MODIFIED FAST:  A SOMETIME SOLUTION TO A WEIGHTY PROBLEM

Overweight is a hefty problem in the United States. It's estimated that 24
percent of men and 27 percent of women in this country about 34 million 
adult Americans are obese. And  sometimes it seems that there are 34 million
different diets or diet products promoted to combat the problem.  The latest
to win the nation's fervent attention is a revival of a sort return to very 
low calorie diets, generally 400 to 800 calories per day. 

Very low calorie, or modified fasting, diets, as they are sometimes called, 
are not a new concept.  Protein formula products (either liquid or powdered)
were popular more than a decade ago until serious health effects including
several deaths dampened the public's enthusiasm and led to new federal
requirements for labeling of these products (see accompanying article,
Protein Diet Warning).

                          New Product, New Program

The modified fast regimen is enjoying renewed popularity, but today's very
low calorie diet products differ markedly in both content and use from those
of the past.  While many of the formulas of the 70s were directly available 
to consumers through supermarkets and other retail outlets, the newer 
products are sold only to doctors or hospitals for use in medically 
supervised programs that include frequent medical examinations and behavior 
modification training.

Some dieters using the old products subsisted on as few as 300 calories per 
day of a nutritionally deficient product consisting primarily of a
poor-quality protein (usually a hydrolyzed gelatin). Unlike the old diet
formulas, today's Optifast, Medifast, HMR, and similar products contain a 
high-quality protein (egg white- or milk-based), carbohydrates, and some fat
and are supplemented to meet recommended dietary allowances for vitamins, 
minerals and electrolytes.  They are not a panacea, however, and, as the
American Dietetic Association recently warned, they are not for everyone. 

The comeback of very low calorie diets had been fairly quiet until last 
winter, when they were catapulted into the limelight by talk show host Oprah
Winfrey.  With some flair, Winfrey demonstrated on national television how
she won the battle of the bulge with Optifast.  Carting 67 pounds of animal 
fat on the television set to dramatize how much extra weight she had been 
carting around in her body pre-Optifast, Winfrey made quite an impact on her
viewers and many more of the nation's dieters who learned about her 
transformation from newspapers, magazines, television, and radio. 

                         That Lean and Healthy Look 

Shedding that 67 pounds not only took inches from Winfrey's torso, it may 
add years to her life as well.  For the problem of obesity is not simply a
matter of whether a ?slim, svelte look is or is not more appealing than one 
that's pleasingly plump.  Observations from the famous Framingham Heart 
Study, in which several thousand members of the small Massachusetts town
have been followed medically since 1948, have shown that a 20 percent excess
over ideal weight constitutes a health risk.

Overweight has been linked to a long list of health problems high blood 
pressure, respiratory problems, nighttime sleeplessness and (resulting
daytime sleepiness), heart disease, diabetes mellitus, elevated blood 
lipids, gallstones, arthritis, and some cancers including that of the 
breast, endometrium and gallbladder in women, and colon, rectum and prostate
in men. 

Like Winfrey, Karen, who asked that her real name not be used, has been 
battling the bulge for years.  A 41-year-old registered nurse, Karen has
been on one diet or another almost continuously since she was 15 years old, 
losing and regaining pounds for 26 years. 

                                 The Program

And, like Winfrey, Karen lost 67 pounds on Optifast. Hers was a 20-week 
program that consisted of 12 weeks of fasting, six weeks of refeeding, and
two weeks of maintenance.  During the fasting phase, Karen subsisted on five
packets a day of an 85-calorie powder formula reconstituted with water or a 
very low calorie diet beverage with no sodium or caffeine. She also took a
potassium supplement daily. (An 800-calorie diet is prescribed for some 
people for example, for medical reasons or for very active overweight men 
who require more calories to get through the day.)  Solid food was gradually
introduced over the next six weeks, and the final two weeks were devoted to 
maintaining weight.  Karen had blood tests done every other week throughout 
the program to check sodium, potassium, and other blood chemistries, and an 
electrocardiogram once a month to check for heart abnormalities.

