Category Archives: Weight Loss

Weight-Loss Drug Meridia Pulled From U.S. Market

MedPageToday reported October 8, 2010, that Abbott is voluntarily removing Meridia from the U.S. market. I had written on October 8 about the higher incidence of stroke and heart attack in Meridia users who had underlying cardiovascular disease.

Meridia, also known as sibutramine, has an estimated 100,000 users in the U.S. Abbott recommends that they stop taking the drug and consult their physicians about other weight-loss programs.

Here are a some options I like:

  1. Advanced Mediterranean Diet
  2. Ketogenic Mediterranean Diet
  3. Low-Carb Mediterranean Diet

This would be a good time for Meridia ex-users to review “Prepare For Weight Loss.”

Steve Parker, M.D.

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Heart and Stroke Patients: Avoid Weight-Loss Drug Sibutramine (Meridia)

The weight-loss drug sibutramine (Meridia) should be withdrawn from the U.S. market, suggests an editorialist in the September 2, 2010, New England Journal of Medicine.  Based on a clinical study in the same issue, it’s more accurate to conclude that sibutramine shouldn’t be prescribed for people who aren’t supposed to be taking it in the first place.

Sibutramine is sold in the U.S. as Meridia and has been available since 1997.  Judging from the patients I run across, it’s not a very popular drug.  Why not?  It’s expensive and most people don’t lose much weight.

The recent multi-continent SCOUT trial enrolled 9,800 male and female study subjects at least 55 years old (average age 63) who had either:

  1. 1) History of cardiovascular disease (here defined as coronary artery disease, stroke, or peripheral artery disease)
  2. 2) Type 2 diabetes plus one or more of the following: high blood pressure, adverse cholesterol levels, current smoking, or diabetic kidney disease.
  3. Or both of the above (which ended up being 60% of the study population)`.

Here’s a problem from the get-go (“git-go” if you’re from southern U.S.).  For years, Meridia’s manufacturer and the U.S. Food and Drug Administration have told doctors they shouldn’t use the drug in patients with history of cardiovascular disease.  It’s not the scary “black box warning,” but it’s clearly in the package insert of full prescribing information.

Half the subjects were randomized to sibutramine 10 mg/day and the other half to placebo.  All were instructed in diet and exercise aiming for a 600 calorie per day energy deficit.  They should lose about a pound a week if they followed the program.  Average follow-up was 3.4 years.

What Did the Researchers Find?

Forty percent of both drug and placebo users dropped out of the study, a very high rate.

As measured at one year, the sibutramine-users averaged a weight loss of 9.5 pounds (4.3 kg), the majority of which was in the first 6 weeks.  After the first year, they tended to regain a little weight, but kept most of it off.

Death rates were the same for sibutramine and placebo.

Sibutramine users with a history of cardiovascular disease had a 16% increase in non-fatal heart attack and stroke compared to placebo.  To “cause” one heart attack or stroke in a person with known cardiovascular disease, you would have to treat 52 such patients.

Folks in the “diabetes plus risk factor(s)” group who took sibutramine had no increased risk of heart attack or stroke.

So What?

Average weight loss with sibutramine isn’t much.  Nothing new there.  [Your mileage may vary.]

People with cardiovascular disease shouldn’t take sibutramine.  Nothing new there either.

Steve Parker, M.D.

Reference:  James, W. Philip, et al.  Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.  New England Journal of Medicine, 363 (2010): 905-917.

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Filed under coronary heart disease, Drugs for Diabetes, Overweight and Obesity, Stroke, Weight Loss

2002 Atkins Diet at a Glance

Dr. Robert C. Atkins is the modern popularizer of low-carb dieting.  He was neither the first nor only low-carb advocate of the 20th century, but certainly the most influential in modern history in terms of followers.  His Dr. Atkins Diet Revolution was published in 1972 and sold millions of copies. 

Sir Isaac Newton wrote in 1676: “If I have seen further, it is by standing on the shoulders of giants.”  Twentieth century giants for Dr. Atkins include Frank Evans, Blake Donaldson (the original paleo diet guru?), Per Hansen, Alfred Pennington, and John Yudkin.  Most of these were physicians, by the way.  William Banting preceeded them, in the 19th century.

