B o dy S elf R el ati o ns Q u esti o n n air e  

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7.  A u dit C Q u esti o n n air e  
8.  W ei g ht M a n a g e m e nt Q u esti o n n air e  
9.  O b esity Q u esti o n n air e   
1 0.  Ex ercis e R e g ul ati o ns ( B R E Q -3) Q u esti o n n air e(s urv ey)  
1 1.  B arri ers t o B ei n g Activ e Q u esti o n n air e(s urv ey)  
1 2.  W ei g ht Effic acy Q u esti o n n air e(s urv ey)                                                                                                 
1 3.  T hr e e F act or E ati n g ( T F E Q -R 2 1) Q u esti o n n air e(s urv ey)  
1 4.  P hysic al Ex a m a n d Hist ory D oc u m e nt ati o n  
 
 
B as eli n e 
B as eli n e p h e n oty p
p h e n oty p e : 
S u bj ects will c oll ect a r a n d o m st o ol s p eci m e n 4 8 h o urs b ef or e visit  1 . All t h e p artici p a nts  will  b e giv e n a n  activity  
tr acki n g d evic e . T his d evic e  n e e ds t o b e pick e d u p i n t h e C R T U, al o n gsi d e wit h t h e  i nstr ucti o ns o n h o w t o i nst all 
it wit h  its c orr es p o n di n g tr acki n g a p p. T h ey will b e r e q uir e d t o us e t his d evic e d uri n g t h e ti m e t h ey ar e 
p artici p ati n g i n t h e st u dy . P hysic al activity d at a , c al oric c o ns u m pti o n a n d m e dic ati o n us e will b e e nt er e d by t h e 
p artici p a nts  vi a w e ekly di ari es , a s w ell as extr acti n g p hysic al activity d at a fr o m e ac h p artici p a nt’s tr acki n g d evic e 
acc o u nt . A f o o d  di ary will als o b e giv e n t o all p artici p a nts t o fill i n t h e w e ek pri or d uri n g t his w e ek. All 
q u esti o n n air es will b e s e nt  a n d fill e d d uri n g t his 7 -d ay  p eri o d i n c as e t h ey di d n ’t c o m pl et e t h e m d uri n g t h e 
scr e e ni n g a n d c o ns e nt.  
 
•  
Visit 
Visit 1 : B as eli n e p h e n oty p e  
P artici p a nts will att e n d M ay o Cli nic Cli nic al R es e arc h Tri al U nit ( C R T U) at 
 
 
 R oc h est er 
M N aft er a n 8 -h o ur f asti n g p eri o d.  
- 
T h e y will u n d er g o  a nt hr o p o m etric m e as ur e m e nts:  
H ei g ht, w ei g ht, bl o o d pr ess ur e, h e art a n d r es pir at ory r at es, w aist a n d hi p r ati o, w aist circ u mf er e nc e, 
a n d t e m p er at ur e.  
B as eli n e a n d f oll o w-u p  c h ar act eristics st u di es:  
- 
M et h o ds of m et a b olic st u di es : 
o  
B o dy c o m p ositi o n will b e m e as ur e d by D E X A ( d u al e n er gy x -r ay a bs or pti o m etry).  
o  
R esti n g e n er gy ex p e n dit ur e w as ass ess e d by i n dir ect c al ori m etry wit h a v e ntil at e d h o o d ( P arv o 
M e dics, S a n dy, U T).  

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1 2  
 
o  
G astric e m ptyi n g ( G E) of s oli ds by sci nti gr a p hy  [ 9] [ 8, 1 1]I m a g es will b e ac q uir e d at 0, 3 0, 6 0, 
9 0, 1 2 0 a n d 2 4 0 mi n ut es f oll o wi n g t h e n or m al cli nic al g astric e m ptyi n g t esti n g pr ot oc ol wit h o ut 
a p us h m e al.  
o  
S ati ati o n 
will b e 
m e as ur e d  by a d -li bit u m m e al t o 
m e as ur e t ot al c al oric i nt ak e a n d 
m acr o n utri e nt distri b uti o n i n t h e c h os e n f o o d. S ati ati o n will b e r e p ort e d i n c al ori es c o ns u m e d 
at f ull n ess (s ati ati o n) [ 8] [ 1 1]. 
o  
A p p etit e  s e ns ati o ns by vis u al a n al o g sc or e f asti n g a n d ev ery 3 0 mi n ut es aft er t h e st a n d ar d m e al 
f or G E a n d t h e S ati ati o n t est u p t o 2 h o urs [ 8, 1 1]. 
o  
Bl o o d  s a m pl es: T h e f asti n g bl o o d s a m pl es will b e c oll ect e d d uri n g t h e g astric e m ptyi n g m e al 
a n d st or e d at -7 0° C fr e ez er. W e will a n alyz e pl as m a gl uc os e, i ns uli n, C -p e pti d e, GL P -1, P Y Y 3 -3 6, 
O X M, F G F -1 9, 7 -α -C 4, A di p o n ecti n, L e pti n, C C K, P a ncr e atic P oly p e pti d e ( P P) , s er u m bil e aci ds, 
s h ort c h ai n f atty aci ds, a mi n o aci ds[ 2, 8]. S a m pl es c oll ecti o n, h a n dli n g, a n d st or a g e: S a m pl es 
will b e c oll ect e d aft er a n ov er ni g ht f ast ( of at l e ast 8 h o urs) i n t h e m or ni n g. Pl as m a will b e 
pr es erv e d f oll o wi n g st a n d ar d g ui d eli n es a n d pr ot ei n d e gr a d ati o n i n hi bit ors, k a llikr ei n a n d D P P-
I V i n hi bit ors will b e a d d e d t o pr es erv e t h e s a m pl es. S a m pl es will b e st or e d at -8 0º C i n t h e PI’s 
l a b or at ory. Pl as m a h or m o n es a n d pr ot e o mics by r a di oi m m u n o ass ay a n d/ or m ass s p ectr o m etry 
m e as ur e d f asti n g, p ost pr a n di al , a n d ev ery 3 0 mi n ut es f or 6 h o urs. T h e pri m ary e n d p oi nt b ei n g 
t h e p e ak p ost pr a n di al l ev el (t est s h o ul d b e d o n e si m ult a n e o usly t o G E).  
o  
Bl o o d D N A f or g e n o m e wi d e ass oci ati o n st u di es ( G W AS) . T h es e s a m pl es will b e st or e d f or 
f ut ur e r es e arc h.  
o  
St o ol s a m pl es: O n e r a n d o m st o ol will b e c oll ect e d at b as eli n e a n d aft er tr e at m e nt f or f ec al bil e 
aci ds, s h ort c h ai ns f atty aci ds a n d micr o bi o m e.  
o  
P artici p a nts wit h c hil d b e ari n g p ot e nti al will u n d er g o a pr e g n a ncy t est . 
o  
S elf -a d mi nist er e d q u esti o n n air es ass essi n g aff ect, p hysic al activity l ev els, attit u d es, b o dy 
i m a g e, di et, a n d e ati n g b e h avi or; d et ails of e ac h q u esti o n n air e ar e pr ovi d e d b el o w.  
▪ 
H os pit al A nxi ety a n d D e pr essi o n Sc al e: H A DS will b e us e d t o scr e e n f or s ev er e a nxi ety 
or d e pr essi o n.  
▪ 
A U DI T -C Alc o h olis m Scr e e ni n g T est [ 2 6] - T h e A U DI T -C is a 3 -it e m alc o h ol scr e e ni n g 
q u esti o n n air e t h at r eli a bly i d e ntifi es p artici p a nts w h o ar e h az ar d o us alc o h ol dri nk ers 
or h av e activ e alc o h ol us e dis or d ers. T his sc or e will b e us e d i n scr e e ni n g by t h e st u dy 
p hysici a n/ n urs e c o or di n at or. T h e A U D I T-C is sc or e d o n a sc al e of 0 -1 2. E ac h A U DI T -C 
q u esti o n h as 5 a ns w er c h oic es. P oi nts all ott e d ar e: a = 0 p oi nts; b = 1 p oi nt; c = 2 p oi nts; 
d = 3 p oi nts; e = 4 p oi nts. I n m e n, a sc or e of 4 or m or e is c o nsi d er e d p ositiv e, o pti m al f or 
i d e ntifyi n g h az ar d o us dri nki n g or activ e alc o h ol us e dis or d ers. I n w o m e n, a sc or e of 3 
or m or e is c o nsi d er e d p ositiv e (s a m e as a b ov e).   
▪ 
E ati n g Dis or d ers Q u esti o n n air e - T h e Q u esti o n n air e o n E ati n g a n d W ei g ht P att er ns -
R evis e d  [ 2 7], is a v ali d m e as ur e of scr e e ni n g f or e ati n g dis or d ers w hic h h as b e e n us e d 
i n s ev er al n ati o n al m ulti-sit e fi el d tri als. R es p o n d e nts ar e cl assifi e d as bi n g e e ati n g 
dis or d er, p ur gi n g b uli mi a n erv os a, n o n -p ur gi n g b uli mi a n erv os a, or a n or exi a n erv os a. 
W e h av e us e d t his i nstr u m e nt t o scr e e n f or e ati n g dis or d ers i n o b es e p o p ul ati o ns.  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 3  
 