Also integral to the program and mandatory was nutrition education and
behavior modification training with a psychological component to help 
overeaters examine why they overeat and how they can replace their food 
dependency with other pleasurable activities, such as exercise, reading, or 
listening to music.  The program has been modified slightly since Karen took
it three years ago, but it and other medically supervised very low calorie
diet programs remain similar in content, calories, recommended length of
use, and cost.

A 67-pound weight loss in 20 weeks sounds pretty good, doesn't it.  But 
before you lace up your running shoes to dash out and sign yourself up, 
consider the following the program may not be for you. To begin with, you 
may be screened out.  You must be a certain amount overweight; in Karen's 
program, entry criteria are at least 50 pounds or 30 percent over ideal 
weight.  People with a history of certain medical problems such as liver or 
kidney disease, heart failure, cancer or Type I (insulin-dependent) diabetes
may not be accepted.  Even if you qualify, when you learn the cost, you may 
want to screen yourself out the range is generally from $100 to $150 a week.
This includes all aspects of the program the formula, supplements, medical
exams, and behavior modification training.

And then there's the C word commitment.  In a recent issue of the 
International Journal of Obesity, Marvin A. Kirschner, M.D., and his
colleagues at Newark Beth Israel Medical Center, N.J., reported that of 
4,026 morbidly obese patients (at least 100 pounds over ideal weight) who 
began the Optifast program, one-fourth dropped out within the first three 
weeks.

                            Results: Good and Bad 

What about the 3,020 men and women who stuck it out?  Sixty-eight percent 
lost considerable weight but did not reach their goal, and only 5 to 10 
percent of them had maintained the weight loss after 18 months. The 32
percent who attained their goal by program's end proved to have greater 
staying power; 30 percent of the women and 58 percent of the men kept off 
the pounds for at least 18 months.

Kirschner and colleagues reported lightheadedness and tiredness as the most 
common complaints among dieters early on in the fast.  The most common late 
complaint was a mild transient hair loss, experienced by about 10 percent of
the participants.  There were two cases of acute gout; two cases of foot
drop, which the authors speculate were due to sciatic nerve compression from
leg crossing during or after weight loss; and four cases of acute 
psychosis.  One patient developed a rapid heartbeat due to low blood sugar, 
which was corrected with intravenous glucose, and two patients were 
hospitalized for irregular heartbeats.

Other known adverse side effects of rapid weight loss include cold
intolerance, dry skin, constipation, potassium deficiency, excess uric acid 
in the blood, gallbladder inflammation, and psychological changes ranging 
from elation to depression. 

On the positive side, Kirschner and colleagues found that complications of
obesity among the group including high blood pressure, Type II diabetes 
mellitus, and elevated blood lipids improved markedly.  Unexplained sudden
deaths, such as occurred with use of protein products in the 1970s, have not
been reported with use of the improved formulas.

The American Dietetic Association is cautious about fasting diets,
nevertheless.  In a statement released in May 1989, the association noted 
the serious health hazards posed by very low calorie diets and warned that
they should be undertaken only with the supervision of a multidisciplinary
health team that includes monitoring by a physician and nutrition counseling
by a registered dietitian.

According to the association, very low calorie diets have poor long-term
results:  Evidence shows that a high percentage of dieters regain over half 
the weight lost in the program.  To improve these statistics, the 
association encourages follow-up with continued nutrition counseling, 
increased aerobic exercise, relaxation techniques, and behavior modification. 

                       Behavior Therapy Key to Success

In a study of 59 subjects, Thomas A. Wadden, M.D., and Albert J. Stunkard,
M.D., of the University of Pennsylvania School of Medicine compared the 
effectiveness of three different weight-loss regimens: very low calorie (400
to 500 calories) diet alone, behavior therapy with a 1,000- to 1,200-calorie
diet, and very low calorie diet plus behavior therapy. After following the
dieters for one year, they concluded that:

Weight is regained rapidly after treatment by very low calorie diet alone.

Behavior therapy produces favorable long-term results when used with either 
a conventional 1,200-calorie diet or a very low calorie diet. 

Weight lost in behavioral treatment is associated with improved 
psychological functioning.

Karen knows well the problem of regaining weight. According to her, getting 
the weight off is not the issue. ?Most very heavy people have gained and
lost weight millions of times, she says. They know how to lose weight. They 
don't know how to maintain weight.