Dr. Atkins New Diet Revolution, published in 2002, was a huge seller then and maintains a respectable sales volume even now.  My impression is that Atkins Nutritionals, Inc., has replaced it with The New Atkins for a New You, which I reviewed last spring.  Enough people still follow DANDR that I need to stay familiar with it.  Here’s my brief summary of the phases.

Induction or Phase 1

  • Limit carbs to 20 g of “net carbs” daily for a minimum of two weeks.
  • “Net carbs” is the total carb count in grams, minus the fiber grams.
  • 3 cups of salad greens daily with olive oil/vingar or lemon juice OR 2 cups of salad greens and one cup of non-starchy cooked vegetables (e.g., broccoli or zucchini).
  • May also eat 3–4 ounces of aged cheese, a handful of olives, and half an avocado daily.

Ongoing Weight Loss (OWL) or Phase 2

  • Deliberate slowing of weight loss.
  • Gradually add back nutrient-rich carbs.
  • Increase net carbs weekly by just 5 g, by eating more veggies, nuts, seeds, even berries (this is where the “carb ladder” comes into play, adding carb groups in a specific order).
  • Some dieters can even add small amounts of beans and fruits other than berries, until weight loss stalls.  At that point, you drop back 5 g net carbs, to your Critical Carbohydrate Level for Losing (CCLL).

Pre-maintenance or Phase 3

  • Begins 5 or 10 pounds before reaching your weight goal.
  • Weight loss slows even more, taking at least 2 months to lose that last 10 pounds.
  • Can now add some starchy veggies like sweet potatoes, peas, whole grains.
  • If weight loss stops before goal, drop back down by 5-10 g net carbs, to your revised CCLL.

Lifetime Maintenance or Phase 4

  • Starts when you’ve been at goal weight for one month.
  • No more junk food, ever.
  • Stay vigilant for excessive carbs.  You may never be able to go back to whole grains or higher-carb fruits and vegetables.

Steve Parker, M.D.

PS: Gary Taubes reviews the history of low-carb diets in his masterpiece, Good Calories, Bad Calories.

Sir Isaac Newton
Head and shoulders portrait of man in black with shoulder-length gray hair, a large sharp nose, and an abstracted gaze

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Is a Low-Carb Diet Safe For Obese Adolescents?

High-protein, low-carbohydrate diets are safe and effective for severely obese adolescent, according to University of Colorado researchers.

Childhood obesity in the U.S. tripled from the early 1980s to 2000, ending with a 17% obesity rate.  Overweight and obesity together describe 32% of U.S. children.  Some experts believe this generation of kids will be the first in U.S. history to suffer a decline in life expectancy, related to obesity.

Colorado researchers wondered if a low-carb, high-protein diet is a reasonable treatment option.  Why high protein?  It’s an effort to preserve lean body mass (e.g., muscle). 

ResearchBlogging.orgThey randomized 46 adoloscents (age 12–18) to either a high-protein, low-carb diet (HPLC diet) or a calorie-restricted low-fat diet to be followed for 13 weeks.  HPLC dieters could eat unlimited calories as long as they attempted to keep carb consumption to 20 g/day or less.  Low-fat dieters were to choose lean protein sources, aiming daily for 2 to 2.5 grams of protein per kilogram of ideal body weight.  Study participants underwent blood analysis and body compositon analysis by dual x-ray absorptiometry.  These kids weighed an average of 108 kg (238 lb) and average body mass index was 39. 

Analysis of food diaries showed the following:

  • Average caloric intake was 1300-1450/day, toward the lower end for the HPLC dieters
  • Energy composition of the HPLC diet: 32% from protien, 11% from carb, 57% from fat
  • Energy compositon of the LF diet: 21% from protein, 51% from carb, 29% from fat
  • Average daily carb consumption for the HPLCers ended up closer to 40 g (still very low) 

Findings

Both groups lost weight, with the HPLC dieters trending to greater weight loss, but not to a statistically significant degree.  They did, however, show a greater drop in body mass index Z-score, however.  Study authors didn’t bother to explain “body mass index Z-scores,” assuming I would know what that meant.  Average weight in the HPLC group dropped 13 kg (29 lb) compared to 7 kg (15 lb) in the low-fat group.

