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Very
Low-Calorie
Diets
National
Task
Force
on
the
Prevention
and
Treatment
of
Obesity
Objective.\p=m-\To
provide
an
overview
of
the
published
scientific
information
on
the
safety
and
efficacy
of
very
low-calorie
diets
(VLCDs)
and
to
provide
rational
recom-
mendations
for
their
use.
Data
Sources
and
Extraction.\p=m-\Original
reports
obtained
through
a
MEDLINE
search
for
1966
through
1992
on
VLCDs
or
reducing
diets
plus
obesity,
supple-
mented
by
a
manual
search
of
bibliographies
and
the
opinions
of
experts
in
the
field
of
nutrition
and
weight
loss
therapy
for
obesity.
Only
studies
of
humans
were
cited.
Data
Synthesis.\p=m-\Current
VLCDs
are
usually
provided
in
the
context
of
comprehensive
treatment
programs,
during
which
usual
food
intake
is
completely
replaced
by
specific
foods
or
liquid
formulas
containing
3350
kJ/d
(800
kcal/d)
or
less.
Weight
loss
on
VLCDs
averages
1.5
to
2.5
kg/wk;
total
loss
after
12
to
16
weeks
averages
20
kg.
These
results
are
superior
to
standard
low-calorie
diets
of
5020
kJ/d
(1200
kcal/d),
which
lead
to
weight
losses
of
0.4
to
0.5
kg/wk
and
an
av-
erage
total
loss
of
only
6
to
8
kg.
There
is
little
evidence
that
intakes
of
less
than
3350
kJ/d
(800
kcal/d)
result
in
better
weight
losses
than
3350
kJ.
Intake
of
at
least
1
g/kg
of
ideal
body
weight
per
day
of
protein
of
high
biologic
value
appears
to
be
important
in
helping
to
preserve
lean
body
mass.
Serious
complications
of
modern
VLCDs
are
unusual,
cholelithiasis
being
most
common.
Conclusions.\p=m-\Current
VLCDs
are
generally
safe
when
used
under
proper
medical
supervision
in
moderately
and
severely
obese
patients
(body
mass
index
[weight
in
kilograms
divided
by
height
in
meters
squared]
>30)
and
are
usually
ef-
fective
in
promoting
significant
short-term
weight
loss,
with
concomitant
improve-
ment
in
obesity-related
conditions.
Long-term
maintenance
of
weight
lost
with
VLCDs
is
not
very
satisfactory
and
is
no
better
than
with
other
forms
of
obesity
treatment.
Incorporation
of
behavioral
therapy
and
physical
activity
in
VLCD
treat-
ment
programs
seems
to
improve
maintenance.
(JAMA.
1993;270:967-974)
OBESITY
is
one
of
the
most
common
and
important
medical
conditions
affect¬
ing
Americans.
At
least
26%
of
adult
Americans
are
significantly
over¬
weight,1·2
and
the
prevalence
of
obesity
reaches
50%
in
some
minority
popula¬
tions,
particularly
American
Indian,
black,
and
Hispanic
women.3,4
The
im¬
portance
of
obesity
is
emphasized
by
epidemiologie
studies,
which
show
a
clear
excess
mortality
associated
with
obesi¬
ty,
as
well
as
an
increased
risk
for
dia¬
betes,
heart
disease,
stroke,
hyperten¬
sion,
gallstones,
and
certain
types
of
can¬
cer.5
The
prevention
and
treatment
of
obesity
are
health
priorities
that
cannot
be
ignored.6
From
the
National
Task
Force
on
the
Prevention
and
Treatment
of
Obesity,
National
Institutes
of
Health,
Bethesda,
Md.
Reprint
requests
to
Division
of
Digestive
Diseases
and
Nutrition,
National
Institute
of
Diabetes
and
Diges-
tive
and
Kidney
Disease,
National
Institutes
of
Health,
Bldg
31,
Room
9A23,
Bethesda,
MD
20892
(Jay
H.
Hoofnagle,
MD).
Despite
its
importance,
the
preven¬
tion
of
obesity
remains
an
elusive
goal.
The
major
reasons
for
this
are
that
obe¬
sity
is
a
heterogeneous
disorder
and
its
causes
are
incompletely
understood.
Obe¬
sity
has
a
strong
genetic
component,710
but
environmental
influences
obviously
play
an
important
role
in
its
develop¬
ment
and
maintenance.1113
Until
the
spe¬
cific
genetic
and
environmental
factors
that
modulate
food
intake,
energy
ex¬
penditure,
and
fat
distribution
are
un¬
derstood,
rational
means
of
preventing
obesity
will
be
difficult
to
devise.
Treatment
of
obesity
is
also
problem¬
atic.
In
theory,
control
of
obesity
should
be
quite
simple.
But
for
most
obese
pa¬
tients,
weight
loss
is
extremely
difficult,
and
maintenance
ofthat
weight
loss
even
more
so.14
The
frequency
with
which
attempts
to
treat
obesity
have
met
with
failure
has
led
to
a
multitude
of
dietary,
behavioral,
pharmacologie,
mechanical,
and
even
surgical
approaches
to
control
weight.
The
forms
of
these
diets
vary
enormously
in
degree
of
caloric
restric-
tion,
relative
amounts
of
macronutrients
(protein,
carbohydrate,
fat),
medical
su¬
pervision,
scientific
basis,
and
cost.
Sur¬
veys
indicate
that
during
any
1
year,
up
to
25%
of
men
and
50%
of
women
diet
to
lose
weight.1511'
In
1989,
Americans
spent
over
$30
billion
trying
to
lose
weight.17
Among
the
various
forms
of
dietary
weight
loss
methods,
perhaps
the
most
controversial
are
the
very
low-calorie
diets
(VLCDs).
Very
low-calorie
diets
were
devised
to
provide
larger
and
more
rapid
short-term
weight
loss
than
stan¬
dard
low-calorie
diets
(LCDs),
while
avoiding
the
dangers
and
adverse
ef¬
fects
of
total
fasting.
The
controversy
over
VLCDs
relates
to
their
safety
and
their
long-term
efficacy.
What
are
the
relative
advantages
of
VLCDs
over
con¬
ventional
LCDs?
What
are
their
limi¬
tations
and
complications?
This
position
paper
has
been
prepared
by
the
Nation¬
al
Task
Force
on
the
Prevention
and
Treatment
of
Obesity
to
provide
a
bal¬
anced
overview
of
the
scientific,
pub¬
lished
information
on
the
safety
and
ef¬
ficacy
of
VLCDs
and
to
provide
rational
recommendations
for
their
use.
THE
NATIONAL
TASK
FORCE
ON
THE
PREVENTION
AND
TREATMENT
OF
OBESITY
Scientific
Members.\p=m-\Richard
L.
Atkinson,
MD
(Department
of
Veterans
Affairs,
Hamp-
ton,
Va),
William
H.
Dietz,
MD
(New
England
Medical
Center,
Boston,
Mass),
John
P.
