The $12M NuSI/Ludwig Study ~ Part III: Some "Early" Lessons

In Part I, I discussed some issues with methodology, mostly focusing on the decreased Run-In Phase that probably compromised the outcomes irreparably.

In Part II, I highlighted a critical issue with the Run-In Stage, the purpose of which was to produce a somewhat homogeneous”reduced weight condition” to test various diets in maintenance of the state.

Finally, since randomization to the a variety of test diets occurred after weight loss (PWL) randomization to maintenance evaluation diet wouldn’t influence the effects of various BSL (pre-weight loss baseline) measures on the Run-In outcome — target = 12% ± 2% weight loss — on a standard composition diet for all:  45% Carb / 30% Fat / 25% Protein.

The researchers appear to have made minimal adjustments, if any, during the Run-In Weight Loss in order to produce a result that is uniform.  Rather, the result was a wide range of weight loss (5.6 to 16.0%, roughly 10.5% ± 5 percent ). 

Thus we’ve got an”accidental” test-within-a-test of this CIH/TWICHOO from these”early” results.

In the long run, I provide these scatter plots for all 105 subjects who successfully completed the analysis, for whom complete data for energy expenditure and insulin measures were available at all time points.

The Carb-Insulin Hypothesis (aka TWICHOO) predicts that weight loss will vary inversely with insulin levels:  The higher the insulin levels, the lower the weight loss.  The Run-In Stage data supports no such connection (indeed, if anything, complete weight loss was higher for those with higher baseline insulin steps.

Meanwhile, differences in weight loss can easily be explained by variation in caloric deficit throughout the calorie restricted Run-In due to rough estimation of baseline energy expenditure (vs. rigorous measure).

This post expands on some relationships of baseline (BSL) and post-weight loss (PWL) steps as detected during the weight loss part of this Run-In Phase.