Total and LDL cholesterol fell in both groups, and insulin resistance improved.  Neither diet had much effect on HDL cholesterol.

As usual, triglycerides fell dramatically in the HPLC dieters.

Nearly 40% of the kids—about the same number in both groups—dropped out before finishing the 13 weeks.

The HPLC group did not see any particular preservation of lean body mass, and actually seemed to lose a bit more than the low-fat group.

There were no serious adverse effects in either group. 

Surprisingly, satiety and hunger scores were the same in both groups.  [Low-carb, ketogenic diets have a reputation for satiation and hunger suppression.]

My Comments

This is a small short-term study with a large drop-out rate; we must consider it a pilot study.  That’s why I’m not as enthusiastic about it as the researchers.  Nevertheless, it does indeed suggest that high-protein, low-carb diets are indeed safe and effective in obese adolescents.  It’s a start.   

Steve Parker, M.D.

Reference: Krebs, N., Gao, D., Gralla, J., Collins, J., & Johnson, S. (2010). Efficacy and Safety of a High Protein, Low Carbohydrate Diet for Weight Loss in Severely Obese Adolescents The Journal of Pediatrics, 157 (2), 252-258 DOI: 10.1016/j.jpeds.2010.02.010

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Filed under Carbohydrate, Fat in Diet, ketogenic diet, Protein, Weight Loss

Low-Fat and Low-Carb Diets End Battle in Tie After Two Years, But…

Dieters on low-fat and low-carb diets both lost the same amount of weight after two years, according to a just-published article in Annals of Internal Medicine.  Both groups received intensive behavioral treatment, which may be the key to success for many.  Low-carb eating was clearly superior in terms of increased HDL cholesterol, which may help prevent heart disease and stroke.

The study was funded by the National Institutes of Health and was carried out in Denver, St. Louis, and Philadelphia.

How Was It Done?

Healthy adults aged 18-65 were randomly assigned to either a low-fat or low-carbohydrate diet.  Average age was 45.  Average body mass index was 36 (over 25 is overweight; over 30 is obese).  Of the 307 participants, two thirds were women.  People over 136 kg (299 lb) were excluded from the study—I guess because weight-loss through dieting is rarely successful at higher weights.  Diabetics were excluded. 

The low-carb diet:  Essentially the Atkins diet with a prolonged induction phase (12 weeks instead of two).  Started with maximum of 20 g carbs daily, as low-carb vegetables.  Increase carbs by 5 g per week thereafter as long as weight loss progressed as planned.  Fat and protein consumption were unlimited.  The primary behavioral goal was to limit carb consumption.

The low-fat diet:  Calories were limited to 1200-1500 /day (women) or 1500-1800 (men).  [Those levels in general are too low, in my opinion.]  Diet was to consist of about 55% of calories from carbs, 30% from fat, 15% from protein.  The primary behavioral goal was to limit overall energy (calorie) intake. 

Both groups received frequent, intensive in-person group therapy—lead by dietitians and psychologists—periodically over two years, covering such topics as self-monitoring, weight-loss tips, management of weight regain and noncompliance with assigned diet.  Regular walking was recommended.

Body composition was measured periodically with dual X-ray absorptiometry.

What Did They Find?

Both groups lost about 11% of initial body weight, but tended to regain so that after two years, both groups average losses were only 7% of initial weight.  Weight loss looked a little better at three months in the low-carb group, but it wasn’t statistically significant. 

The groups had no differences in bone density or body composition.

No serious cardiovascular illnesses were reported by participants.  During the first six months, the low-carb group reported more bad breath, hair loss, dry mouth, and constipation.  After six months, constipation in the low-carb group was the only symptom difference between the groups.

During the first six months, the low-fat group had greater decreases in LDL cholesterol (with potentially less risk of heart disease), but the difference did not persist for one or two years.

Increases in HDL cholesterol (potentially heart-healthy) persisted throughout the study for the low-carb group.  The increase was 20% above baseline.

About a third of participants in both groups dropped out of the study before the two years were up.  [Not unusual.]

My Comments

Contrary to several previous studies that suggested low-carb diets are more successful than low-fat, the study at hand indicates they are equivalent as long as dieters get intensive long-term group behavioral intervention. 