Fo-
reyt,
PhD
(Baylor
College
of
Medicine,
Hous-
ton,
Tex),
Norma
J.
Goodwin,
MD,
(HEALTH
WATCH
Information
and
Promotion
Service,
New
York,
NY),
James
O.
Hill,
PhD
(Vander-
bilt
University,
Nashville,
Tenn),
Jules
Hirsch,
MD
(Rockefeller
University,
New
York,
NY),
F.
Xavier
Pi-Sunyer,
MD
(St
Luke's-Roosevelt
Hospital
Center,
Columbia
University,
New
York,
NY),
Roland
L.
Weinsier,
MD,
DrPH
(University
of
Alabama,
Birmingham),
Rena
Wing,
PhD
(University
of
Pittsburgh
[Pa]
School
of
Medicine).
National
Institutes
of
Health,
Staff
Mem-
bers.\p=m-\Susan
Zelitch
Yanovski,
MD,
Van
S.
Hubbard,
MD,
PhD,
and
Jay
H.
Hoofnagle,
MD
(Division
of
Digestive
Diseases
and
Nu-
trition,
National
Institute
of
Diabetes
and
Di-
gestive
and
Kidney
Disease,
National
Insti-
tutes
of
Health,
Bethesda,
Md).
by guest on July 17, 2009 www.jama.comDownloaded from
DEFINITION
A
VLCD
can
be
defined
as
a
hypo-
caloric
diet
containing
3350
kj
(800
kcal)
or
less
per
day,
or
less
than
50
kJ
(<12
kcal/kg
of
ideal
body
weight
[IBW]
per
day).
In
contrast,
a
LCD
provides
3350
to
6280
kJ
(800
to
1500
kcal)
or
50
to
80
kJ
(12
to
20
kcal/kg
of
IBW
per
day).18
However,
VLCDs
should
not
be
defined
solely
on
the
basis
of
caloric
content.
The
following
four
features
are
charac¬
teristic
of
most
VLCDs:
1.
Very
low-calorie
diets
are
hypoca-
loric,
but
are
relatively
enriched
in
protein
(0.8
to
1.5
gm/kg
of
IBW
per
day).
Very
low-calorie
diets
are
more
than
simple
low-fat,
low-carbohydrate,
high-protein
diets;
they
are
more
accurately
described
as
modified
fasts
and
are
accompanied
by
appropriate
metabolic
adaptation.19
2.
Very
low-calorie
diets
are
designed
to
include
the
full
complement
of
the
rec¬
ommended
daily
allowance
(RDA)
for
vi¬
tamins,
minerals,
electrolytes,
and
fatty
acids,20
but
not,
of
course,
for
calories.
It
is
important
to
stress,
however,
that
the
RD
As
were
developed
for
normal-weight,
healthy
individuals
and
do
not
necessar¬
ily
satisfy
the
metabolic
needs
for
indi¬
viduals
who
are
obese,
are
rapidly
losing
weight,
or
are
under
physiologic
stress.
3.
Very
low-calorie
diets
are
given
in
a
form
that
completely
replaces
usual
food
intake.
The
most
commonly
used
VLCDs
have
been
liquid
formulations,
often
provided
as
a
powder
to
be
mixed
with
water.
Food-based,
protein-sparing
modified
fasts
(lean
meat,
fish,
and
fowl)
have
several
potential
advantages
over
formula
VLCDs,
including
lower
cost
and
the
provision
of
micronutrients
and
oth¬
er
food
substances
contained
in
natural
food
sources.21·22
However,
separate
vi¬
tamin
and
mineral
supplements
must
be
consumed
with
food-based
VLCDs,
while
these
are
included
in
formula
diets.
4.
Very
low-calorie
diets
are
usually
given
for
a
prolonged
period,
typically
12
to
16
weeks.23,24
While
preparations
that
appear
similar
to
VLCDs
are
avail¬
able
over-the-counter,
these
are
meant
to
be
used
as
replacements
for
one
or
two
meals
a
day,
and
not
as
a
sole
source
of
nutrition;
their
use
as
total
meal
re¬
placement
is
potentially
dangerous
and
should
be
strongly
discouraged.23
For
the
purposes
of
this
article,
VLCDs
are
defined
as
formula
diets
containing
3350
kJ
(800
kcal/d)
or
less,
which
completely
replace
usual
food
intake
and
are
taken
for
at
least
4
weeks.
BACKGROUND
The
development
of
VLCDs
in
the
1920s2S~28
arose
out
of
a
need
to
attain
larger
and
more
rapid
weight
loss
than
was
possible
with
conventional
diets,
but
to
avoid
the
dangers
of
total
starvation.
The
caloric
levels
of
VLCDs
allowed
for
the
ingestion
of
essential
macronutrients,
vitamins,
and
minerals
and
avoidance
of
the
losses
of
lean
body
mass
and
severe
side
effects
associated
with
fasting.29·30
Widespread
interest
in
VLCDs
began
in
the
1970s
with
the
introduction
of
the
"protein-sparing
modified
fast."21·22
This
diet
consisted
of
2720
to
3350
kJ
(650
to
800
kcal)
daily
provided
by high-protein
foods
(lean
red
meat,
chicken,
fish)
given
at
a
level
of
1.5
g
of
protein
per
kilogram
of
IBW
per
day.
The
protein
was
of
high
biologic
value
(rich
in
essential
amino
ac¬
ids)
and
was
of
adequate
quantity
to
help
maintain
nitrogen
balance.
This
approach
to
weight
loss
was
reportedly
successful
in
a
large
number
of
patients.
The
solid-
food-based,
protein-sparing
modified
fast
was
then
adapted
and
refined
in
the
late
1970s
as
liquid
formula
preparations.31"37
In
the
1970s,
some
commercial
prep¬
arations
were
made
largely
from
col¬
lagen
and,
thus,
contained
protein
of
low
biologic
value.
Reports
of
ventricular
dysrhythmias
and
sudden
death
during
liquid
protein
diets
led
to
a
formal
Pub¬
lic
Health
Service
investigation
of
their
use
and
complications.38
The
final
report
described
58
cases
of
sudden,
unexpect¬
ed
death
attributed
to
the
low
quantity
and
poor
quality
of
the
protein
in
the
liquid
preparations
and
to
their
use
for
extensive
periods
with
inadequate
med¬
ical
supervision.
The
reports
of
sudden
deaths
attrib¬
uted
to
liquid
protein
diets
led
to
a
more
conservative
use
and
to
attempts
to
im¬
prove
the
quality
and
balance
of
the
nu¬
trients.
Most
VLCDs
now
provide
45
to
100
g
of
protein
with
high
biologic
value
(from
dairy
or
egg
sources)
per
day.24
Carbohydrates
are
also
added
in
amounts
up
to
100
g/d.
Fats in
the
form
of
oils
containing
essential
fatty
acids,
have
also
been
increased
in
VLCDs,
as
have
vitamins
and
essential
minerals.