She describes the refeeding phase of the Optifast program as a type of
re-entry process.  Okay, now you're allowed a little bit of food, she says, 
and then you're opening the refrigerator again and you've got to start
making choices you've got to deal with all that again.  She, too, believes
that the emphasis in any low-calorie program must be on maintaining the 
loss.  The program she took provided 14 weeks of relapse-prevention classes 
at the end of the 20-week diet. 

So how has she fared up till now three years after the program?  Of the 18
people who started in my group, only five finished, she recalls.  Only three
of the five went to relapse prevention, and I was the only one who stuck it 
out to the end. 

Karen regained 6 pounds almost immediately after beginning maintenance; that
is, when she began eating three meals a day and calculating on her own.  I
maintained the remaining 61-pound loss for a good while I'd say a year and a
half and then I got sloppy, she says.  Up until then, she had been religious
about writing down every morsel of food that went in my mouth, drinking two 
quarts of water a day, exercising daily.

Karen has gained back a total of about 18 pounds most of them after she quit
smoking a few months ago and is back to rigorous dieting, but not fasting.
She says she exercises daily, eats the amount of calories she was instructed
to eat, drinks two quarts of water a day, and is gaining weight anyway. She 
says, I'm concerned about my ability to lose weight on food again.

                             The Yo-Yo Syndrome 

No one debates that maintaining weight loss is a bigger problem than taking 
the pounds off. One theory holds that the body's survival mechanism for 
protecting against starvation contributes to the difficulty in keeping slim.
Strenuous dieting causes the body's metabolism to slow down in order to 
maintain vital functions. When caloric intake increases, metabolism speeds
up again. 

Some research indicates that repeatedly losing and regaining weight can lead
to permanent damage to metabolism, resulting in the so-called yo-yo effect a
vicious cycle whereby the more you diet, the slower your metabolism becomes 
and you must eat even less in order to maintain weight loss.

Another theory is that each person has a control system that sets how much
weight, or fat, he or she should have. This set point theory holds that our 
bodies are programmed to level off at a certain weight, and no matter how 
much we lose, the set point will bring us back up to our original weight
once we stop dieting. 

Whether or not these theories are eventually proven to be scientifically
valid, most experts agree that crash diets for a few days or weeks
accomplish little of permanent value and that for a diet to be successful in
the long term, it must be tailored to the individual patient (see 
accompanying article, Going It Alone).

As for Karen, she says, I know the statistics are abysmal.  But I think 
what's important is to not say you're finished.  It's important when you
lose weight on a diet never to say, Phew! I've got that beat, because you 
don't.

Marian Segal is a member of FDA's public affairs staff. 

Sidebar 1 

WARNING: Very low calorie protein diets (below 400 Calories per day) may
cause serious illness or death. Do Not Use for Weight Reduction in Such 
Diets Without Medical Supervision. Not for use by infants, children, or 
pregnant or nursing women.

In the spring of 1984 the Food and Drug Administration published a final
rule in the Federal Register requiring that the above warning appear on 
protein products promoted for weight reduction. 

The new regulation grew out of numerous reports of deaths associated with 
the use of very low calorie weight reduction regimens beginning in the late 
1970s. An investigation by FDA and the federal Centers for Disease Control
revealed a pattern of sudden death or death from irreversible abnormal heart
rhythms in people who had been dieting for prolonged periods and had lost 
large amounts of weight.

Of the first 58 reports, 17 deaths were of relatively young people (average 
age 35 years) who had no underlying disease to which the deaths could have
been attributed. Six of the dieters died suddenly, six died in the hospital 
(having been admitted after fainting), and five nonhospitalized dieters 
suffered cardiac arrest.

In 13 of the cases, the dieters total caloric intake came solely from a 
liquid collagen or gelatin protein solution.  Two patients supplemented 
their liquid protein once a day with a high-quality protein food. The 
remaining two used powdered products of a high-quality protein, one 
containing mineral supplements. 

No single brand product was used by more than two individuals.  The daily 
caloric intake for all dieters was from 300 to 400 calories, and all took a 
vitamin or vitamin-mineral supplement. Twelve of the dieters were under some
form of medical supervision, ranging from thorough to infrequent follow-ups 
without laboratory tests. 