Low-carb critics warn that the diet will cause osteoporosis, a dangerous thinning of the bones that predisposes to fractures.  This study disproves that.

Contrary to widespread criticism that low-carb eating—with lots of fat and cholestrol— is bad for your heart, this study notes a sustained elevation in HDL cholesterol (“good cholesterol”) on the low-carb diet over two years.  This also suggests the low-carbers  followed the diet fairly well.  The investigators also note that low-carb eating tends to produce light, fluffy LDL cholesterol, which is felt to be less injurious to arteries compared to small, dense LDL cholesterol.

A major strength of the study is that it lasted two years, which is rare for weight-loss diet research.

A major weakness is that the investigators apparently didn’t do anything to document the participants’ degree of compliance with the assigned diet.  It’s well known that many people in this setting can follow a diet pretty well for two to four months.  After that, adherence typically drops off as people go back to their old habits.  The group therapy sessions probably improved compliance, but we don’t know since it wasn’t documented. 

How often do we hear “Diets don’t work.”  Well, that’s just wrong.

Overall, it’s an impressive study, and done well. 

Individuals wishing to lose weight on their own can’t replicate these study conditions because of the in-person behavioral intervention component.  There are lots of self-help calorie-restricted balanced diets (e.g., Sonoma Diet, The Zone,  Advanced Mediterranean Diet) and low-carb diets (e.g., Atkins Diet, Banting’s Letter on Corpulence, Low-Carb Mediterranean or Ketogenic Mediterranean Diets).  On-line support groups—e.g. Low Carb Friends and SparkPeople and 3 Fat Chicks on a Diet—could supply some necessary behavioral intervention strategies and support.  

Choosing a weight-loss program is not as easy as many think.  [Well, I’ll admit that choosing the wrong one is easy.]  I review the pertinent issues in my “Prepare for Weight Loss” page.

Steve Parker, M.D.

Reference: Foster, Gary, et al.  Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Annals of Internal Medicine, 153 (2010): 147-157   PMID: 20679559

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Drew Carey Succeeds With Very Low-Carb Diet

Jimmy Moore today at Livin’ La Vida Low Carb reports on Drew Carey’s fantastic success in losing 80 pounds (36.4 kg) of fat and controlling (curing?) his type 2 diabetes.  Jimmy says many Hollywood celebrities control their weight with carbohydrate-restricted eating.

Steve Parker, M.D.

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Basic Science: Mediterranean Diet Boosts Antioxidant Power

Compared to the low-fat American Heart Association diet, the traditional Mediterranean diet rich in olive oil has more capacity to counteract potentially harmful “free radicals” and “reactive oxygen species” in our bodies, according to researchers at the University of Navarra in Spain.

Our tissues normally contain free radicals and reactive oxygen species, which are intrinsic to cell metabolism.  They serve useful purposes.  In excessive amounts, however, many believe they cause “oxidative damage” and thereby contribute to chronic degenerative conditions such as atherosclerosis, aging, dementia, and cancer.

Antioxidants are thought to neutralize free radicals and reactive oxygen species, which may lead to better health.

The PREDIMED study is an ongoing Spanish project testing the heart-protective effects of the Mediterranean diet in high-risk people over the course of four years.  The three intervention groups are 1) Medi diet plus supplemental virgin olive oil, 2) Medi diet plus extra tree nuts, and 3) low-fat American Heart Association diet.

After three years of follow-up, the researchers measured “total antioxidant capacity” in the bloodstream of a subset of the PREDIMED participants.

They found that the two Mediterranean diet groups had significantly greater total antioxidant capacity, about 50% more than the low-fat control group.  Within the Medi + olive oil group, the participants with the highest levels of antioxidant capacity actually tended to lose weight, an association not seen in the other groups.

The Researchers’ Conclusions

Mediterranean diet, especially rich in virgin olive oil, is associatied with higher levels of plasma antioxidant capactiy.  Plasma total antioxidant capacity is related to a reduction in body weight after three years of intervention in a high cardiovascular risk population with a Mediterranean-style diet rich in virgin olive oil.

In other words, the Mediterranean diet with virgin olive oil may help you keep your weight under control, and the antioxidant capacity may contribute to the well-documented health benefits of the diet.

Steve Parker, M.D.