▪ 
T hr e e F act or e ati n g q u esti o n n air e is 2 1 -it e m q u esti o n n air e, v ali d at e d, t o ass ess f or 
e m oti o n al e ati n g dis or d ers a n d f o o d cr avi n gs.  
▪ 
P hysic al Activity L ev el - T h e f o ur -it e m P hysic al Activity St a g es of C h a n g e Q u esti o n n air e 
will b e utiliz e d t o ass ess t h e p hysic al activity l ev el of p artici p a nts. 
M ay o Cli nic 
i nv esti g at ors, l e d by c o-i nv esti g at or Dr. Cl ark, h av e us e d t h es e it e ms t o ex pl or e t h e 
r el ati o ns hi p b et w e e n q u ality of lif e a n d p hysic al activity i n a n N CI-f u n d e d st u dy o n 
lo n g -t er m l u n g c a nc er s urviv ors . P hysic al Activity L ev el - T h e f o ur -it e m P hysic al Activity 
St a g es of C h a n g e Q u esti o n n air e  [ 2 8] will b e utiliz e d t o ass ess t h e p hysic al activity l ev el 
of p artici p a nts. M ay o Cli nic i nv esti g at ors, l e d by c o -i nv esti g at or Dr. Cl ark, h av e us e d 
t h es e it e ms t o ex pl or e t h e r el ati o ns hi p b et w e e n q u ality of lif e a n d p hysic al activity i n 
a n N CI -f u n d e d st u dy o n l o n g-t er m l u n g c a nc er s urviv ors [ 2 8]. 
 
- 
Lif estyl e i nt erv e nti o n a n d b e h avi or al tr e at m e nt :  
All p artici p a nts will m e et wit h a st u dy p hysici a n as st a n d ar d of c ar e i n cli nic al pr actic e.  All p artici p a nts 
will g ui d e d t o 1) Di et: R e d uc e di et ary i nt ak e b el o w t h at r e q uir e d f or e n er gy b al a nc e by c o ns u mi n g 1 2 0 0  
c al ori es p er d ay f or w o m e n a n d 1 4 0 0  c al ori es p er d ay f or m e n; 2) P hysic al Activity: r e ac h t h e g o al of 
1 0, 0 0 0 st e ps or m or e p er d ay; 3) Ex ercis e: r e ac h t h e g o al of 1 5 0 mi n ut es or m or e of c ar di ov asc ul ar 
ex ercis e/ w e ek; 4) Li mit c o ns u m pti o n of li q ui d c al ori es (i. e. s o d as, j uic es, alc o h ol, etc.).   
 
 
 
- 
Visit 2: C ol o n osc o py # 1
Visit 2: C ol o n osc o py # 1  a n d R a n d o miz ati o n
a n d R a n d o miz ati o n  
o  
Visit 2 will o nly b e c o m pl et e d i n t h e first 6 p ati e nts of e ac h gr o u p w h o ar e willi n g t o c o ns e nt t o 
b ot h c ol o n osc o py visits.  
o  
Visit 2  will occ ur 3 - 5 d ays of Visit 1 . P artici p a nts will r ec eiv e a b o w el pr e p ( M ovi-pr e p) d uri n g 
V isit 1  a n d f oll o w st a n d ar d c ol o n osc o py pr e p ar ati o n g ui d es. T h e n ext d ay, aft er a n ov er ni g ht 
f asti n g, a c ol o n osc o py wit h t er mi n al il e u m i nt u b ati o n will b e p erf or m e d. T h e c ol o n osc o py will 
b e d o n e i n t h e GI cli nic al or r es e arc h u nit a n d will b e s u p p ort e d by s e d ati o n b as e d o n p ati e nts’ 
c h ar act eristics (i. e., c o nsci o us s e d ati o n vs. a n est h esi a s u p p ort e d s e d ati o n). D uri n g t h e 
pr oc e d ur e, 8 bi o psi es will b e o bt ai n e d fr o m t h e ili u m, ri g ht a n d l eft c ol o n.  
 
o  
R a n d o miz ati o n  a n d tr e at m e nt :  
R a n d o miz ati o n will b e p erf or m e d by t h e r es e arc h p h ar m acy u p o n n otific ati o n by t h e st u dy c o or di n at or . 
Tr e at m e nts will b e all oc at e d at a 1: 1 r ati o str atifi e d wit hi n l o w, m e di u m, or hi g h g astric e m ptyi n g ( T 1/ 2) 
r at es, b as e d o n s ex-s p ecific t hr es h ol ds. T h e str atific ati o n gr o u p will b e d et er mi n e d by t h e st u dy 
c o or di n at or a n d c o m m u nic at e d t o t h e p h ar m acist. A c o m p ut er a p plic ati o n will pr ovi d e t h e r a n d o miz e d 
assi g n m e nt b as e d o n a r a n d o miz ati o n sc h e d ul e cr e at e d by t h e st u dy st atistici a n. O nly t h e st u dy 
st atistici a n will h av e acc ess t o t h e c o m pl et e sc h e d ul e. Ot h er st u dy p ers o n n el a n d t h e s u bj ect will b e 
bli n d e d t o assi g n e d tr e at m e nt.  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 4  
 
P ati e nts will r ec eiv e st u dy m e dic ati o n ( activ e or pl ac e b o ), a n d t h ey will b e giv e n v er b al i nstr ucti o ns o n 
h o w t h ey s h o ul d t ak e t h eir m e dic ati o ns . S u bj ects will t ak e m e dic ati o n or pl ac e b o or ally t wic e d aily o n 
a n e m pty st o m ac h, 3 0 mi n ut es pri or t o br e akf ast a n d ev e ni n g di n n er f or 9 0  (+/ - 5)  d ays. P ati e nts will 
b e i nstr uct e d t o st art t h e m e dic ati o n aft er visit 2 (c ol o n osc o py).  
 
•  
Visit 3: St u dy T e a m 
Visit 3: St u dy T e a m visit
visit 
o  
P artici p a nts will m e et wit h t h e st u dy t e a m  ( eit h er i n p ers o n at t h e C R T U or  virt u ally) 
a p pr oxi m at ely 3 0 d ays aft er visit 2. T h e st u dy t e a m will ass ess a dv ers e ev e nts, m e dic ati o n 
c o m pli a nc e, a n d p erf or m a n e w m e dic ati o n dis p e ns ati o n  (if visit is virt u al t h e m e dic ati o n will 
b e s hi p p e d t o t h e p artici p a nt’s pr ef err e d a d dr ess) .   
 
•  
Visit 4:
Visit 4:     St u dy T e a m visit
St u dy T e a m visit  
P artici p a nts will m e et wit h t h e st u dy t e a m ( eit h er i n p ers o n at t h e C R T U or virt u ally) a p pr oxi m at ely 3 0 d ays aft er 
visit 3 . T h e st u dy t e a m will ass ess a dv ers e ev e nts, m e dic ati o n c o m pli a nc e, a n d p erf or m a n e w m e dic ati o n 
dis p e ns ati o n  (if visit is virt u al t h e m e dic ati o n will b e s hi p p e d t o t h e p artici p a nt’s pr ef err e d a d dr ess).  .   
•  
Visit 
Visit 5 : C ol o n osc o py # 2
: C ol o n osc o py # 2 
o  
Visit 5  will o nly b e c o m pl et e d i n t h e first 6 p ati e nts of e ac h gr o u p w h o ar e willi n g t o c o ns e nt t o 
b ot h c ol o n osc o py visits . 
o  
P artici p a nts will r ec eiv e a b o w el pr e p ( M ovi -pr e p) d uri n g visit 5  a n d f oll o w st a n d ar d 
c ol o n osc o py pr e p ar ati o n g ui d es. T h e n ext d ay, aft er a n ov er ni g ht f asti n g, a c ol o n osc o py wit h 
t er mi n al il e u m i nt u b ati o n will b e p erf or m e d. T h e c ol o n osc o py will b e d o n e i n t h e GI cli nic al or 
r es e arc h u nit a n d will b e s u p p ort e d by s e d ati on b as e d o n p ati e nts’ c h ar act eristics (i. e., 
c o nsci o us s e d ati o n vs. a n est h esi a s u p p ort e d s e d ati o n). D uri n g t h e pr oc e d ur e, 8 bi o psi es will 
b e o bt ai n e d fr o m t h e ili u m, ri g ht a n d l eft c ol o n.  
- 
Visit 
Visit 6  –  Exit P h e n oty pi n g
Exit P h e n oty pi n g  
o  
Visit 6  will occ ur wit hi n 7  d ays of Visit 3 . P h e n oty pi n g w ill b e p erf or m e d  as at t h e b as eli n e 
p h e n oty pi n g visit  i ncl u di n g t h e q u esti o n n air es p erf or m e d i n scr e e ni n g visit.  
 