The
most
fundamental
change
in
VLCDs
in
recent
years
has
been
a
grad¬
ual
increase
in
the
number
of
calories
from
1500
to
2510
kJ
(360
to
600
kcal/d)
originally
to
1760
to
3350
kJ
(420
to
800
kcal/d)
in
current
products.24·39
The
amount
of
weight
lost
over
12
to
16
weeks
with
VLCDs
providing
3350
kJ
(800
kcal)
daily
is
little
different
from
that
on
diets
providing
1760
or
2510
kJ
(420
or
600
kcals)
daily,
probably
the
result
of
im¬
proved
compliance.4042
CLINICAL
STUDIES
OF
VLCDs
Patients
Treated
and
Weight
Loss
Programs
In
a
large
number
of
studies,
VLCDs
have
been
shown
to
be
effective
in
bring¬
ing
about
significant
weight
loss
in
obese
patients.18·4·3
Treatment
with
VLCDs
has
largely
been
limited
to
persons
who
have
failed
to
lose
weight
in
more
conven¬
tional
diet
programs
and
who
are
mod¬
erately
to
severely
obese,
which
is
usu¬
ally
defined
as
a
body
mass
index
(BMI)
higher
than
30
(calculated
by
dividing
the
weight
in
kilograms
by
the
height
in
meters
squared).44
Most
studies
of
VLCDs
have
used
them
as
part
of
a
more
general
weight
control
program
that
includes
exercise,
behavior
modification,
and
nutritional
education
to
help
promote
long-term
weight
control.
The
treatment
program
is
usually
conducted
by
a
multidisci-
plinary
team,
using
physicians,
behav¬
ior
therapists,
dietitians,
and
exercise
physiologists.
Patients
are
seen
in
groups,
which
meet
weekly.45
The
VLCD-based
weight
loss
pro¬
grams
usually
include
four
phases:
(1)
introduction,
during
which
patients
con¬
sume
a
balanced
LCD
of
5020
to
6280
kJ
(1200
to
1500
kcal)
daily
for
1
to
4
weeks;
(2)
modified
fast
phase,
during
which
they
consume
the
VLCD
only;
(3)
re-
feeding
phase,
during
which
solid
foods
are
reintroduced;
and
(4)
stabilization/
maintenance
phase,
during
which
a
ma¬
jor
focus
is
placed
on
nutritional
educa¬
tion
and
behavior
modification
to
help
sustain
the
weight
loss.
A
disadvantage
of
VLCD
programs,
as
currently
conducted,
is
their
high
cost,
estimated
at
approximately
$3000
for
a
26-week
program.
However,
the
cost
per
kilogram
for
weight
lost
on
a
VLCD
program
is
estimated
to
be
similar
to
that
incurred
in
a
26-week
behavioral
program,
when
allowances
are
made
for
costs
of
food
and
the
medical
evalua¬
tions.46
The
costs,
however,
are
still
sub¬
stantially
more
than
for
self-help
or
work-site
programs.
Additionally,
by
1
year,
the
cost
per
kilogram
of
weight
lost
is
significantly
higher
with
VLCDs
than
with
LCDs,
given
the
larger
re¬
gain
in
VLCDs.
Short-term
Weight
Loss
The
primary
benefit
of
VLCDs
is
that
they
can
produce
large
weight
losses
within
a
12-week
to
24-week
period
in
a
significant
proportion
of
patients.
In
con¬
trolled
clinical
trials,
90%
of
patients
treated
with
VLCDs
lost
10
kg
or
more.45·47
This
outcome
surpassed
the
re¬
sults
of
studies
with
balanced
LCDs
where
only
60%
lose
10
kg
or
more
and
far
exceeds
results
with
LCDs
reported
in
the
1950s
where
only
25%
of
patients
lost
an
equivalent
amount.48
Very
low-
calorie
diets
resulted
in
an
average
loss
of
1.5
to
2.0
kg/wk
in
women
and
2.0
to
2.5
kg/wk
in
men,
with
average
total
losses
of
20
kg
over
12
weeks.
In
contrast,
LCDs
combined
with
behavioral
treatment
pro-
by guest on July 17, 2009 www.jama.comDownloaded from
-5
—
.g>-io-
3
15-
-20-
VLCD
Alone
LCD
+
BT
VLCD
+
BT
-0.5
2
3
Years
After
Treatment
Long-term
weight
change
of
subjects
treated
by
very
low-calorie
diet
(VLCD),
low-calorie
diet
(LCD)
and
behavior
therapy
(BT),
and
VLCD
plus
BT
(combined
treatment).
Subjects
in
the
VLCD
condition
received
a
5020-kJ/d
(1200
kcal/d)
diet
the
first
month,
a
VLCD
(providing
1670-2090
kJ/d
[400
to
500
kcal/d])
the
second
and
third
months,
and
a
refeeding
diet
the
fourth
month
(at
which
time
treatment
ended).
They
re¬
ceived
no
training
in
behavioral
methods
of
weight
control.
Subjects
in
the
BT
condition
received
a
5020-
kj/d
(1200
kcal/d)
diet
during
6
months
of
treatment
and
extensive
instruction
in
modifying
eating
and
ex¬
ercise
habits.
Subjects
in
the
combined
treatment
condition
received
the
same
diet
as
those
in
the
VLCD
condition
plus
a
5020-kJ/d
(1200
kcal/d)
diet
for
months
5
and
6.
They
also
received
the
behavioral
training
provided
subjects
in
the
BT
condition
(adapted
from
Wadden
et
al4554;
figure
modified
from
a
figure
to
be
published
in
an
article
to
appear
in
the
Annals
of
Internal
Medicine,
which
is
publishing
the
proceedings
of
the
National
Intitutes
of
Health
Technology
Assessment
Conference
on
Weight
Loss
and
Control).
duced
losses
of
only
0.4
to
0.5
kg/wk,
with
average
losses
of
8.5
kg
in
20
to
24
weeks.45·49"51
In
controlled
studies,
the
at¬
trition
rates
with
VLCDs
vs
LCDs
have
been
comparable
(15%
to
20%).
Many
clinical
trials
of
VLCDs
have
been
reported
from
academic
centers
and
the
rates
of
response
were
probably
high¬
er
and
rates
of
attrition
lower
than
those
in
commercial
or
private
weight
loss
pro¬
grams.
A
recent
multicenter
evaluation
of
a
proprietary
weight
loss
program
that
included
12
weeks
of
a
VLCD
found
a
dropout
rate
of
45%.
The
average
weight
loss
among
those
who
completed
the
pro¬
gram
was
22
kg
in
women
and
32
kg
in
men
and
for
those
who
dropped
out
early
was
14
kg
in
women
and
20
kg
in
men.52
Most
reports
on
the
effectiveness
of
VLCDs
have
not
included
such
analyses
of
patients
who
failed
to
complete
the
diet
program,
which
would
introduce
a
bias
in
favor
of
larger
weight
losses.