PS:  It’s impossible to tell from this report just how much weight loss was seen in the high-TAC Medi+olive oil subjects.  I doubt it was much.  Baseline body mass index for all participants was around 29, so they were overweight and just a shade under obese.

PPS:  Both the Ketogenic Mediterranean and Diabetic Mediterranean Diets mandate minimal amounts of olive oil consumption, with no upper limit.

Reference: Razquin, C., et al. A 3 year follow-up of a Mediterranean diet rich in virgin olive oil is associated with high plasma antioxidant capacity and reduced body weight gain.  European Journal of Clinical Nutrition, 63 (2009): 1,387-1,393.  doi 10.1038/ejcn.2009.106

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Nutritional Analysis of William Banting’s 1865 Diet

I recently blogged about London’s low-carb diet fad of 1865, originated by William Banting.  He’s often credited with popularizing the first “modern” low-carb diet.  Gary Taubes wrote about it in his Good Calories, Bad Calories book.  A participant at Active Low-Carber Forums took the time to analyze Banting’s diet.

At 100 g of carbs, Banting’s diet had about a third as much as today’s usual U.S. diet.

From elisaannh at Active Low-Carber Forums:

I entered Banting’s diet into my nutritional software and it came up to 1925 calories, 101gr carbs, 8gr fiber and 128gr protein, 34gr fat. I used 5.5 oz when he said 5-6 oz, and did add 3 oz brandy for his “tumbler” of grog which he said “if required”. The total oz for his wine and brandy is quite high, at 20! YUM!

I think the diet is a definite improvement over the diet in England at that time period. However, cooked fruit and bread are not necessary, and he doesn’t mention added fat, which I feel his diet is too low in. Perhaps the meat was well marbled, but I did use fish in the calc for his supper at 2 pm (beef and chicken were the other two meats I used to balance it out in the other meals). Prunes were used for the “cooked fruit from a pudding” and apples for his tea time fruit. Green beans were used for his vegetable.

[Reprinted with elisaannh’s permission.]

For screen shots of the calculations: http://picasaweb.google.com/elisaan…feat=directlink

Elisaannh also has a diet blog at http://thelittlebowl.blogspot.com.  Many thanks to Elisaannh, who is a long-haul trucker.

Steve Parker, M.D.

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The Holy Grail: Prevention of Weight Regain

Losing excess weight is easier than keeping it off.

Neither is exactly a walk in the park.

Prevention of weight regain is the most problematic area in the field of weight management.  You may have heard that “diets don’t work,” but they do.  Many different weight loss programs work short-term, if “work” is defined as loss of five, 10, or more pounds while you adhere to the program for several weeks or months.  The problem is that the lost pounds usually return.

Why?  You get bored with the diet, or your willpower flags, or the diet simply stops working, or the transition from weight loss to maintenance is unclear, or you just feel too bad to go on, or you lose your commitment, or you take a job as a taste tester for Baskin-Robbins Ice Cream, or whatever. 

Most diets ultimately fail in the long run because people go back to their old habits. 

Read on for the secret to prevention of weight regain.  They apply to a majority of weight-loss methods, although many programs ignore this problem because the cure is a hard pill to swallow. 

Moving Ahead

For purposes of further discussion, I will assume that you have already lost excess weight down to your goal and now we must focus on staying thereabouts from here on out.  Finally down to your goal!  A grand accomplishment!  You’ve got a new wardrobe, or the old clothes fit again.  You have more energy and feel younger.  Maybe you cured or improved some health problems.  Perhaps you’re getting more attention from the opposite sex (ooh la la!). 

Our species’ scientific name is Homo sapiens.  It is from the Latin sapere, which means “to be wise.”  Wisdom is the ability to make correct judgments and decisions.  Undoubtedly, your success at weight loss required correct judgments and decisions.  You are not done yet.  You will need sustained wisdom to avoid weight regain.

Be wise about this especially: you can never again eat all you want, whenever you want, over sustained periods of time.  

Now that you have reached your goal weight, you must restrain yourself on a daily basis.  Think about it.  You became overweight because you didn’t watch what you ate and didn’t exercise enough.  You can’t go back to your old ways.  Reject this advice, and you have a 100 percent chance of regaining your lost weight. 

