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ND DiRECT updates

Discussion in 'Low Calorie Diets' started by bulkbiker, Dec 2, 2018.

  1. kokhongw

    kokhongw I reversed my Type 2 · Well-Known Member

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  2. Goonergal

    Goonergal Type 2 · Moderator
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    Wow! I know which site has helped me.
     
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  3. bulkbiker

    bulkbiker Type 2 · Oracle

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    I have since discovered that dietary adherence was measured by the ketone levels of the participants.. they had to be in nutritional ketosis...So did ND work because the participants were in ketosis rather than because they were being starved.. hmm
     
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  4. kokhongw

    kokhongw I reversed my Type 2 · