The $12M NuSI/Ludwig Study ~ Part IV: Insulin Resistance Does Not Hamper Weight Loss

      

Continuing on with discussion of:

Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial

No summary for this post.  Here are links to earlier parts in this series:

Part I: Critique of the Study Design

Part II: $12 Million for 12% Weight Loss?

Part III: Some "Early" Lessons:  In this most recent post, I discussed the relationship between measures of insulin (both fasting and 30 minute OGTT response) and weight loss during the Run-In Phase.  

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

SUMMARY

Continuing on with discussion of:

Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial

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

In Part II, I highlighted a serious issue with the Run-In Phase, the purpose of which was to produce a somewhat homogeneous "reduced weight state" to test various diets in maintenance of that state.

Ultimately, since randomization to the various test diets occurred after weight loss (PWL) randomization to maintenance test diet would not influence the impact 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 so as to produce a more uniform result.  Rather, the result was a wide range of weight loss (5.6 to 16.0%, roughly 10.5% ± 5%) . 

Thus we have an "accidental" test-within-a-test of the CIH/TWICHOO from these "early" results.

In the end, I offer these scatter plots for all 105 subjects who successfully completed the study, for whom complete data for insulin measures and energy expenditure 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 lesser the weight loss.  The Run-In Phase data supports no such relationship (indeed, if anything, absolute weight loss was greater for those with higher baseline insulin measures.

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

This post expands on some relationships of baseline (BSL) and post-weight loss (PWL) measures as observed during the weight loss portion of the Run-In Phase.

Bottom Line:  Baseline insulin status seems to be irrelevant to weight loss on a "high carb" calorie-restricted diet.  

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The $12M NuSI/ Ludwig Study ~ Part II: $12 Million for 12% Weight Loss?

SUMMARY

This post focuses on a critical issue with the Run-In phase of the recently released $12 million dollar NuSI funded study led by David S. Ludwig MD, PhD: Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. On occasion I reference the 2012 predecessor: Effects of Dietary Composition on Energy Expenditure During Weight-Loss Maintenance.

Virtually every stipulation leading up to the study, the Abstract and Full Text of the journal article, and continuing through to Ludwig's November 28, 2018 response to Kevin Hall in BMJ,  has stated that the MAIN purpose of the Run-In phase was to achieve 12%  ± 2% weight loss.  The study was intended to test the so-called Carb-Insulin Hypothesis during 20 weeks of weight-stable maintenance on diets of varying carbohydrate content.


OUTCOME:

With only 10 weeks of 60% calorie restriction during Run-In, the subjects who completed this phase averaged 10.5% weight loss (std.dev. 1.7%), ranging from only 5.6% up to 16.7% weight loss.  This doesn't change much for analyses of just those completers for whom complete energy data are available (same mean, SD = 1.5%, range 5.9% to 16.0%).

This indicates an unacceptable variation in the post-weight loss (PWL) "biological state", and to use this as the baseline "anchor" for diet comparisons is negated by either Study Design and/or execution thereof.

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The $12M NuSI/Ludwig Study: Part I: Critique of the Study Design

SUMMARY

The results of the $12 Million Dollar NuSI-sponsored study, headed up by Dr. David S. Ludwig, are finally out.  

Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial

While the good doctor is making the rounds touting them as evidence in support of the Carb-Insulin Hypothesis (TWICHOO in these parts), a review of the raw data made available to the public casts grave doubts on his victory lap.  This study built upon the "promising" results of the 2012 study:  

Effects of Dietary Composition on Energy Expenditure During Weight-Loss Maintenance  

This post focuses on comparisons of Study Design between these two studies, some improvements, and the ultimate failure that renders the primary outcome data suspect, if not outright useless.  (And I don't say that lightly!)

Improvements:

• Study size
• Length of time on one test diet (20 weeks) vs. 4 weeks crossover on each diet w/o washout
• Protein held constant between test diets
• Macro extremes the same -- e.g. LCHF = 20% carb/60% fat , HCLF = 60% carb / 20% fat
• Post weight loss (PWL) assessment of TEE
• Intake adjusted to maintain weight

Detrimental Changes:

• Drastically altered run-in phase 
• Shorter in total:  16 weeks vs. 20 weeks
• No monitoring period before gathering baseline data.
• No baseline intake assessment
• Shorter weight loss phase:  10 weeks vs. 12 weeks
• More varied weight loss and no minimum loss established to be included in the test phase.  In previous study, all subjects had to achieve at least 10% loss, averaged 13.5%.  Current study, losses ranged from 5.6% to 16.0%
• Only 2 weeks for weight stabilization vs. 4 weeks.
• Added ad libitum snacks for those who needed to increase caloric intake in maintenance but could not tolerate the larger meals necessary.
• Assessing post weight loss DLW-TEE during the same two weeks immediately following weight loss that are designated for stabilizing reduced weight.
• Changing protocol to anchor TEE changes to this flawed PWL measure of TEE instead of baseline per original protocol.

Why Aren't We Taking Anti-Obesity Drugs?

This post was prompted by the following article on Medscape

Why Aren't We Prescribing Pills for Obesity?

It is written by Caroline M. Apovian, MD 

I'd encourage you to read this whole thing first, as I'm genuinely interested in that response. Additionally I'm curious as to whether or not your response changes after reading this blog post (or other sources I'm about to link to).

"Real Food Keto" Quips

Rather than formally reviewing Real Food Keto -- an abomination of a book written by Jimmy Moore and his "Nutritional Therapy Practitioner" wife Christine Moore -- I've decided to compile a collection of my tweets here in a blog post.  I'll sort from most recent, with the newest before the "page break" after each update.  Feel free to comment here, but I'm also embedding tweets if you wish to go respond on Twitter.   Some may include additional commentary, others just the tweet. Enjoy!

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This book is littered with nonsense about how low stomach acid causes everything from ass itching  to zygomycosis.   No doubt there will be more of these tweets coming!

Fun #RealFoodKeto "facts" from @livinlowcarbman and his NTP wife.

FACT: Lemon juice (mostly citric acid) gives it a pH ~2.  Add some to neutral water (pH 7), the lemon water will be less acidic (e.g. higher pH, closer to 7) but will not become alkaline (pH >7)#LCHF-raud pic.twitter.com/QX7gJ1x6qS

— Evelyn (@CarbSane) October 31, 2018

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Swan Song

[no I'm not retiring the blog]

TLDR:  Rather than dragging things on by dismissing more black swans, Gary Taubes could eat crow and go quietly into the night.

After a long hiatus from any meaningful new content, and monumental blows to TWICHOO (Taubes Wrong Insulin Carbohydrate Hypothesis Of Obesity -- c'mon, it has a much better ring to it than the Ludwigian version),, Gary Taubes has gotten back to blogging a bit.*

He has apparently been reading (in fits and starts, in other words, probably not really reading) obscure books about obscure cultures from long, long ago.  Mind you, that in five years plus of arduous and comprehensive research put forth in Good Calories, Bad Calories, there was no mention of the Yahgan people he's about to discuss.   One wonders why not.  Heck, this is right in his time period of excellence for nutritional research and reporting!  (Uttermost Parts of the Earth, this is to a 2007 version of a book Taubes states was published in 1948).  But alas, no Yahgan (I also checked Wikipedia's alternate spellings), among the conventional-wisdom-challenging by Taubes circa 2007.

It's OK really, nobody expects you to track down every obscure culture, especially one that counters your hypotheses.  Shhh... look away ... no paradoxes to be found here!

Fast forward to 2018.  Currently, Gary Taubes has been  thinking about black swans as he engages in a bit of light Summer reading.  Perhaps no longer needing to devote so much time to NuSI has opened up a lot of free time for such endeavors.