 
Pri m ary E n d p oi nt:  
 T h e pri m ary e n d p oi nt is  E E C f u ncti o n m e as ur e d t hr o u g h s ati ety h or m o n e s’ ( GL P-1 & P Y Y A U C a n d a bs ol ut e 
pl as m a v al u e c urv es ) co m p aris o n b et w e e n i nt erv e nti o n a n d pl ac e b o gr o u ps at d ay 9 0  i n A P S -O B  p h e n oty p e 
p artici p a nts.  
S ec o n d ar y E n d p oi nt:  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 5  
 
Ev al u ati o n of  o b esity p h e n oty p es t hr o u g h g astric e m ptyi n g T ½ f or s oli ds, sati ety s e ns ati o n wit h a vis u al a n al o g u e 
sc al e ( V A S), f ull n ess ( V AS), h u n g er ( V AS), d esir e t o e at ( V A S), a p p etit e ov er all sc or e ( V A S), a d -li bitu m b uff et m e al 
f o o d i nt ak e (kc al), micr o bi al c h a n g es, b e h avi or al q u esti o n n air es, e n er gy ex p e n dit ur e , a n d b o dy w ei g ht i n A P S -
O B p h e n oty p e p artici p a nts i nt erv e n e d wit h I C-C B AS , c o m p ar e d t o pl ac e b o.  
St atistic al A n alysis :    
T h e pri m ary a n alysis will c o m p ar e  A U C, v al u es b et w e e n tr e at m e nt a n d pl ac e b o gr o u ps aft er  9 0  d ays of I C -C B A S.  
B as e d o n t h e pr evi o us st u dy by C al d er o n et al. [ 1], w e c alc ul at e d a s a m pl e siz e of 3 6 s u bj ects. T h ey r e p ort e d GL P-
1 A U C si g nific a nt diff er e nc e b et w e e n i nt erv e nti o n a n d pl ac e b o gr o u p of 3 2 2 3 m g/ dl. W e ai m t o d et ect a m e a n 
diff er e nc e i n A U C of 3 2 2 3 m g/ dl a n d utiliz e d t h eir I Q R t o c alc ul at e a st a n d ar d d evi ati o n of 3 1 2 5 m g/ dl.  T o h av e 
8 0 % p o w er t o d et ect a diff er e nc e of 3 2 2 3 m g/ dl wit h a t w o -s a m pl e t-t est w o ul d r e q uir e 1 2  s u bj ects p er gr o u p. 
I n or d er t o all o w f or u p t o 3 0 % dr o p o ut, w e will e nr oll 3 6 s u bj ects t ot al.   T h e eff ect o n w ei g ht l oss will b e 
ev al u at e d  usi n g a n alysis of c ov ari a nc e ( A N C O V A) m o d els , wit h r el ativ e w ei g ht l oss as t h e d e p e n d e nt v ari a bl e, 
a dj usti n g f or g astric e m ptyi n g ( T 1/ 2, mi n) a n d g e n d er.  A ny p o w er l ost o n d e gr e es of fr e e d o m s p e nt o n c ov ari at e 
p ar a m et er esti m ati o n s h o ul d b e m or e t h a n r ecl ai m e d by r e d uc e d err or v ari ati o n. F or t h e r est of t h e e n d p oi nts  
w e will c o m p ar e t h e d at a o n g astric e m ptyi n g , s ati ati o n p ar a m et ers, a p p etit e sc or es,  b o dy c o m p ositi o n, e n er gy 
ex p e n dit ur e, GI h or m o n es , bil e aci ds  a n d micr o bi ot a  b et w e e n i nt erv e nti o n vs. pl ac e b o, usi n g t h e s a m e A N C O V A 
m o d el . Tr a nsf or m ati o ns will b e e m pl oy e d as n e e d e d f or h e avily sk e w e d distri b uti o ns. All tr e at m e nt eff ect 
esti m at es will b e r e p ort e d wit h 9 5 % c o nfi d e nc e i nt erv als.  
 
P O T E N TI AL PI T F ALL S A N D P R E C A U TI O NS T A K E N : 
 
P ot e nti al pitf alls 
P ot e nti al pitf alls of mi n or si g nific a nc e  i n t his st u dy ar e:  
- S el ecti o n bi as
S el ecti o n bi as  - P artici p a nts willi n g t o p artici p at e will lik ely b e m or e m otiv at e d t o l os e w ei g ht  t h a n t h e g e n er al 
p o p ul ati o n . R a n d o miz ati o n, d o u bl e bli n d will av oi d a ny s el ecti o n bi as;  
- P ot e nti al f or ty p e II err or
P ot e nti al f or ty p e II err or  - T h e s a m pl e siz es h av e b e e n b as e d o n a p pr o pri at e st atistic al p o w er  wit h all o w a nc e 
f or dr o p o ut. Esti m at es  of v ari ati o n h a v e b e e n t h or o u g hly c h ar act eriz e d i n t h e pri or lit er at ur e fr o m o ur l a b; a n d 
ot h er i nt er n al a n d ext er n al st u di es f or w ei g ht l oss at 1 2 w e eks.  
- F e asi bility
F e asi bility  - W e h av e i d e ntifi e d a c o h ort of p e o pl e i n o ur c o m m u nity w h o h av e o b esity,  a b n or m al s ati ety  
p h e n oty p e , a n d ar e willi n g t o p artici p at e. W e h av e t h e ex p eri e nc e t o s ucc essf ully r ecr uit 3 6  p artici p a nts  f or t h e 
st u dy.  
H u m a n St u di es As p ects 
H u m a n St u di es As p ects  
A dv ers e Eff ects of M e dic ati o ns
A dv ers e Eff ects of M e dic ati o ns : T a ur oc h olic  aci d is us e d f or g all bl a d d er st o n es diss ol uti o n a n d pr ev e nti o n 
as a n utr ac e utic al a n d f o o d s u p pl e m e nt. It is ass oci at e d wit h t h e f oll o wi n g p ot e nti al a dv ers e eff ects: n a us e a, 
di arr h e a, a n or exi a, hy p ers e nsitivity.   T h es e ar e i ncl u d e d i n t h e c o ns e nt f or m.  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 6  
 
R a di ati o n ex p os ur e: 
R a di ati o n ex p os ur e: i n t his st u dy c o m es fr o m t h e 9 9 mTc us e d t o m e as ur e g ut tr a nsit. T h es e ex p os ur es 
c o nf or m t o pr evi o usly a p pr ov e d l ev els of r a di ati o n ex p os ur e a p pr ov e d by t h e R a di ati o n C o ntr ol C o m mitt e e at 
M ay o Cli nic. T h e r a di ati o n d osi m etry a n d or g a n ex p os ur es (i n mr a d) ar e mi ni m al. S e e D osi m etry T a bl e
S e e D osi m etry T a bl e  i n 
i n 
a p p e n dix A
a p p e n dix A  
A N TI CI P A T E D R E S UL T S A N D SI G NI FI C A N C E :  
W e ex p ect t o d e m o nstr at e t h at 
I C-C B A S r est or es s ati ety i n o b esity  h u n gry g ut  p h e n oty p e  p ati e nts,  
e n h a nci n g il e o c ol o nic E E C  f u ncti o n a n d s u bs e q u e ntly i n d uci n g w ei g ht lo ss. T his st u dy will pr ovi d e t h e b asis f or 
l ar g er tri als t esti n g B A  as  p h ar m ac ol o gic al  o pti o ns i n p ati e nt p h e n oty p e t ail or e d tr e at m e nt f or o b esity.   
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 7  
 
A P P E N DI X A: Q U E S TI O N N AI R ES  
B o w el Dis e as e Q u esti o n n air e  
I n t h e p ast 1 2 m o nt hs, h a v e y o u ex p eri e nc e d t h e f oll o wi n g ? 
Q U E S TI O N
Q U E S TI O N  
Y E S
Y E S  
N O
N O  
1.  2 or l ess t h a n 2 b o w el m ov e m e nts/ w e ek  
 
 
2.  Exc essiv e str ai ni n g or s e ns ati o n of i nc o m pl et e ev ac u ati o n of st o ol o n m or e 
t h a n 2 5 % of occ asi o ns 
 
 
3.  L u m py st o ols o n m or e t h a n 2 5 % of occ asi o ns 
 
 
At l e ast 3 m o nt hs of c o nti n u o us or r ec urr e nt sy m pt o ms of:  
4.  A b d o mi n al p ai n or disc o mf ort r eli ev e d by d ef ec ati o n  
5.  A b d o mi n al p ai n or disc o mf ort ass oci at e d wit h a c h a n g e i n st o ol fr e q u e ncy  
6.  A b d o mi n al p ai n or disc o mf ort ass oci at e d wit h a c h a n g e i n st o ol c o nsist e ncy  
 
 
 
 
 
 
7.  M or e t h a n 3 b o w el m ov e m e nts p er d ay  
 
 
8.  L o os e w at ery st o ols 
 
 
9.  Bl o ati n g  
 
 
1 0.  S w all o wi n g diffic ulti es  
 
 
1 1.  U p p er a b d o mi n al p ai n aft er m e als m or e t h a n o nc e a m o nt h  
 
