It’s the Calories, Stupid!

In determining clinical effectiveness, a randomized controlled trial involving an adequate number of volunteers is required by most experts.  A short time ago, however, there was a push from some areas for an ‘N of one’ trial, meaning that a single patient might be enough.  The important feature in such a trial is that the order and duration of the ‘active treatment’ is randomized, so this term cannot be applied to the much-publicized story of Professor Mark Haub and his ‘Twinkie diet’ experience.  But his experience does provide us with an important reminder: calories in minus calories out = weight change.

Professor Haub lost 27 pounds in 10 weeks by following a restricted calorie diet – 1,800 calories/day – whereas his ‘requirement’ was about 2,600 calories/day.  His diet consisted of junk food, a protein shake, multivitamin pills and a can of green beans or 4 celery stalks daily.  Sounds fairly easy, doesn’t it?  But he watched the total calorie intake vigilantly.       

Haub wanted to find out whether tasty-but-trashy food – Twinkies, Doritos, Orios, or other foods high in sugar and saturated fats – would influence his efforts

to lose weight.  So he watched the calories but ignored most of the actual food content.  However, he took a protein shake daily, as well as a can of green beans or 4 stalks of celery.

His changes over the 10 week period can be summarized:

His weight went from 210 pounds to 174 pounds;  His BMI went from 28.8 to 17.4;  his LDL went from 153 to 123 mEq/L;  his HDL went from 37 to 46 mEq/L;  and his triglycerides fell 39%.   (All this in spite of the Twinkies, Orios, etc!)

Of course, he was hungry – a lot.  And who knows if he could have kept this up longer than 10 weeks.  But still, he proved that “calories in minus calories out = weight change”, which is really all he set out to do, and which could be a leitmotiv for many of us.  Maybe an “N of one” study has it’s uses, even if it’s not randomized!