(*something I still hold out hope of doing more of myself)

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Where did the fat in this blood come from? ~ An Ead-iotic Analysis

NOTE  (8/7/2018):    So I've edited this post, originally written/published 5/5/2011, to omit the no longer relevant back story and defunct links.  I refer to a discussion on Jimmy Moore's now-long-defunct LLVLC Discussion Board that made me aware of the Eades' post discussed.

I'm bumping this for reasons that should become obvious soon.

SUMMARY:  Fat in the blood following a fatty meal is almost entirely due to the fat in the meal. 

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Several years ago, Dr. Michael Eades wrote the following post:  ABC’s big meal propaganda.  Sadly, the video is no longer available.  It involved subjects consuming a GIGANTIC meal of 6000 calories, after which blood was drawn two hours later.  This "after" blood was very cloudy, and the technician holds this up and identifies the source of the cloudiness as fat.  The meal was deep fat fried mac&cheese, a bacon cheese burger quesadilla and fries and an ice cream smothered giant cookie.  Yes, high in fat and carbs, but favoring the starches.  While they pointed finger at just the saturated fat -- it was 187g of saturated fat == it's not too much of a stretch to estimate this meal contained around 300-350g total fat or more.

Quotable Quotes: Taubes the Radical!

Due to a recent article in Wired, I think this (6/30/14) post could use a hearty bump.  These words were uttered just over a decade ago by Gary Taubes. 

THE COLLAPSE OF A $40 MILLION NUTRITION SCIENCE CRUSADE

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Seth Roberts:  But you'd seen Nobel-Prize-winning physicists get it very wrong.

Gary Taubes:  But what they were getting wrong were subtle; yes, they'd believe incorrectly that they'd discovered elementary particles, but what they were doing was a real subtle game. What they were misinterpreting were extraordinarily subtle aspects of the data.  

This obesity screw-up is fundamental; it’s like a grade school error in the interpretation of the laws of thermodynamics.  

And I made it as well, up until five years ago. I never thought differently. 

But what radicalized me is that they don't care.  If they successfully ward off my threat to their beliefs, then I'm in a very dangerous place.  Then it's, like I said, where I end up a bitter demented old man, one of those guys who's muttering to himself all the time that they, the establishment, didn't listen to him…

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I don't mean to wish ill on a person, but if he doesn't end up a muttering demented old man, it means that fantasy wins out over fact, and sensationalism over science.  

Thoughts on Obesity as "Disease" or Choice ~ Part 1: Smoking & Lung Cancer Analogy

Recently (May 2018) comments about obesity at a Pediatric conference have made the rounds. Specifically: Obesity Is a Disease, Not a Choice, Experts Advise.  Here is link to the full text in  "print version".

The AMA classified Obesity as a disease in 2013. Five years later we've made little to no progress, likely because we've got "experts" pontificating and arguing over semantics and false dichotomies.  The false dichotomy of Disease vs. Choice is right out of whatever master playbook teaches that if you keep the "masses" arguing, they might not notice you're full of it.  It's really the only explanation I can think of for the circular arguments made with nary a tinge of irony on board straight faces.

I have a bunch of stuff in the draft pile here on this topic, but cannot seem to organize it. I decided to start a series.  In no particular order.  

This installment deals with the following statement from the 2013 Resolution by the AMA:

Whereas, Progress in the development of lifestyle modification therapy, pharmacotherapy, and bariatric surgery options has now enabled a more robust medical model for the management of obesity as a chronic disease utilizing data-driven evidenced-based algorithms that optimize the benefit/risk ratio and patient outcomes; and

Whereas, The suggestion that obesity is not a disease but rather a consequence of a chosen lifestyle exemplified by overeating and/or inactivity is equivalent to suggesting that lung cancer is not a disease because it was brought about by individual choice to smoke cigarettes; and

Whereas, The Council on Science and Public Health has prepared a report that provides a thorough examination of the major factors that impact this issue, the Council’s report would  receive much more of the recognition and dissemination it deserves by identifying the enormous humanitarian and economic impact of obesity as requiring the medical care, research and education attention of other major global medical diseases; therefore be it