Few
studies
have
analyzed
long-term
use
of
VLCDs.31
Continued
weight
loss
was
achieved
with
use
of
VLCDs
for
up
to
45
weeks
in
one
trial,
but
the
rate
of
weight
loss
decreased
after
12
weeks.32
Repeated
use
of
VLCDs
has
not
been
studied
systematically.
In
some
trials,
compliance,
and
subsequent
weight
loss,
have
been
reduced
during
repeated
courses
of
VLCDs.63
Long-term
Weight
Maintenance
While
VLCDs
have
been
superior
to
LCDs
in
achieving
short-term
weight
loss,
they
have
not
been
better
in
achiev¬
ing
long-term
maintenance
of
weight
loss.
Indeed,
weight
maintenance
has
been
the
most
difficult
element
in
all
approaches
to
the
therapy
of
obesity.14
Among
the
many
reports
on
successful
use
of
VLCDs,
few
have
provided
com¬
prehensive
information
on
weight
main¬
tenance,
such
as
the
number
of
subjects
entering
the
program,
attrition
rate,
fol¬
low-up
rate,
and
amount
of
weight
loss
at
the
end
of
therapy
as
well
as
1
to
5
years
later.45·49"51
Wadden
and
coworkers45
treated
89
overweight
women
for
16
weeks
with
either
a
VLCD
alone
(protein-sparing
modified
fast
for
8
weeks,
LCD
for
8
weeks),
behavioral
therapy
and
a
VLCD,
or
behavioral
therapy
with
a
LCD.
Weight
loss
was
similar
with
a
VLCD
alone
as
with
an
LCD
and
behavioral
therapy
(13.1-kg
loss
vs
13.0-kg
loss),
but
was
greatest
with
the
combination
of
VLCD
and
behavioral
therapy
(16.8
kg)
(Figure).
Weight
loss
maintenance
at
1
year
was
optimal
when
behavioral
therapy
was
used,
but
at
5
years
all
three
treatment
groups
had
largely
re¬
gained
the
lost
weight.
Wing
et
al51
studied
36
obese
subjects
undergoing
behavioral
therapy
while
on
either
a
VLCD
or
an
LCD.
Weight
loss
was
greatest
with
the
VLCD
(18.6
kg
vs
10.1
kg);
at
1
year
this
difference
was
less
but
still
present
(8.6
kg
vs
6.8
kg).
Sikand
et
al50
studied
30
obese
women
who
were
treated
with
VLCD
and
be¬
havioral
therapy
with
or
without
exer¬
cise.
The
addition
of
exercise
did
not
in¬
crease
the
amount
of
weight
loss
achieved
during
the
diet
period
significantly
(21.8
kg
vs
17.5
kg);
however,
weight
mainte¬
nance
at
1
year
and
2
years
was
better
in
the
exercise
group
(at
2
years,
9.1-kg
loss
vs
0.8-kg
loss).
Thus,
exercise
did
not
appear
to
improve
weight
losses
over
the
short
term,
but
did
to
help
in
main¬
tenance.
Likewise,
many
studies
have
shown
that
exercise
is
one
of
the
best
predictors
of
long-term
weight
mainte¬
nance
in
obese
individuals.55"57
Noteworthy
were
the
more
positive
results
in
the
study
of
Miura
et
al49
in
which
Japanese
patients
were
treated
with
VLCDs,
behavior
modification,
or
the
combination.
They
found
that
the
effects
of
VLCDs
alone
were
not
impressive,
but
the
combination
of
VLCDs
and
behavior
modification
was
associated
with
not
only
long-term
main¬
tenance
but
actual
further
weight
loss
during
a
2-year
follow-up
period.
Taken
together,
the
findings
from
these
four
studies
suggest
that
VLCDs
produce
larger
initial
weight
losses
than
LCDs,
especially
when
combined
with
behavioral
therapy.
However,
long-term
maintenance
of
weight
loss
with
both
forms
of
dietary
therapy
is
relatively
poor.
While
long-term
weight
loss
is
slightly
improved
with
behavioral
ther¬
apy
and
exercise,
it
is
not
clear
whether
VLCDs
per
se
provide
a
better
long-
term
response
than
LCDs
with
the
same
behavioral
and
exercise
training.
It
should
be
stressed
that
the
long-
term
results
of
trials
of
VLCDs
were
not
completely
negative;
some
patients
maintained
significant
weight
losses.
In
the
study
of
Wadden
et
al,45
27%
of
pa¬
tients
treated
with
VLCDs
and
behav¬
ioral
therapy
were
5
kg
or
more
below
baseline
5
years
after
treatment
com¬
pared
with
11%
of
patients
treated
with
VLCDs
alone
and
13%
of
patients
treat¬
ed
with
LCDs
and
behavioral
therapy.
Because
the
natural
history
of
obesity
is
that
patients
continue
to
gain
weight
over
time,4,58
these
results
suggest
that
modest
long-term
weight
loss
is
possi¬
ble
for
some
obese
individuals
who
com¬
plete
programs
containing
all
suggested
elements.
by guest on July 17, 2009 www.jama.comDownloaded from
Effects
on
Body
Composition
The
weight
loss
on
VLCDs
has
been
shown
to
represent
both
fat
and
lean
body
mass
(ie,
muscle,
bone,
internal
or¬
gans),
the
usual
ratio
being
about
75%
fat
to
25%
lean
mass.59-61
These
ratios
are
similar
to
those
obtained
with
weight
loss
obtained
with
LCDs.46,62
Some
loss
of
body
protein
is
probably
inevitable
with
weight
loss,
but
the
amount
of
loss
may
be
altered
by
protein
intake.
Pro¬
tein
intakes
of
at
least
1
g/kg
of
IBW
per
day
have
been
shown
to
help
preserve
lean
tissue
cell
mass,41
although
higher
amounts
(1.2
to
1.4
g/kg
of
IBW
per
day)
may
be
necessary
to
maximize
this
pres¬
ervation.63
The
percentage
of
weight
loss
composed
of
lean
mass
is
generally
high¬
er
if
the
initial
body
weight
is
lower.64·65
Thus,
use
of
VLCDs
in
patients
with
less¬
er
degrees
of
obesity
may
be
associated
with
proportionately
higher
loss
of
lean
mass.
For
these
reasons,
VLCDs
should
be
used
only
in
persons
with
moderate
to
severe
degrees
of
obesity
(BMI,
>30),
unless
the
individual
has
a
condition
for
which
rapid
weight
loss
is
necessary.18·23
Energy
Expenditure
Individuals
on
both
LCDs
and
VLCDs
show
a
decrease
in
energy
ex¬
penditure,
primarily
through
a
lowering
of
the
resting
metabolic
rate
(RMR).66
Reduced
RMR
may
be
an
adaptive
mech¬
anism
to
protect
the
organism
during
starvation,
but
as
such
it
also
slows
the
rate
of
weight
loss
during
dieting.
Acute¬
ly,
RMR
falls
to
a
greater
degree
with
VLCDs
than
with
LCDs,67
but
most
stud¬
ies,68"70
although
not
all,71·72
have
found
that
RMR
after
refeeding
and
weight
maintenance
is
normal
when
adjusted
for
losses
in
fat-free
mass.