 
1 2.  A b d o mi n al bl o ati n g aft er m e als  
 
 
1 3.  N a us e a r e g ul arly m or e t h a n o nc e a m o nt h  
 
 
1 4.  V o miti n g r e g ul arly m or e t h a n o nc e a m o nt h  
 
 
1 5.  H e art b ur n r e g ul arly m or e t h a n o nc e a w e ek  
 
 
1 6.  Aci d r efl ux r e g ul arly m or e t h a n o nc e a w e ek 
 
 
Si g n _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 8  
 
T h e H os pit al A nxi et y a n d D e pr essi o n Q u esti o n n air e  
Pl e as e r e a d e ac h it e m a n d circl e
circl e t h e r e ply w hic h b est d escri b es h o w y o u h av e b e e n f e eli n g d uri n g t h e p ast w e ek.  D o n’t 
d ev ot e t o o m uc h ti m e t o y o ur r es p o ns es; y o ur i m m e di at e r e acti o n will pr o b a bly b e m or e acc ur at e t h a n a l o n g t h o u g ht o ut 
r es p o ns e. 
1.  
I f e el t e ns e or ‘ w o u n d u p’ : 
- 
M ost of t h e ti m e  
- 
A l ot of t h e ti m e  
- 
Occ asi o n ally  
- 
N ot at all  
 
2.  
I still e nj oy t h e t hi n gs I us e d t o e nj oy : 
- 
D efi nit ely as m uc h  
- 
N ot q uit e s o m uc h  
- 
O nly a littl e  
- 
H ar dly at all  
 
3.  
I g et a fri g ht e n e d f e eli n g, as if s o m et hi n g a wf ul is 
a b o ut t o h a p p e n :  
- 
V ery d efi nit ely a n d q uit e b a dly  
- 
Y es, b ut n ot t o o b a dly  
- 
A littl e, b ut it d o es n’t w orry m e  
- 
N ot at all  
 
4.  
I c a n l a u g h a n d s e e t h e f u n ny si d e of t hi n gs : 
- 
As m uc h as I al w ays c o ul d  
- 
N ot q uit e s o m uc h n o w  
- 
D efi nit ely n ot s o m uc h n o w  
- 
N ot at all  
 
5.  
W orryi n g t h o u g hts g o t hr o u g h my mi n d :  
- 
A gr e at d e al of t h e ti m e  
- 
A l ot of t h e ti m e  
- 
Fr o m ti m e t o ti m e  
- 
O nly occ asi o n ally  
 
6.  
I f e el c h e erf ul : 
- 
N ot at all  
- 
N ot oft e n  
- 
S o m eti m es  
- 
M ost of t h e ti m e  
 
7.  
I c a n sit at e as e a n d f e el r el ax e d : 
- 
D efi nit ely  
- 
Us u ally  
- 
N ot oft e n  
- 
N ot at all  
 
8.  
I f e el as if I a m sl o w e d d o w n : 
- 
N e arly all t h e ti m e  
- 
V ery oft e n  
- 
S o m eti m es  
- 
N ot at all  
 
9.  
I g et a fri g ht e n e d f e eli n g, lik e ‘ b utt erfli es i n t h e 
st o m ac h’ : 
- 
N ot at all  
- 
Occ asi o n ally  
- 
Q uit e oft e n  
- 
V ery oft e n  
 
1 0.   I h av e l ost i nt er est i n my a p p e ar a nc e : 
- 
D efi nit ely  
- 
I d o n’t t ak e as m uc h c ar e as I s h o ul d 
- 
I m ay n ot t ak e q uit e as m uc h c ar e 
- 
I t ak e j ust as m uc h c ar e as ev er 
 
1 1.  I f e el r estl ess as if I h av e t o b e o n t h e m ov e : 
- 
V ery m uc h i n d e e d  
- 
Q uit e a l ot  
- 
N ot v ery m uc h  
- 
N ot at all  
 
1 2.  I l o ok f or w ar d wit h e nj oy m e nt t o t hi n gs : 
- 
As m uc h as I ev er di d  
- 
R at h er l ess t h a n I us e d t o  
- 
D efi nit ely l ess t h a n I us e d t o  
- 
H ar dly at all  
 
1 3.  I g et s u d d e n f e eli n gs of p a nic : 
- 
V ery oft e n i n d e e d  
- 
Q uit e oft e n  
- 
N ot v ery oft e n  
- 
N ot at all  
 
1 4.  I c a n e nj oy a g o o d b o ok or T V pr o gr a m : 
- 
Oft e n  
- 
S o m eti m es  
- 
N ot oft e n  
- 
V ery s el d o m  
 
Si g n _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
1 9  
 
Brist ol St o ol Sc al e  
Circl e t h e f or m w hic h b est d escri b es y o ur n or m al b o w el m ov e m e nts.  
E as e of P ass a g e:
E as e of P ass a g e:  
 1.1.   M a n u al disi m p acti o n r e q uir e d  
 2.2.   E n e m a or s u p p osit ory r e q uir e d t o i niti at e b o w el m ov e m e nt  
 3.3.   S o m e str ai ni n g n ec ess ary t o p ass b o w el m ov e m e nt  
 4.4.   E asy n or m al p ass a g e of st o ol wit h o ut str ai ni n g  
 5.5.   Ur g e nt n e e d t o p ass b o w el m ov e m e nt s p o nt a n e o usly; n o
n o  a b d o mi n al p ai n or disc o mf ort pr es e nt  
 6.6.   Ur g e nt n e e d t o p ass b o w el m ov e m e nt s p o nt a n e o usly; a b d o mi n al p ai n or cr a m pi n g pr es e nt  
 7.7.   I nc o nti n e nt of b o w el m ov e m e nts 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 0  
 
P h ysic al Activity St a g es of C h a n g e Q u esti o n n air e  
F or e ac h of t h e q u esti o ns b el o w, pl e as e c h eck Y es or N o.  Pl e as e b e s ur e t o f oll o w t h e 
i nstr ucti o ns c ar ef ully. 
 
P hysic al activity or ex ercis e i ncl u d es activiti es s uc h as w alki n g briskly, j o g gi n g, bicycli n g, s wi m mi n g or a ny ot h er 
activity w h er e t h e ex erti o n is as l e ast as h ar d as t h es e activiti es.  Y o ur h e art r at e a n d br e at hi n g s h o ul d 
i ncr e as e. 
 
N O  
Y E S  
1. I a m c urr e ntly p hysic ally activ e
p hysic ally activ e  
 
 
2. I i nt e n d t o b ec o m e m or e p hysic ally activ e
p hysic ally activ e  i n t h e n ext 6 m o nt hs 
 
 
 
F or activity t o b e r e g ul ar
r e g ul ar, it m ust a d d u p t o a t ot al
t ot al of 3 0 mi n ut es or m or e p er d ay
3 0 mi n ut es or m or e p er d ay , a n d b e d o n e at l e ast 5 d ays 
at l e ast 5 d ays 
p er w e ek
p er w e ek .  F or ex a m pl e, y o u c o ul d t ak e o n e 3 0 mi n ut e w alk, or t ak e t hr e e 1 0 mi n ut e w alks e ac h d ay.   
 
 
N O  
Y E S  
3. I c urr e ntly e n g a g e i n r e g ul ar p hysic al activity
r e g ul ar p hysic al activity 
 
 
4. I  h av e b e e n r e g ul arly 
r e g ul arly p hysic ally activ e
p hysic ally activ e  f or t h e p ast 6 m o nt hs 
 
 
 
 
Si g n :_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e :_ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 1  
 
E ati n g P att er ns Q u esti o n n air e
E ati n g P att er ns Q u esti o n n air e  
 
 
 
 
_ _ 
_ _ 1 5 
1.  D uri n g t h e p ast six
six m o nt hs, di d y o u oft e n e at wit hi n a ny t w o -h o ur p eri o d w h at m ost p e o pl e w o ul d 
r e g ar d as a n u n us u ally l ar g e a m o u nt of f o o d ? 
1
  Y es                0
 N o   → S KI P T O Q U E S TI O N 5  
 
 
 
_ _ 
_ _ 1 6 
2.  D uri n g t h e ti m es w h e n y o u at e t his w ay, di d y o u oft e n f e el y o u c o ul d n’t st o p e ati n g or c o ntr ol w h at or 
h o w m uc h y o u w er e e ati n g ?  
1
  Y es                0
 N o   → S KI P T O Q U E S TI O N 5  
 
3.  D uri n g t h e p ast six
six m o nt hs, h o w oft e n, o n av er a g e, di d y o u h av e ti m es w h e n y o u at e t his w ay –  t h at is, 
l ar g e a m o u nts of f o o d pl us
pl us  t h e f e eli n g t h at y o ur e ati n g w as o ut of c o ntr ol (t h er e m ay h av e b e e n s o m e 
w e eks w h e n it w as n ot pr es e nt –  j ust av er a g e t h os e i n).  
_ _ 
_ _ 1 7 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
     3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 N e arly ev ery d ay  
 
4.  Di d y o u us u ally h av e a ny of t h e f oll o wi n g ex p eri e nc es d uri n g t h es e occ asi o ns ?  
_ _ 
_ _ 1 8  
a. E ati n g m uc h m or e r a pi dly t h a n us u al ?                       1
  Y es                0
 N o    
_ _ 
_ _ 1 9  
b. E ati n g u ntil y o u f elt u nc o mf ort a bly f ull ?                  1
  Y es                0
 N o    
 
_ _ 
_ _ 2 0  
c.  E ati n g l ar g e a m o u nts of f o o d w h e n y o u di d n’t  
f e el p hysic ally h u n gry ?                                                       1
  Y es                0
 N o    
 
_ _ 
_ _ 2 1  
d.  E ati n g al o n e b ec a us e y o u w er e e m b arr ass e d  
     by h o w m uc h y o u w er e e ati n g ?                                        1
  Y es                0
 N o    
 