In December 1977, FDA first proposed to require warnings on the labels and
labeling of protein products for weight reduction, and the following
December a tentative final rule was published in the Federal Register. The
final rule, requiring three different warnings for protein products deriving
more than 50 percent of their total caloric value from protein, was 
published in April 1980.

A month after publication, the Council for Responsible Nutrition a trade
association whose membership includes manufacturers of dry, whole-protein 
products filed suit to invalidate the labeling regulations.  Although the 
court upheld FDA's overall labeling plan, it decided against the agency,
finding insufficient evidence to support FDA's finding that diets between 
400 and 800 calories per day may cause serious illness or death.  So, the 
court ordered the regulation back to FDA for further study and reformulation. 

In the Federal Register of June 11, 1982, FDA proposed a revised rule for 
protein product labels. After reviewing comments received in response to the
new proposal, a final rule was developed. It became effective Aug. 6, 1984. 
The rule concerned label requirements for any food product in liquid, 
powdered, tablet, capsule, or similar form that derives 50 percent of its 
total caloric value from either whole protein, protein hydrolysates, amino
acid mixtures, or a combination of these, and that is . . . promoted for use
to reduce weight. 

Protein products are exempt from the labeling requirements if the product is
represented as part of a nutritionally balanced diet plan providing 400 or
more calories per day and the label specifies the diet plan in detail or
briefly describes the plan and provides information on where it can be
obtained.  In this case, the label must bear the following statement: 
NOTICE:  For weight reduction, use only as directed in the accompanying diet
plan (the name and specific location in labeling of the diet plan may be
included in this statement in place of accompanying diet plan). Do not use
in diets supplying less than 400 calories per day without medical 
supervision.

FDA, as a regulatory agency, does not formally approve diet plans. Unlike 
drugs, foods do not require pre-market approval.  An agency talk paper
released Dec. 30, 1982, in response to inquiries about the safety of
extremely low calorie diets, stated that There is a general consensus among 
nutrition and obesity control experts that extremely low calorie diets diets
providing less than 400 calories per day are physiologically unsound
regardless of their overall nutrient composition. 

The paper further stated that there is also a consensus among these experts 
that diets providing less than 800 calories per day should be used only 
under proper medical supervision, and that FDA concurs with the consensus.

M.S.

Sidebar 2 

                               Going It Alone 

FDA's division of nutrition deputy director Victor Frattali, Ph.D., is wary 
of fasting diets in general. He is especially concerned, however, about 
dieters who use very low calorie diet products without medical supervision. 
He says there are two critical factors to consider in very low calorie
diets: the quality of the product and the directions for use.  The powder or
liquid in the newer products that are sold directly to consumers may or may 
not provide all the nutrients you need, says Frattali, but even if they do, 
I have serious concerns about diets of less than 800 calories per day.

FDA's position is that diets of less than 800 calories a day should be
undertaken only with proper medical supervision, and Frattali maintains 
that, in fact, almost anyone can lose weight on 1,200 calories a day. 

Nutritionist Marilyn Stephenson of FDA?s Office for Nutrition and Food
Sciences says a reasonable goal for weight reduction is to lose a pound or
so a week. To lose one pound of fat a week, food consumption must be reduced
by 500 calories a day.

A 1,000- to 1,200-calorie-per-day diet should be combined with increased
physical activity, which raises your metabolism, [burns more] calories, and 
improves physical fitness, Stephenson advises.  For many people, simply 
eating smaller portions of the foods usually eaten, keeping fried and other 
fatty foods and rich desserts to a minimum, and exercising more is an 
appropriate approach to weight loss and weight maintenance. 

Stephenson also advises consulting a physician and then, if possible, a 
nutritionist or dietitian before beginning a diet.  This is especially
prudent for people who have a medical condition or have many pounds to
lose.  Certain diets pose serious health hazards for people with some 
diseases such as diabetes or intestinal disorders. (For more on diets and 
weight loss, see Diet Books Sell Well but . . . in the March 1982 FDA 
Consumer.)

--M.S.