On
balance,
the
adaptive
response
to
caloric
restriction
among
obese
individuals
appears
to
less¬
en
following
refeeding,
with
normaliza¬
tion
for
their
new
weight,
and
there
is
no
evidence
that
VLCDs
slow
this
adaption
relative
to
LCDs.70
Improvement
in
Medical
Conditions
Responsive
to
Weight
Loss
The
use
of
a
VLCD
regimen
and
the
ensuing
weight
loss,
even
if
modest,
can
be
beneficial
for
a
number
of
comorbid
conditions
such
as
diabetes
mellitus,
hy¬
pertension,
and
hyperlipidemia.73
Typi¬
cally,
a
diabetic
patient's
glycémie
con¬
trol
improves
within
1
week
of
starting
a
VLDC,74™
and
usually
requires
adjust¬
ment
of
hypoglycémie
medications.
Blood
pressure
also
improves,
but
at
a
slower
rate.
During
typical
VLCDs,
blood
pres¬
sure
in
hypertensive
patients
will
de¬
crease
by
8%
to
13%.18·19·77·78
The
total
serum
cholesterol
level
usually
de¬
creases
by
5%
to
25%
over
the
first
4
to
6
weeks
of
VLCDs
as
does
low-density
lipoprotein
cholesterol.76·79·80
Some
stud¬
ies
have
shown
decreases
in
high-density
lipoprotein
cholesterol
over
the
short-
term,81
while
others
have
found
longer-
term
increases.73
Triglycéride
levels
de¬
crease
by
15%
to
50%
during
VLCDs
in
patients
with
hypertriglyceridemia.73·82
Other
severe
complications
of
obesity
can
be
improved
by
VLCDs,
including
sleep
apnea
and
right-sided
cardiac
fail¬
ure.83
A
VLCD
may
be
useful
in
the
obese
patient
who
needs
to
undergo
surgery,
but
whose
weight
and
associated
condi¬
tions
make
for
a
poor
operative
risk.84
Such
patients
typically
undergo
VLCD
followed
by
refeeding
before
their
surgery.
How¬
ever,
no
trials
have
compared
the
relative
merits
of
weight
loss
on
VLCDs
vs
LCDs
on
surgical
outcome
or
complications.
In
general,
improvements
in
medical
conditions
can
be
expected
to
be
sustained
only
to
the
extent
that
weight
loss
is
main¬
tained.
A
possible
exception
is
in
glycémie
control
in
type
II
diabetics.
Wing
et
al51
found
that
1
year
after
diabetic
women
underwent
8
weeks
of
a
VLCD,
fasting
blood
glucose
and
hemoglobin
AiC
levels
were
significantly
improved
compared
with
women
who
underwent
8
weeks
of
a
balanced
LCD,
despite
the
fact
that
both
groups
regained
similar
amounts
of
weight.
The
authors
attributed
the
dif¬
ferential
improvement
to
enhanced
insu¬
lin
secretion,
possibly
due
to
ß-cell
resto¬
ration
during
the
VLCD
component.
Improvement
in
Mood
Three
controlled
studies8587have
com¬
pared
the
psychological
responses
in
pa¬
tients
treated
with
VLCDs
with
those
in
patients
treated
with
LCDs.
When
combined
with
behavioral
treatment,
both
VLCDs
and
LCDs
were
associated
with
similar
improvement
in
mood.
Pa¬
tients
treated
with
VLCDs
alone
expe¬
rienced
no
improvement
in
depressive
symptomatology,
indicating
that
behav¬
ioral
treatment
was
responsible
for
the
improved
mood.85
The
relative
effects
of
VLCDs
and
LCDs
on
hunger
perceptions
have
been
evaluated
in
several
controlled
studies
in
which
these
diets
were
combined
with
behavior
modification
therapy.86·88
De¬
spite
the
differences
in
calories
consumed
and
amount
of
weight
lost,
VLCDs
did
not
lead
to
more
hunger
than
LCDs
and
in
some
formulations
were
associated
with
less.88
ADVERSE
EFFECTS
OF
VLCDs
Minor
Short-term
Adverse
Reactions
The
majority
of
patients
using
VLCDs
for
4
to
16
weeks
report
some
adverse
side
effects,
but
these
are
gen¬
erally
minor
and
well
tolerated.18·78
Com-
mon
side
effects
include
fatigue
or
weak¬
ness,
dizziness,
constipation,
hair
loss,
dry
skin,
brittle
nails,
nausea,
diarrhea,
changes
in
menses,
edema,
and
cold
in¬
tolerance.24
These
complications
are
tran¬
sient
and
rarely
require
modification
of
diet.
Physical
performance
is
generally
unimpaired.89
Mood
and
affect
usually
im¬
prove
in
patients
participating
in
VLCD
programs
that
incorporates
behavioral
treatment,
but
a
few
patients
will
devel¬
op
depression,
anxiety,
or
irritability
dur¬
ing
weight
loss.90
There
is
no
evidence
that
diet-induced
depression
is
more
com¬
mon
with
VLCDs
than
with
LCDs.
Significant
Short-term
Adverse
Reactions
More
severe
or
significant
side
effects
of
VLCDs
are
gout,
gallstones,
and
car¬
diac
disturbances.
The
relationship
of
these
complications
to
VLCDs,
as
op¬
posed
to
LCDs
has
not
yet
been
deter¬
mined.
These
adverse
reactions
are
most
common
during
the
period
of
refeeding
when
the
patient
is
gradually
introduced
to
solid
foods.9193
Hyperuricemia
and
Gout.—Serum
levels
of
uric
acid
may
rise
during
VLCDs,
but
generally
stay
below
590
pmol/L
(10
mg/dL).
If
uric
acid
levels
go
higher
or
symptoms
occur,
liberaliza¬
tion
of
carbohydrate
intake
and/or
med¬
ication
may
be
required.
Patients
with
a
history
of
gout
will
occasionally
de¬
velop
an
acute
attack
during
VLCDs,
but
this
is
rare
in
previously
asymp¬
tomatic
patients.18·23,78·94
Gallstones.—Gallstones
are
more
common
in
obese
than
nonobese
per¬
sons,
especially
in
women.95
Obese
per¬
sons
have
increased
lithogenicity
of
bile96·97
and
have
poor
gallbladder
con¬
tractility
and
stasis,
even
without
diet¬
ing.98
Dieting
with
rapid
weight
loss
ap¬
pears
to
increase
the
risk
of
gallstone
disease
further,
as
shown
by
several
re¬
cent
studies
in
which
subjects
on
VLCDs
underwent
abdominal
ultrasono-
graphic
examinations
at
the
beginning
and end
of
therapy.99
In
the
largest
such
study,
11%
of
648
patients
on
VLCDs
for
16
weeks
developed
gallstones
de¬
tectable
on
an
ultrasonogram
and
23%
of
these
developed
symptoms.100
It
is
unclear
whether
gallstone
formation
was
related
directly
to
VLCDs
per
se
or
to
the
amount
of
weight
loss,
as
there
were
no
concurrently
followed
control
sub¬
jects
on
standard
LCDs.