_ _ 
_ _ 2 2  
e.  F e eli n g dis g ust e d wit h y o urs elf, d e pr ess e d,  
     or f e eli n g v ery g uilty aft er ov er e ati n g ?                         1
  Y es                0
 N o    
 
5.  I n g e n er al, d uri n g t h e p ast six
six m o nt hs, h o w u ps et w er e y o u by ov er e ati n g ( e ati n g m or e t h a n y o u t hi nk is 
b est f or y o u ) ? 
_ _ 
_ _ 2 3 
1
 N ot at all  
2
 Sli g htly  
     3
 M o d er at ely  
4
 Gr e atly  
5
 Extr e m ely  
 
6.  I n g e n er al, d uri n g t h e p ast six
six m o nt hs, h o w u ps et w er e y o u by t h e f e eli n g t h at y o u c o ul d n’t st o p e ati n g 
or c o ntr ol w h at or h o w m uc h y o u w er e e ati n g ?  
_ _ 
_ _ 2 4 
1
 N ot at all  
2
 Sli g htly  
     3
 M o d er at ely  
4
 Gr e atly  
5
 Extr e m ely  
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 2  
 
 
7.  D uri n g t h e p ast six m o nt hs, h o w i m p ort a nt h as y o ur w ei g ht or s h a p e b e e n, i n h o w y o u f e el a b o ut or 
ev al u at e y o urs elf as a p ers o n –  as c o m p ar e d t o ot h er as p ects of y o ur lif e, s uc h as h o w y o u d o at w ork as 
a p ar e nt, or h o w y o u g et al o n g wit h ot h er p e o pl e ?  
_ _ 
_ _ 2 5 
1
 W ei g ht a n d s h a p e w er e n ot v ery i m p ort a nt
n ot v ery i m p ort a nt  
2
 W ei g ht a n d s h a p e pl ay e d a p art 
pl ay e d a p art i n h o w y o u f elt a b o ut y o urs elf 
3
 W ei g ht a n d s h a p e w er e a m o n g t h e m ai n t hi n gs
w er e a m o n g t h e m ai n t hi n gs  t h at aff ect e d h o w y o u f elt a b o ut y o urs elf 
4
 W ei g ht a n d s h a p e w er e t h e m ost i m p ort a nt t hi n gs
w er e t h e m ost i m p ort a nt t hi n gs  t h at aff ect e d h o w y o u f elt a b o ut y o urs elf 
 
8.  D uri n g t h e p ast t hr e e
t hr e e m o nt hs, di d y o u ev er m ak e y o urs elf v o mit i n or d er t o av oi d g ai ni n g w ei g ht aft er 
bi n g e e ati n g ?  
_ _ 2 6 
_ _ 2 7 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 M or e t h a n fiv e ti m es a w e ek  
 
 
 
 
9.  D uri n g t h e p ast t hr e e
t hr e e m o nt hs, di d y o u ev er t ak e m or e t h a n t wic e t h e r ec o m m e n d e d d os e of l ax ativ es i n 
or d er t o av oi d g ai ni n g w ei g ht aft er bi n g e e ati n g ?  
_ _ 2 7  
_ _ 2 8 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 M or e t h a n fiv e ti m es a w e ek  
 
 
 
 
1 0.  D uri n g t h e p ast t hr e e m o nt hs, di d y o u ev er t ak e m or e t h a n t wic e t h e r ec o m m e n d e d d os e of di ur etics 
( w at er pills) i n or d er t o av oi d g ai ni n g w ei g ht aft er bi n g e e ati n g ?  
_ _ 2 9 
_ _ 3 0 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 M or e t h a n fiv e ti m es a w e ek  
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 3  
 
 
1 1.  D uri n g t h e p ast t hr e e m o nt hs, di d y o u ev er f ast –  n ot e at a nyt hi n g at all f or at l e ast 2 4 h o urs --i n or d er 
t o av oi d g ai ni n g w ei g ht aft er bi n g e e ati n g ? 
_ _ 3 1 
_ _ 3 2 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 N e arly ev ery d ay  
 
 
 
 
1 2.  D uri n g t h e p ast t hr e e m o nt hs, di d y o u ev er ex ercis e f or m or e t h a n a n h o ur s p ecific ally
s p ecific ally i n or d er t o av oi d 
g ai ni n g w ei g ht aft er bi n g e e ati n g ?  
_ _ 3 3 
_ _ 3 4 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 M or e t h a n fiv e ti m es a w e ek  
 
 
 
 
1 3.  D uri n g t h e p ast t hr e e m o nt hs, di d y o u ev er t ak e m or e t h a n t wic e t h e r ec o m m e n d e d d os e of a di et pill 
i n or d er t o av oi d g ai ni n g w ei g ht aft er bi n g e e ati n g ?  
_ _ 3 5 
_ _ 3 6 
1
 Y es ⎯⎯→ 
0
 N o    
 
 
 
H o w oft e n,  o n av er a g e
o n av er a g e , w as t h at ? 
1
 L ess t h a n o n e d ay a w e ek 
2
 O n e d ay a w e ek  
3
 T w o or t hr e e d ays a w e ek  
4
 F o ur t o fiv e ti m es a w e ek  
5
 M or e t h a n fiv e ti m es a w e ek  
 
 
 
 
 
 
 
 
 
Si g n _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 4  
 
M ulti -di m e nsi o n al B o dy -S elf R el ati o ns Q u esti o n n air e ( M B S R Q)  
 
 
O n a sc al e of 1 (v ery diss atisfi e d) t o 5 (v ery s atisfi e d) pl e as e i n dic at e h o w 
O n a sc al e of 1 (v ery diss atisfi e d) t o 5 (v ery s atisfi e d) pl e as e i n dic at e h o w  
s atisfi e d y o u ar e wit h e ac h of t h e f oll o wi n g ar e as or as p ects of y o ur b o dy:
s atisfi e d y o u ar e wit h e ac h of t h e f oll o wi n g ar e as or as p ects of y o ur b o dy: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
V ery 
V ery 
diss atisfi e d
diss atisfi e d  
M ostly
M ostly  
diss atisfi e d
diss atisfi e d  
N eit h er 
N eit h er 
s atisfi e d n or 
s atisfi e d n or 
diss atisfi e d
diss atisfi e d  
 
M ostly 
M ostly 
s atisfi e d
s atisfi e d 
V ery 
V ery 
s atisfi e d
s atisfi e d 
  
1. F ac e (f aci al f e at ur es, c o m pl exi o n)  
 
1
 
2
 
3
 
4
 
5
 
  
2. H air (c ol or, t hick n ess, t ext ur e)  
 
1
 
2
 
3
 
4
 
5
 
 
3  L o w er t ors o ( b utt ocks, hi ps, t hi g hs, l e gs)  
 
1
 
2
 
3
 
4
 
5
 
 
4. Mi d t ors o ( w aist, st o m ac h)  
 
1
 
2
 
3
 
4
 
5
 
 
5. U p p er t ors o (c h est or br e asts, s h o ul d ers, 
ar ms)  
 
1
 
2
 
3
 
4
 
5
 
 
6.  M uscl e t o n e  
 
1
 
2
 
3
 
4
 
5
 
 
7. W ei g ht  
 
1
 
2
 
3
 
4
 
5
 
 
8. H ei g ht  
 
1
 
2
 
3
 
4
 
5
 
 
9. Ov er all a p p e ar a nc e  
 
1
 
2
 
3
 
4
 
5
 
 
 
 
Si g n _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 5  
 
E F F E C T O F I L E O C O LI C -R E L E A S E C O N J U G A T E D BI L E 
A CI D O N S A TI E T Y A N D E N T E R O -E N D O C RI N E C E L L 
F U N C TI O N I N P A TI E N T S WI T H O B E SI T Y A N D A B N O R M A L 
S A TI E T Y P H E N O T Y P E  
 
I R B #  
 
 
 
 
F o o d Di ar y  
 
 
Diet: N or m al Diet, B aseli ne  
 
 
 
 
Dates: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  t o _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
 
A n dres Ac ost a C ar de n as, M D,  
Pri nci pal I n vesti gat or  
 
S h a w n a Fr a n ks  
  
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 6  
 
F O O D I N T A K E DI A R Y –  B aseli ne  
C o m plete every d ay. Ret ur n t o M ay o Cli nic o n visit 1.  
 
