Clinical trial NCT05314374
Conditions: Obesity Healthy
Keywords: BMI of 30 or greater
Sponsor: Mayo Clinic
Start date: 2023-05-12; Completion date: 2024-11-13
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight.

Detailed description:

Arms: arm 1: Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements arm 2: Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Interventions: intervention 1: Ileocolonic-release conjugated bile acid intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. intervention 2: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
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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* 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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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)


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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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6 -1 4 -2 0 2 3  
3 4  
 
P a g e 1  


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3 7  
 
 


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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  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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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  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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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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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  
4 9  
 
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).  


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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.  


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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 
 
  
 
 
 
 
 


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R E F E R E N C ES:  
  
 
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