The
risk
of
de¬
veloping
gallstones
correlated
with
the
amount
of
weight
loss
and
with
the
start¬
ing
weight.
Cardiac
Complications.—Cardiac
complications,
including
risk
of
sudden
death,
have
been
a
concern
since
fatal
dysrhythmias
were
documented
to
occur
during
VLCDs
in
the
1970s.23·38
The
by guest on July 17, 2009 www.jama.comDownloaded from
pathogenesis
of
these
dysrhythmias
was
never
proven,
although
both
myocardial
protein
depletion
and
electrolyte
abnormalities
were
implicated.91,92·101
Ex¬
tensive
evaluations
of
patients
on
VLCDs
containing
protein
of
high
bio¬
logic
value
with
appropriate
electrolyte
supplementation
for
16
weeks
or
less
have
not
found
an
increased
incidence
of
ven¬
tricular
dysrhythmias102103
or
prolonga¬
tion
of
the
QT
interval.104
Because
the
severely
obese
are
at
an
increased
risk
for
sudden
death,105
it
is
difficult
to
de¬
termine
when
a
death
is
attributable
to
a
VLCD
rather
than
the
underlying
obe¬
sity.
In
studies
involving
thousands
of
patients
consuming
VLCDs
with
protein
of
high
biologic
value,
the
mortality
was
as
low
or
lower
than
that
expected
in
similarly
obese
individuals
not
dieting.78
There
is
a
theoretical
increased
risk
of
adverse
cardiac
events
in
patients
with
lesser
degrees
of
obesity
(BMI
<30),
due
to
the
risk
of
excessive
protein
loss.64·65
GENERAL
RECOMMENDATIONS
Indications
Very
low-calorie
diets
may
be
indi¬
cated
in
well-motivated
individuals
who
are
moderately
to
severely
obese
(BMI
>30)
and
who
have
failed
at
more
con¬
servative
approaches
to
weight
loss.
In
particular,
individuals
with
medical
con¬
ditions
that
may
be
responsive
to
weight
loss,
such
as
sleep
apnea
or
non-insulin-
dependent
diabetes
mellitus,
may
be
ap¬
propriate
candidates.
Very
low-calorie
diets
may
occasionally
be
indicated
in
patients
with
a
BMI
of
27
to
30
who
have
medical
conditions
that
might
respond
to
rapid
weight
loss.
Children
and
Adolescents
In
children,
weight
loss
should
be
car¬
ried
out
under
the
supervision
of
a
phy¬
sician,
taking
into
account
the
child's
age,
height,
and
degree
of
overweight.
Ca¬
loric
intake
should
be
high
enough
to
support
normal
growth,106
and
protein
intakes
should
be
set
at
higher
levels
than
those
recommended
for
adults
on
VLCDs,
because
of
the
potential
for
com¬
plications
from
increased
nitrogen
losses
in
children.10710!)
Any
obesity
treatment
should
include
elements
of
behavioral
techniques
and
family
involvement.110
Re¬
strictive
diets,
such
as
VLCDs,
may
be
useful
in
the
management
of
some
se¬
verely
obese
children
and
adoles¬
cents,108·111
but
should
still
be
considered
experimental
and
carried
out
with
care¬
ful
and
experienced
medical
supervision.
Pregnancy
and
Lactation
Very
low-calorie
diets
are
contrain-
dicated
in
pregnant
women.
The
obese
pregnant
woman
should
aim
for
limited
weight
gain
rather
than
marked
weight
reduction.106
During
pregnancy,
marked
increases
in ketosis
occur
within
18
hours
of
fasting.112
In
women
with
diabetes
and
ketoacidosis,
maternal
ketosis
ap¬
pears
to
have
adverse
effects
on
the
fetus.113
Whether
the
mild
ketosis
of
semistarvation
has
effects
on
the
fetus
of
nondiabetic
women
is
not
known.
Nonetheless,
it
is
prudent
to
begin
ac¬
celerated
refeeding
should
a
woman
un¬
dergoing
a
VLCD
become
pregnant.
Very
low-calorie
diets
are
also
not
ap¬
propriate
for
lactating
women
as
they
have
increased
nutritional
requirements.
Older
Persons
Unfortunately,
little
information
ex¬
ists
regarding
the
safety
of
VLCDs
in
older
individuals.
Individuals
older
than
50
years
have
attrition
rates
and
weight
losses
equivalent
to
younger
individuals
during
VLCDs,
and
show
similar
ben¬
efits
in
reduction
of
blood
pressure
and
cholesterol
levels.114
Aged
persons
may
be
at
increased
risk
for
negative
nitro¬
gen
balance
with
weight
loss
because
of
an
already
normally
depleted
lean
body
mass10*'
and
because
of
lowered
immu¬
nologie
responses.115
In
addition,
adverse
reactions
to
VLCDs
might
be
less
well
tolerated
due
to
preexisting
medical
con¬
ditions
or
need
for
other
medications.
These
increased
risks
must
be
balanced
with
the
potential
benefit
of
weight
loss
in
older
persons.
Contraindications
and
Cautions
Contraindications
to
VLCDs
may
be
absolute
or
relative.
In
addition,
many
associated
medical
conditions
require
careful
monitoring.
Systemic
Infections
or
Diseases
Causing
Protein
Wasting.—Severe
acute
or
chronic
infections,
such
as
bac¬
terial
endocarditis,
osteomyelitis,
or
tu¬
berculosis,
are
associated
with
a
protein
catabolic
state,
which
could
be
wors¬
ened
by
VLCDs.
Patients
who
develop
such
conditions
while
on
VLCDs
should
have
their
diet
liberalized.
For
similar
reasons,
patients
with
protein-wasting
diseases,
such
as
Cushing
syndrome
or
active
malignancy,
should
not
undergo
VLCD,
and
these
diets
should
be
used
with
caution
on
patients
receiving
cor¬
ticosteroide.18·78
Cardiac
Disease.—Unstable
angina,
recent
(within
3
months)
myocardial
in¬
farction,
and
malignant
dysrhythmias
are
contraindications
to
VLCDs.
Pa¬
tients
with
known
prolonged
QT
syn¬
dromes
or
history
of
syncope
due
to
car¬
diac
causes
should
be
excluded.18
Obese
individuals
show
a
linear
increase
in
QTc
with
increasing
obesity.116
While
stud¬
ies
have
generally
demonstrated
either
no
change
or
a
shortening
of
preexisting
QTc
prolongation
with
weight
loss,117
car¬
diac
consultation
should
be
considered
in
asymptomatic
patients
with
QTc
in¬
terval
more
than
0.44
msec
before
start¬
ing
a
VLCD.
The
QTc
should
be
mon¬
itored
frequently
in
these
patients,
as
should
electrolyte
levels,
during
both
the
VLCD
and
refeeding
periods.