•  
Please rec or d y o ur f o o d , me dicati o ns a n d be vera ge i nta ke e ver y d a y , i n t he ta ble bel o w. 
•  
Rec or d e v er yt hi n g  y o u eat! F or e x a m ple, if y o u a d d s u gar t o y o ur c offee or eat a bite -size d ca n d y, y o u still 
ha v e t o rec or d t hese ite ms.  
•  
Ma ke s ure t o i ncl u de a m o u nt of f o o d c o ns u me d. (e xa m ple: 8 oz c offee, 2 t bs p pea n ut b utter, 1 c u p w hite 
rice, 1 2 oz stea k wit h 2 t bs p stea k sa uce, 2 slices w heat brea d wit h 1 slice a merica n c heese, 3 pieces of 
sala mi, a n d 1 ts p ma y o n naise.)  
•  
If eati n g at a resta ura nt or eati n g pre pac ka ge d f o o d i ncl u de na me of resta ura nt/f o o d bra n d, ite m 
or dere d/eate n, a n d a m o u nt c o ns u me d .  
•  
If eati n g at a resta ura nt or eati n g pre pac ka ge d f o o d als o i ncl u de cal ories per ser vi n g a n d ser vi n gs  
c o ns u me d . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 7  
 
 
 
 
D a y 1  
 
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 8  
 
 
 
 
D a y 2   
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _         
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
2 9  
 
 
 
D a y 3   
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
3 0  
 
 
 
 
D a y 4   
 
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _         
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
3 1  
 
 
 
D a y 5   
 
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
3 2  
 
 
D a y 6   
 
 
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
3 3  
 
 
D a y 7   
   
 
 
 
 
 
 
Date _ _ _ _ _ _ _ _ _ _ _ _   
 
 
 
 
 
 
 
 
Partici pa nt’s Si g nat ure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
M e al
I nt a k e
N ot e s 
Di n n er
Ot h er
Br e a kf a st
L u n c h
A M S n a c k   
(if a n y)
P M S n a c k   
(if a n y)

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P a g e 1  

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3 7  
 
 

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V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
 
 
 

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3 9  
 
D osi m etry p er a d mi nistr ati o n  
 
 
 
 
 
 
 
 
 
 
 
 

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Dir ecti o ns:  A ns w er e ac h q u esti o n a b o ut h o w y o u ar e f e eli n g b y dr a wi n g a v ertic al m ar k ( |) at t h e 
a p pr o pri at e p oi nt t hr o u g h t h e h oriz o nt al li n e of e ac h q u esti o n.  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I a m  
c o m pl et el y  
e m pt y  
N ot at all f ull  
N ot hi n g at all  
I h a v e n e v er  
b e e n m or e h u n gr y  
 
H o w m uc h d o y o u t hi n k y o u c a n e at ?  
H o w s atisfi e d d o y o u f e el ?  
H o w h u n gr y d o  y o u f e el ? 
H o w f ull d o y o u f e el ?  
I a m n ot  
h u n gr y at all  
I c a n n ot e at  
a n ot h er bit e  
 
T ot all y f ull  
 
A l ot  
 
0 Mi n ut e  
Y es, v er y m uc h  
W o ul d y o u li k e t o e at s o m et hi n g f att y ? 
 
W o ul d y o u li k e t o e at s o m et hi n g s a v o u r y ? 
W o ul d y o u li k e t o e at s o m et hi n g s alt y ?  
W o ul d y o u li k e t o e at s o m et hi n g s w e et ?  
Y es, v er y m uc h  
 
Y es, v er y m uc h  
 
Y es, v er y m uc h  
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
4 1  
 
 
 
 
 
Dir ecti o ns:  A ns w er e ac h q u esti o n a b o ut h o w y o u ar e f e eli n g b y dr a wi n g a v ertic al m ar k ( |) at t h e 
a p pr o pri at e p oi nt t hr o u g h t h e h oriz o nt al li n e of e ac h q u esti o n.  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 0 Mi n ut e  
I a m  
c o m pl et el y  
e m pt y  
N ot at all f ull  
N ot hi n g at all  
I h a v e n e v er  
b e e n m or e h u n gr y  
 
H o w m uc h d o y o u t hi n k y o u c a n e at ?  
H o w s atisfi e d d o y o u f e el ?  
H o w h u n gr y d o  y o u f e el ? 
H o w f ull d o y o u f e el ?  
I a m n ot  
h u n gr y at all  
I c a n n ot e at  
a n ot h er bit e  
 
T ot all y f ull  
 
A l ot  
 
Y es, v er y m uc h  
W o ul d y o u li k e t o e at s o m et hi n g f att y ?  
 
W o ul d y o u li k e t o e at s o m et hi n g s a v o u r y ? 
W o ul d y o u li k e t o e at s o m et hi n g s alt y ? 
W o ul d y o u li k e t o e at s o m et hi n g s w e et ?  
Y es, v er y m uc h  
 
Y es, v er y m uc h  
 
Y es, v er y m uc h  
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
4 2  
 
 
 
 
 
Dir ecti o ns:  A ns w er e ac h q u esti o n a b o ut h o w y o u ar e f e eli n g b y dr a wi n g a v ertic al m ar k ( |) at t h e a p pr o pri at e 
p oi nt t hr o u g h t h e h oriz o nt al li n e of e ac h q u esti o n.  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 0  Mi n ut e  
I a m  
c o m pl et el y  
e m pt y  
N ot at all f ull  
N ot hi n g at all  
I h a v e n e v er  
b e e n m or e h u n gr y  
 
H o w m uc h d o y o u t hi n k y o u c a n e at ?  
H o w s atisfi e d d o y o u f e el ?  
H o w h u n gr y d o  y o u f e el ? 
H o w f ull d o y o u f e el ?  
I a m n ot  
h u n gr y at all  
I c a n n ot e at  
a n ot h er bit e  
 
T ot all y f ull  
 
A l ot 
 
Y es, v er y m uc h  
W o ul d y o u li k e t o e at s o m et hi n g f att y ?  
 
W o ul d y o u li k e t o e at s o m et hi n g s a v o u r y ? 
W o ul d y o u li k e t o e at s o m et hi n g s alt y ?  
W o ul d y o u li k e t o e at s o m et hi n g s w e et ?  
Y es, v er y m uc h  
 
Y es, v er y m uc h  
 
Y es, v er y m uc h  
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
4 3  
 
 
 
 
Dir ecti o ns:  A ns w er e ac h q u esti o n a b o ut h o w y o u ar e f e eli n g b y dr a wi n g a v ertic al m ar k ( |) at t h e a p pr o pri at e 
p oi nt t hr o u g h t h e h oriz o nt al li n e of e ac h q u esti o n.  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 0  Mi n ut e  
I a m  
c o m pl et el y  
e m pt y  
N ot at all f ull  
N ot hi n g at all  
I h a v e n e v er  
b e e n m or e h u n gr y  
 
H o w m uc h d o y o u t hi n k y o u c a n e at ?  
H o w s atisfi e d d o y o u f e el ?  
H o w h u n gr y d o  y o u f e el ? 
H o w f ull d o y o u f e el ?  
I a m n ot  
h u n gr y at all  
I c a n n ot e at  
a n ot h er bit e  
 
T ot all y f ull  
 
A l ot  
 
Y es, v er y m uc h  
W o ul d y o u li k e t o e at s o m et hi n g f att y ?  
 
W o ul d y o u li k e t o e at s o m et hi n g s a v o u r y ? 
W o ul d y o u li k e t o e at s o m et hi n g s alt y ?  
W o ul d y o u li k e t o e at s o m et hi n g s w e et ?  
Y es, v er y m uc h  
 
Y es, v er y m uc h  
 
Y es, v er y m uc h  
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
4 4  
 
 
 
Dir ecti o ns:  A ns w er e ac h q u esti o n a b o ut h o w y o u ar e f e eli n g b y dr a wi n g a v ertic al m ar k ( |) at t h e a p pr o pri at e 
p oi nt t hr o u g h t h e h oriz o nt al li n e of e ac h q u esti o n.  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 2 0  Mi n ut e  
I a m  
c o m pl et el y  
e m pt y  
N ot at all f ull  
N ot hi n g at all  
I h a v e n e v er  
b e e n m or e h u n gr y  
 
H o w m uc h d o y o u t hi n k y o u c a n e at ?  
H o w s atisfi e d d o y o u f e el ?  
H o w h u n gr y d o  y o u f e el ? 
H o w f ull d o y o u f e el ?  
I a m n ot  
h u n gr y at all  
I c a n n ot e at  
a n ot h er bit e  
 
T ot all y f ull  
 
A l ot  
 
Y es, v er y m uc h  
W o ul d y o u li k e t o e at s o m et hi n g f att y ? 
 
W o ul d y o u li k e t o e at s o m et hi n g s a v o u r y ? 
W o ul d y o u li k e t o e at s o m et hi n g s alt y ?  
W o ul d y o u li k e t o e at s o m et hi n g s w e et ?  
Y es, v er y m uc h  
 
Y es, v er y m uc h  
 
Y es, v er y m uc h  
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
N o, n ot at all  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4 5  
 