Have you heard of the Energy Balance Equation?

Calorie Intake minus Calories Burned

         =  Change in Body Fat

You have been able to lose fat weight because you ate less energy (calories) than your body required for metabolism and physical activity.  Your body remedied the energy deficit by converting fat into energy.  A pound of fat contains 3,500 calories of energy.  If you lost a pound per week, your body on average converted 500 calories of fat daily into energy (7 days x 500 calories = 3,500 calories = 1 pound of fat). 

Now that you are at your goal weight and want to stay there, you need to add 500 calories per day back into the equation.  Add the calories by eating more food, exercising less, or a combination of the two. But if you add back more than 500, you will regain weight.

The true measure of a successful weight management program is not simply how much weight is lost, but whether the lost weight stays lost over the long run.  What distinguishes weight losers who keep the weight off from those who gain it back?  Two factors, mostly:

          1.  Restrained eating
          2.  Regular physical activity
.

“Successful losers” apply self-restraint on an almost daily basis, avoiding food that they know will lead to weight regain.  They limit how much they eat.  They consciously choose not to return to their old eating habits, despite urges to the contrary.  The other glaring difference is that, compared to regainers, the successful losers remain physically active.  They exercised while losing weight, and continue to exercise in the maintenance phase of their program.  This is true in at least eight out of 10 cases.  It’s clear that regular exercise is not always needed, but it dramatically increases your chances of long-term success. 

In a nutshell, my maintenance phase prescription for you is: Keep exercising, and eat a little more.  Keep exercising, and eat a little more.

Go out of your way to be physically active for 30 to 45 minutes on at least four days per week, if not all days.  Walking is fine.  The more you exercise, the more you can eat without getting fat again. 

At the end of your weight-loss phase and the beginning of the maintenance phase, it is surprisingly easy to start overeating.  Forewarned is forearmed.  Avoid this landmine any way you can.  It helps to continue monitoring food consumption and exercise on your food diary while eating an additional 200–500 calories per day.  Continue weighing daily.  Keep exercising.  After a month or two of this regimen, you’ll have an intuitive sense of what and how much you should be eating without regaining weight.  Then stop the daily log routine. 

Another option for transition to the maintenance phase: if you have been exercising regularly but loathe it, you could stop exercising and stay on your current calorie level diet.  In other words, don’t start eating more.  See what happens with your weight.  Perhaps you could later eat an extra 100 to 200 daily calories without gaining weight.  Continue recording your daily intake and weight for a couple months.  

Weigh yourself daily during the first two months of your maintenance-of-weight-loss phase. After that, weigh weekly.  Daily weights will remind you how hard you worked to achieve your goal.  When you look now at a brownie, candy bar, or piece of pie, you ask yourself, “Do I really want to walk an extra hour or jog an extra three miles today to burn off those calories?” If so, enjoy. Otherwise, forego the unneeded calories. 

Be aware that you might regain five or 10 pounds of fat now and then.  You probably will.  It’s not the end of the world.  It’s human nature.  You’re not a failure; you’re human.  

But draw the line and get back on your old weight-loss program for one or two months.  Analyze and learn from the episode.  Why did it happen?  Slipping back into your old ways? Slacking off on exercise?  Too many special occasion feasts?  Allowing junk food back into the house?  Learn which food item is your nemesis—the food that consistently torpedoes your resolve to eat right.  For example, I have two—candy, and sweet baked goods such as cookies and muffins.  If I just look at them I add a pound.  Remember an old ad campaign for a potato chip: “Betcha can’t eat just one!”?  Well, I can’t eat just one cookie.  So I don’t get started.  I might eat one if it’s the last one available.  Or I satisfy my sweet craving with fresh fruit or a diet soda.  Just as a recovering alcoholic can’t drink any alcohol, perhaps you should totally abstain from…?  You know your own personal gastronomic Achilles heel.  Or heels.  Experiment with various strategies for vanquishing your nemesis. 

It’s OK to overindulge in food infrequently (10–12 times per year), on special occasions such as birthdays, wedding anniversaries, holidays.  But you must counteract the extra calories by cutting down intake or by exercising more, either before or after the feast.  No big deal.

Click to read additional ideas on prevention of weight regain.

Steve Parker, M.D.

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