Med¬
ications,
including
phenothiazines
and
tricyclic
antidepressants,
which
length¬
en
QT
intervals,
should
be
used
with
extreme
caution
in
patients
on
VLCDs.
Cerebrovascular
Disease.—Recent
or
recurrent
cerebrovascular
accidents
and/
or
transient
ischemie
attacks
are
con¬
traindications
to
use
of
VLCDs,
due
to
the
potential
adverse
effects
of
hypoten¬
sion
and/or
dehydration
on
vascular
perfusion.75·118
For
similar
reasons,
the
risk-benefit
ratio
should
be
carefully
evaluated
in
patients
with
recent
or
re¬
current
thromboembolic
disease.
Renal
Disease.—Creatinine
clearance
should
be
evaluated
in
patients
with
el¬
evated
creatinine
or
serum
urea
nitro¬
gen
on
preliminary
evaluation.
Very
low-
calorie
diets
should
be
avoided
if
signif¬
icantly
decreased
renal
function
is
doc¬
umented,
because
adequate
kidney
function
is
necessary
for
excretion
of
the
protein
catabolic
load,
diuresis,
and
electrolyte
balance.75
Weight
loss
in
such
patients
should
be
approached
conser¬
vatively
and
under
the
careful
control
of
a
physician.
Hepatic
Disease.—Very
low-calorie
diets
should
not
be
used
in
patients
with
severe
or
end-stage
liver
disease.
How¬
ever,
asymptomatic
elevations
in
ami¬
notransferase
levels
are
common
in
the
obese,
probably
secondary
to
fatty
liv¬
er,
and
do
not
contraindícate
use
of
VLCDs.
These
elevations
are
generally
mild119
and
frequently
normalize
with
weight
loss.120
More
serious
elevations
of
aminotransferase
levels,
symptoms
or
signs
of
liver
disease,
or
other
evi¬
dence
of
impaired
hepatic
function
should
prompt
the
search
for
other
etiologies
and
avoidance
of
VLCDs
to
achieve
weight
loss.
Psychiatric
Disorders.—Patients
with
a
history
of
bulimia
nervosa
or
an¬
orexia
nervosa
should
not
be
permitted
to
undergo
VLCDs.121
Such
patients
present
dangers
of
vomiting
and
diuret¬
ic
or
laxative
abuse,
with
potential
elec¬
trolyte
abnormalities.
Patients
with
a
current
or
recent
history
of
alcohol
or
other
drug
abuse
are
generally
unsuit¬
able
for
VLCDs
and
often
have
difficul¬
ties
with
compliance.121
Very
low-calo¬
rie
diets
must
be
used
with
caution
in
patients
with
a
history
of
major
depres¬
sion
or
suicide
attempts
and
should
not
be
used
if
the
patient
is
currently
ex¬
periencing
an
episode
of
major
depres-
by guest on July 17, 2009 www.jama.comDownloaded from
sion.121
Patients
under
psychiatrie
care
or
on
psychotropic
medications
must
be
stable
and
should
have
the
approval
of
their
therapist
before
undertaking
a
VLCD.
These
diets
should
be
used
with
caution
with
patients
who
have
a
diag¬
nosis
of
a
psychotic
disorder,
or
in
whom
follow-up
may
be
problematic.
While
there
is
evidence
that
dieting
is
not
as
closely
linked
to
binge
eating
as
to
bu¬
limia
nervosa,122
patients
who
have
dif¬
ficulties
with
binge
or
episodic
overeat¬
ing
may
experience
difficulties
in
ad¬
herence
to
LCD
or
VLCD
programs.123
Type
I
(Insulin-Dependent)
Diabe¬
tes
Mellitus.—Because
of
the
potential
for
severe
ketosis
and/or
hypoglycemia,
VLCDs
should
be
used
with
caution
and
close
medical
monitoring
in
ketosis-prone
diabetics.
Ketosis
should
be
controlled
prior
to
institution
of
the
diet.18
More
conservative
weight
loss
methods
may
be
preferred
in
this
population.
Other
Medical
Conditions
Requiring
Special
Caution
During
VLCD
There
is
some
evidence
that
large
weight
losses
may
increase
the
proba¬
bility
of
developing
acute
cholecystitis.
The
risks
of
VLCDs
in
patients
with
known
gallstones
or
a
history
of
chole¬
cystitis
must
be
carefully
weighed
against
the
benefits
of
weight
loss
prior
to
sur¬
gery.
Patients
with
type
II
(non-insulin-
dependent)
diabetes
mellitus
generally
do
well
on
VLCDs.
However,
to
avoid
significant
risk
of
hypoglycemia,
patients
on
oral
hypoglycémies
or
insulin
must
be
trained
in
home
blood
glucose
monitor¬
ing,
and
medications
should
generally
be
reduced
or
discontinued
at
the
beginning
of
the
VLCD.
Medications
in
hyperten¬
sive
patients
may
often
be
decreased
or
discontinued
shortly
after
beginning
a
weight
loss
program.
Because
of
the
dan¬
gers
of
hypotension
and
electrolyte
ab¬
normalities,
diuretics
should
be
discon¬
tinued
before
beginning
the
diet.118
Pa¬
tients
with
a
history
of
gout
may
be
start¬
ed
or
continued
on
medication
to
decrease
hyperuricemia,
but
those
with
asymp¬
tomatic
hyperuricemia
of
less
than
590
µ /L
(10
mg/dL)
do
not
generally
re¬
quire
medication
during
the
VLCD.
Pa¬
tients
on
VLCD
should
usually
postpone
elective
major
surgical
procedures
for
at
least
1
month
following
refeeding,
so
that
adequate
nutrition
can
be
restored.
How¬
ever,
the
theoretical
risks
of
undergoing
surgery
while
in
a
catabolic
state
must
be
weighed
against
the
needs
for
more
immediate
surgery.
GUIDELINES
FOR
MEDICAL
MONITORING
While
current
VLCDs
are
safe
when
used
as
directed
with
carefully
selected
patients,
appropriate
medical
supervi¬
sion
and
surveillance
are
necessary
to
minimize
adverse
outcomes.
Physicians
who
supervise
a
patient's
care
during
VLCDs
should
be
knowledgeable
about
the
indications
and
contraindications
for
their
use,
potential
adverse
reactions,
and
medication
interactions.
Initial
Evaluation
Patients
should
receive
a
thorough
medical
evaluation
before
undertaking
a
VLCD.
The
evaluation
should
include
both
a
comprehensive
medical
history
and
physical
examination,
as
well
as
an
obesity-specific
component,
determining
weight
history,
dietary
intake,
and
de¬
gree
of
medical
risk
posed
by
obesity.124
The
patient's
motivation
for
and
com¬
mitment
to
treatment
should
be
as¬
sessed,
and
expectations
of
both
physi¬
cian
and
patient
addressed.
Little
information
is
available
that
doc¬
uments
the
necessity
for
specific
labo¬
ratory
tests
prior
to
undergoing
a
VLCD.