O B E SI T Y –  Q U E S TI O N N AI R E  
B y: A n dr e s A c o st a  
 
1.  C urr e nt b o d y w ei g ht:  
2.  W ei g ht at gr a d u ati o n of hi g h sc h o ol:  
3.  A n y p artic ul ar ev e nt  t h at pr o d uc e d si g nific a nt w ei g ht g ai n ? ( ex a m pl e: pr e g n a ncy, m e dic ati o ns)  
4.  A n y p artic ul ar r e as o n f or w ei g ht g ai n ?  
5.  Hist ory of o b esit y i n t h e f a mily ?  
6.  N u m b er of c al ori es c o ns u m e d p er d a y:  
7.  T y p e of m acr o n utri e nt di et ( Hi g h pr ot ei n, hi g h c ar b di et):  
8.  C o ns u m pti o n of s o d as:  
•  
If y es, n u m b er p er d ay  
9.  C o ns u m pti o n of artifici al s w e et e n ers:  
•  
If y es, n u m b er p er d ay a n d w hic h ty p e 
1 0.  C o ns u m pti o n of alc o h ol:  
•  
If y es h o w m a n y b ev er a g es p er d ay  
1 1.  D o y o u ev er dri nk m or e t h a n f o ur alc o h olic b ev er a g es i n o n e sitti n g ?  
1 2.  Hist ory of s m oki n g:  Y es or n o  
•  
If y es, h o w m a ny ci g ar ett es p er d ay  
1 3.  H o w l o n g h a v e y o u b e e n s m oki n g  
1 4.  A n y ot h er r ecr e ati o n al dr u gs?  
1 5.  D o y o u ex ercis e ?  
1 6.  H o w m a ny ti m es p er w e e k ?  
1 7.  H o w m a ny mi n ut es p er s essi o n ?  
1 8.  D escri b e y o ur ty pic al w e e k of ex ercis e  
1 9.  D escri b e t h e ex ercis e y o u di d t his p ast w e e k.  
2 0.  W h at t y p es of ex ercis e d o y o u d o ?  
2 1.  N u m b er of mi n ut es of ex ercis e p er w e e k:  
2 2.  N u m b er of st e ps p er d ay:  
•  
W h at t y p e of ex ercis e is p erf or m e d ?  
2 3.  Pr e vi o us att e m pts f or w ei g ht l oss:  
2 4.  Pr e vi o us att e m pts wit h di et:  
•  
H o w m uc h w ei g ht w as l ost ?  
•  
H o w m uc h w as r e g ai n e d aft er t h e di et ?  
•  
N a m e of t h e di et:  
2 5.  A n y hist or y of us e of pr e vi o us c o m m erci al pr o gr a ms ? ( W ei g ht w atc h ers)  
•  
W ei g ht l oss:  
•  
W ei g ht r e g ai n:  
•  
Y e ar:  
2 6.  H a v e y o u b e e n o n a ny m e dic ati o ns f or w ei g ht l oss ?  
a.  W ei g ht l oss:  
b.  W ei g ht r e g ai n:  
c. Y e ar:  

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2 7.   H a v e y o u h a d a n y s ur g eri es f or w ei g ht l oss ?  
a.  W ei g ht l oss:  
b.  W ei g ht r e g ai n:  
c. Y e ar:  
2 8.  H a v e y o u h a d a n y d e vic es f or w ei g ht l oss ?  
a.  W ei g ht l oss:  
b.  W ei g ht r e g ai n:  
c. Y e ar:  
2 9.  A n y pr e vi o us hist or y of a b d o mi n al s ur g eri es ?  
3 0.   D o y o u h av e a ny of t h e f oll o wi n g ?  
•  
T y p e 2 di a b et es or pr e di a b et es  
•  
H y p ert e nsi o n  
•  
O bstr ucti v e sl e e p a p n e a or s n ori n g  
•  
W ei g ht b e ari n g j oi nt dis e as e or art hritis  
•  
B ac k p ai n  
•  
F atty li v er dis e as e or N A S H  
•  
D e pr essi o n or a nxi et y  
•  
E m oti o n al e ati n g or f o o d cr avi n gs  
•  
Bi n g e e ati n g at ni g ht  
•  
Hi g h el ev at e d c h ol est er ol  
•  
Hist ory of c or o n ar y dis e as e  
•  
Hist ory of c a nc er  
3 1.  D o y o u h a v e a ny h e art pr o bl e ms ?  
3 2.  D o y o u h a v e a ny l u n g pr o bl e ms or br e at hi n g iss u es?  
3 3.  D o y o u h a v e a ny p ets ?  
3 4.  W h e n y o u w a k e u p i n t h e m or ni n g, d o y o u f e el h u n gr y ?  
3 5.  W h at ti m e is y o ur first m e al of t h e d ay ?  
3 6.  H o w m a ny m e als d o y o u h av e i n a d ay ?  
3 7.  D o y o u s n ac k i n b et w e e n m e als ?  
3 8.  W h e n y o u st art e ati n g y o ur m e als, d o y o u f e el f ull ?  
3 9.  W h e n y o u st art e ati n g y o ur m e als, d o y o u st o p w h e n y o u f e el f ull ?  
4 0.  O nc e y o u h av e f elt f ull, f or h o w l o n g d o y o u r e m ai n f ull ? Pl e as e a ns w er i n mi n ut es or h o urs.  
4 1.  D o y o u h a v e a ny p artic ul ar f o o d cr a vi n gs t hr o u g h o ut t h e d a y ?  
4 2.  D o y o u h a v e a ny s n ac ks aft er y o ur l ast m e al of t h e d ay ?  
4 3.  D o y o u c o ns u m e a ny ot h er b e v er a g es t h at h av e c al ori es or artifici al s w e et e n ers?  
4 4.  D o y o u c o ns u m e c off e e ?  
•  
If y es, h o w m a ny c u ps a d ay ?  
4 5.  W h at w o ul d b e y o ur w ei g ht l oss g o al ?  
4 6.  W h e n y o u g o i nt o a di et, w hic h of t h e f oll o wi n g d o y o u ex p eri e nc e ?  
•  
I ncr e as e d a p p etit e (I’ m st ar vi n g t hr o u g h o ut t h e d ay)  
•  
Diffic ulty f e eli n g f ull  
•  
Si g nific a nt cr avi n gs  
•  
F e eli n g v er y m o o d y  

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•  
F e eli n g l ac k of e n er gy  
•  
F e eli n g v er y f ati g u e  
•  
Diffic ulty sl e e pi n g  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4 8  
 
A cti vit y Di ar y  & F o o d di ar y S u m m ar y  
 
 
 
 
 
 
 
 
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
D at e _ _ _ _ _ _ _  
D o s e 
1:  
_ _ _ _: _ _ _ _ A M  St e p s:  _ _ _ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
( s oli d): 
_ _ _ _ _ _ _  
C o n s u m e d 
C al ori e s 
(li q ui d): 
_ _ _ _ _ _ _  E x er ci s e:  
_ _ _ _ _ _ 
mi n  
D o s e 
2:  
_ _ _ _: _ _ _ _ P M  
 

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V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
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P h ysic al e x a m a n d Me dic al hist or y  
 
 
 
I R B #:  
2 1 -0 0 8 3 1 0   
 
 
 
 
M C #:   
 
 
 
 
F M H:  
 
 
N a me:   
 
 
 
 
S oci al:  
D O B : 
 
 
 
 
H PI:   
 
 
 
 
P E:  
R ace :  
 
 
 
 
Ht:  
 
Wt.  
 
B MI:  
 
 
 
 
 
 
 
 
 
 
 
 
 
B P:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
P:  
 
R:  
 
T:  
 
 
Me ds:  
( _ _see attac he d) 
 
 
 
 
 
 
 
 
 
 
 
 
P E: S yste m re vie w:  
 
 
 
 
 
 
Ge ner al : Well a p peari n g a n d i n n o ac ute distress 
 
 
 
 
 
 
S ki n : N o ras hes or ble mis hes 
Aller gies:  
 
 
 
 
He a d : N or m oce p halic 
 
 
 
 
 
 
E yes : P u pils e q ual, r o u n d a n d reacti ve t o li g ht 
 
 
 
 
 
 
E N T:  N or mal or o p har y n x a n d e xter nal n ose a n d ears  
 
 
 
 
 
n or mal   
 
 
 
  
 
 
 
 
 
 
Nec k : N o t h yr oi d masses or t h yr o me gal y 
Me nstr u al H x:  
 
 
 
L y m p h:  N o cer vical, i n g ui nal, a xillar y  
 
 
 
 
 
 
 
l y m p ha de n o pat h y 
C hil d be ari n g ?  Y or  N   
 
 
He art:  N or mal S 1, S 2 wit h o ut m ur m ur, r u b or gall o p  
 
 
 
 
 
 
L u n gs:  
If n o: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
A b d o m e n/ GI : N o nte n der, s oft, b o wel s o u n ds  
 
 
 
 
 
 
prese nt.  N o he pat os ple n o me gal y.  
P M H/ P S H : 
 
 
 
 
M usc ul os k elet al:  N o j oi nt eff usi o n, e de ma or  
 
 
 
 
 
 
er yt he ma 
 
 
 
 
 
 
E xtre mities:  N o e de ma  
 
 
 
 
 
 
Rect al:  
 
 
 
 
 
 
Ne ur ol o gic al : 
 
 
 
 
 
 
Ps yc h ol o gic al:  
 
 
 
 
 
 
Ot her:  
 
 

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Acti vit y Tr ac k er I nstr ucti o ns  
H O W D O I C R E A T E A FI T BI T A C C O U N T A N D C O N N E C T M Y D E VI C E ?  
T h e Fit bit a p p is c o m p ati bl e wit h m ost p o p ul ar p h o n es a n d t a bl ets, as w ell as Wi n d o ws 1 0 c o m p ut ers. T o 
v erif y t h at y o ur p h o n e or t a bl et is c o m p ati bl e wit h t h e Fit bit a p p, g o t o
 
If y o ur p h o n e or t a bl et is n’t c o m p ati bl e, a n d y o u d o n’t h a v e a Wi n d o ws 1 0 c o m p ut er, y o u c a n s et u p s o m e 
Fit bit d e vic es o n a M ac or Wi n d o ws 8. 1 c o m p ut er wit h a pr o gr a m c all e d Fit bit C o n n ect.  
C h o os e a li nk b el o w d e p e n di n g o n w h et h er y o u pr ef er t o s et u p y o ur d evic e wit h t h e Fit bit a p p or wit h Fit bit 
C o n n ect.  
•  
 
 
 
FI T BI T A P P  
N ot e: If y o u’r e s etti n g u p Fit bit C h ar g e 4 or Fit bit V ers a 2 wit h a n A n dr oi d p h o n e, a n otific ati o n a p p e ars o n 
y o ur p h o n e t o b e gi n t h e s et u p pr oc ess. T a p t h e n otific ati o n a n d f oll o w t h e o n -scr e e n i nstr ucti o ns t o s et u p 
y o ur d evic e. If y o u d o n’t h av e t h e Fit bit a p p, t h e n otific ati o n t a k es y o u t o t h e G o o gl e Pl ay St or e t o d o w nl o a d 
t h e a p p. 
 
T o s et u p y o ur Fit bit d e vic e wit h t h e Fit bit a p p:  
1.  D o w nl o a d a n d i nst all t h e Fit bit a p p fr o m o n e of t h e f oll o wi n g l oc ati o ns:  
•  
A p pl e d evic es —
 
•  
A n dr oi d d evic es —
  
•  
Wi n d o ws 1 0 d evic es ( p h o n es, t a bl ets, a n d c o m p ut ers) —
 
N ot e t h at y o u n e e d a n acc o u nt wit h t h e st or e b ef or e y o u c a n d o w nl o a d a p ps.  
2.  O p e n t h e Fit bit a p p a n d t a p  J oi n Fit bit. 
•  
T h e e m ail a d dr ess f or y o ur acc o u nt is: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
•  
T h e P ass w or d f or y o ur acc o u nt is:  _ _ _ _ _
_ _ _ _ _ - pl e as e us e t his p ass w or d, 
a n d b e u p p er/l o w er c as e s e nsiti v e.  
•  
Pl e as e D O N O T c h a n g e eit h er of t h es e f or t h e d ur ati o n of t h e st u dy.  
3.  F oll o w t h e o n -scr e e n i nstr ucti o ns t o cr e at e a Fit bit acc o u nt a n d c o n n ect (" p air") y o ur Fit bit d e vic e t o 
y o ur p h o n e or t a bl et.  P airi n g m a k es s ur e y o ur Fit bit d e vic e a n d p h o n e or t a bl et c a n c o m m u nic at e 
wit h o n e a n ot h er (sy nc t h eir d at a).  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
5 1  
 
 
N ot e t h at t o cr e at e a Fit bit acc o u nt, y o u'r e pr o m pt e d t o e nt er y o ur birt h d at e, h ei g ht, w ei g ht, a n d s ex t o 
c alc ul at e y o ur stri d e l e n gt h a n d t o esti m at e dist a nc e, b as al m et a b olic r at e, a n d c al ori e b ur n. F or m or e 
i nf or m ati o n, s e e
 Aft er y o u s et u p y o ur acc o u nt, y o ur 
first n a m e, l ast i niti al, a n d pr ofil e pict ur e ar e visi bl e t o all ot h er Fit bit us ers. Y o u h av e t h e o pti o n t o s h ar e 
ot h er i nf or m ati o n, b ut m ost of t h e i nf or m ati o n y o u pr ovi d e t o cr e at e a n acc o u nt is pri v at e b y d ef a ult. 
FI T BI T D E VI C E C O N N E C T  
If y o u d o n’t h av e a c o m p ati bl e p h o n e or t a bl et, y o u c a n s et u p a n d sy nc m ost Fit bit d e vic es o n y o ur c o m p ut er 
wit h Fit bit C o n n ect. Fit bit C o n n ect is a fr e e s oft w ar e a p plic ati o n t h at l ets y o ur Fit bit d e vic e sy nc its d at a wit h 
y o ur fit bit.c o m d as h b o ar d. T o l e ar n m or e a b o ut t h e fit bit.c o m d as h b o ar d, s e e  
 
 
If y o ur c o m p ut er is n’t Bl u et o ot h-e n a bl e d, y o u m ust us e a wir el ess sy nc d o n gl e t o s et u p a n d sy nc y o ur Fit bit 
d e vic e. M ost Fit bit d e vic es d o n’t c o m e wit h a d o n gl e, b ut y o u c a n b uy o n e fr o m t h e Fit bit  St or e. W e 
r ec o m m e n d usi n g t h e Fit bit a p p if y o u c a n. 
T o i nst all Fit bit C o n n ect a n d s et u p y o ur d e vic e:  
1.  If y o ur c o m p ut er is n’t Bl u et o ot h-e n a bl e d, i ns ert a wir el ess sy nc d o n gl e i nt o a U S B p ort o n y o ur 
c o m p ut er. 
2.  G o t o  
 
3.  Scr oll d o w n a n d clic k t h e pi nk  D o w nl o a d  b utt o n.  
4.  Aft er t h e d o w nl o a d c o m pl et es, d o u bl e -click t h e d o w nl o a d e d fil e t o st art i nst all ati o n. 
5.  Aft er i nst alli n g, w h e n pr o m pt e d, c h o os e  S et u p a N e w Fit bit D e vic e .  
6.  F oll o w t h e o n -scr e e n i nstr ucti o ns t o cr e at e a Fit bit acc o u nt a n d c o n n ect y o ur d e vic e.   
N ot e t h at t h e p ers o n al i nf or m ati o n y o u pr ovi d e d uri n g s et u p is us e d t o c alc ul at e y o ur b as al m et a b olic r at e 
( B M R), w hic h h el ps d et er mi n e y o ur esti m at e d c al ori e ex p e n dit ur e a n d y o ur b o d y m ass i n d ex ( B MI). F or m or e 
i nf or m ati o n, s e e 
 T his i nf or m ati o n is priv at e u nl ess 
y o u c h a n g e y o ur pri v acy s etti n gs a n d o pt t o s h ar e it wit h y o ur Fit bit fri e n ds.  
If y o u h av e tr o u bl e, s e e
 
 
Y o ur d evic e s h o ul d c o m e i n t h e m ail. O p e n t h e b ox, t a k e o ut t h e tr ac ki n g d evic e, p o w er it u p a n d li n k it t o 
y o ur m o bil e d e vic e.  
- 
Y o u will b e s e nt w e e kly di ari es t o fill i n d at a c oll ect e d t hr o u g h t h e fit bit a p p. If y o u h a v e a ny 
tr o u bl es n a vi g ati n g t h e a p p y o u c a n c o nt act t h e cli nic al r es e arc h c o or di n at or wit h w h o m y o u 
h av e b e e n i n c o nt act.  

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
5 2  
 
 
Dir ecti o ns:  
W e ar y o ur d e vic e all d ay a n d ni g ht, r e g ar dl ess of h o w acti v e or i n acti v e y o u ar e. All  t h e i nf or m ati o n it is 
c oll ecti n g t hr o u g h o ut t h e d ay is i m p ort a nt t o us! R e m ov e t h e d e vic e t o c h ar g e it, tr y t o d o t his d uri n g p eri o ds 
of i n acti vit y or ov er ni g ht.  
Sy nc y o ur d e vic e t o y o ur acc o u nt at l e ast ev er y 2 -3 d ays. Y o u c a n d o t his b y usi n g t h e a p p o n y o ur p h o n e, or 
b y c o n n ecti n g t h e d e vic e t o y o ur c o m p ut er a n d l o g gi n g i n t o y o ur acc o u nt.  
Pl e as e us e a ny a n d all  of t h e f e at ur es o n t h e d e vic e h o w e v er y o u w o ul d li k e. T his i ncl u d es t h e f o o d i nt a k e 
di ari es, acti vit y tr acki n g a n d sl e e p tr acki n g.  
If y o u h av e a ny q u esti o ns r e g ar di n g y o ur Fit bit or t h e acc o u nt pl e as e e m ail 
 
  
 
 
 
 
 

I R B # 2 1-0 0 8 3 1 0  
V ersi o n 3. 0  
6 -1 4 -2 0 2 3  
5 3  
 
R E F E R E N C ES:  
  
 
1.  
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2.  
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3.  
H al es, C. M., et al., Pr ev al e nc e of O b esity a n d S ev er e O b esity A m o n g A d ults: U nit e d St at es, 2 0 1 7 -2 0 1 8.  N C H S 
D at a Bri ef, 2 0 2 0( 3 6 0): p. 1 -8.  
4.  
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5.  
Ji a n g, J., et al., Ass oci ati o n of o b esity wit h c ar di ov asc ul ar dis e as e m ort ality i n t h e PL C O tri al.  Pr e v e nti v e 
M e dici n e, 2 0 1 3. 5 7 ( 1): p. 6 0-6 4.  
6.  
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A m o n g P ost m e n o p a us al W o m e n.  J A M A N et w or k O p e n, 2 0 1 9. 2 ( 7): p. e 1 9 7 3 3 7-e 1 9 7 3 3 7.  
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a n d O b esity — T h er a p e utic I m plic ati o ns.  N utri e nts, 2 0 2 1. 1 3 ( 4): p. 1 1 5 8. 
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1 1.  
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1 2.  
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1 3.  
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1 4.  
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