The
following
tests
will
provide
sufficient
information
on
most
conditions
that
have
an
impact
on
treatment:
a
com¬
plete
blood
cell
count,
to
uncover
ane¬
mia
or
hématologie
disease;
serum
elec¬
trolytes,
to
exclude
abnormalities
such
as
hypokalemia
or
metabolic
alkalosis
that
would
suggest
the
diagnosis
of
bu¬
limia
nervosa;
alanine
aminotransferase
and
aspartate
aminotransferase,
alka¬
line
phosphatase,
and
total
bilirubin,
to
exclude
significant
underlying
liver
disease;
serum
urea
nitrogen
and
cre¬
atinine
to
document
renal
function;
a
fasting
or
postprandial
blood
glucose
to
screen
for
diabetes
mellitus
in
this
high-
risk
population;
and
uric
acid
to
assess
the
need
for
prophylactic
medication
in
patients
with
high
levels
(ie,
>590
µ /L
[10
mg/dL])
or
in
patients
with
a
history
of
gout.
For
women
of
childbearing
age
en¬
tering
a
VLCD
program,
a
pregnancy
test
should
be
performed
and
the
ade¬
quacy
of
birth
control
assessed.
Patients
should
be
advised
that
fertility
may
in¬
crease
with
weight
loss.
Finally,
an
electrocardiogram
and
rhythm
strip
should
be
obtained
to
seek
evidence
of
abnormal
cardiac
function,
dysrhythmias,
or
prolonged
QT
interval.
Medical
Surveillance
During
VLCD
A
physician
with
specialized
training
in
the
use
of
VLCDs
and
a
supervising
physician
for
medical
consultation
should
be
available
to
the
patient
throughout
the
treatment
program.
Medical
person¬
nel
should
be
alert
to
signs
or
symptoms
associated
with
rapid
weight
loss,
such
as
dizziness
(orthostasis),
abdominal
pain
(cholecystitis,
constipation),
or
joint
pain
(gout).
Patients
with
concomitant
med¬
ical
conditions,
such
as
diabetes
or
hy¬
pertension,
especially
if
on
medications,
will
require
frequent
physician
contact
during
the
modified
fast.
At
a
minimum,
all
patients
should
have
their
weight,
pulse,
and
blood
pressure
assessed
ev¬
ery
week
to
2
weeks
during
the
course
of
the
modified
fast
and
during
refeed¬
ing.
It
is
also
recommended
that
pa¬
tients
undergo
clinical
cardiovascular
as¬
sessment
during
refeeding,
since
the
risks
of
cardiac
dysrhythmias
are
in¬
creased
during
this
period.
Current
VLCD
formulations
usually
contain
appropriate
vitamins
and
min¬
erals,
making
serious
abnormalities
un¬
usual.
Very
low-calorie
diets
using
food
sources
(eg,
lean
meat,
fish,
fowl)
will
require
additional
supplementation.
There
is
little
information
document¬
ing
the
necessity
for
routine
laboratory
monitoring
during
VLCD.
Nonetheless,
it
is
prudent
to
check
serum
electrolyte
levels
during
the
first
2
weeks
of
the
VLCD,
when
initial
diuresis
would
be
most
likely
to
produce
abnormalities,
and
again
during
refeeding.
Other
lab¬
oratory
evaluation
should
be
performed
as
medically
indicated.
CONCLUSIONS
For
the
vast
majority
of
overweight
Americans,
who
are
only
mildly
obese,
a
balanced
LCD
combined
with
a
pro¬
gram
of
exercise
and
behavior
modifi¬
cation
remains
the
treatment
of
choice.
For
those
who
are
more
severely
obese,
a
VLCD
can
be
effective
in
producing
significant
short-term
weight
loss
and
rapid
improvement
in
weight-related
medical
conditions.
Current
formulations,
which
usually
contain
protein
of
high
biologic
value
and
adequate
calories,
are
generally
safe
when
properly
used
in
selected
patients
with
appropriate
medical
supervision.
Most
adverse
reactions
are
minor
and
well
tolerated.
The
most
serious
com¬
plication
associated
with
current
VLCDs
is
symptomatic
cholelithiasis.
Very
low-calorie
diets
should
gener¬
ally
be
used
only
in
patients
with
a
BMI
greater
than
30.
Use
of
VLCDs
in
pa¬
tients
with
a
BMI
of
27
to
30
should
be
reserved
for
those
who
have
medical
complications
resulting
from
their
obe¬
sity
(such
as
hypertension
or
diabetes)
and
who
have
been
unsuccessful
with
conventional
LCDs.
The
VLCD
formu¬
lation
should
contain
a
minimum
of
1
g/kg
of
IBW
per
day
of
high
biologic
value
protein.
No
advantage
has
been
demonstrated
by
the
use
of
formulations
with
an
energy
level
below
3350
kJ/d
(800
kcal/d
or
approximately
12
kcal/kg
of
IBW
per
day),
and
there
are
few
pub¬
lished
data
on
the
safety
of
exclusive
by guest on July 17, 2009 www.jama.comDownloaded from
use
of
VLCDs
for
longer
than
16
weeks.
All
patients
undergoing
VLCDs
should
have
a
thorough
initial
evaluation
by
a
physician.
Severely
obese
patients
fre¬
quently
have
underlying
medical
prob¬
lems
that
will
require
careful
monitor¬
ing
during
VLCD
treatment.
The
fre¬
quency
and
intensity
of
continued
sur¬
veillance
during
the
VLCDs
should
be
dictated
by
clinical
judgment.
Controlled
trials
have
shown
that
VLCDs
combined
with
behavior
modi¬
fication
strategies
result
in
greater
weight
loss
and
slower
regain
than
VLCDs
used
alone.
Moreover,
the
com¬
bination
of
VLCDs
and
exercise
pro¬
motes
long-term
maintenance
of
weight
loss.
Thus,
VLCDs
should
be
offered
in
the
context
of
comprehensive
programs
that
provide
nutrition
education,
an
ex¬
ercise
program,
and
behavioral
thera¬
py.
Ideally,
these
programs
should
be
staffed
by
professionals
with
specialized
training
in
these
disciplines.
Long-term
maintenance
of
weight
loss
with
VLCD,
as
with
all
obesity
treat¬
ments
currently
available,
remains
dis¬
appointing.
Even
with
VLCD
programs
that
contain
all
suggested
components,
many
patients
will
regain
their
lost
weight
within
5
years.
For
most
indi¬
viduals,
obesity
is
a
chronic,
lifelong
dis¬
order
requiring
ongoing
care.
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is
no
evidence
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use
of
VLCDs
will
lead
to
any
greater
long-term
weight
loss
than
other
dietary
treatments.
There¬
fore,
patients
should
be
encouraged
to
participate
in
long-term
supportive
treatment
after
the
initial
weight
re¬
duction
phase
is
completed,
and
to
focus
on
changes
in
lifestyle
and
behavior
that
will
be
most
conducive
to
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of
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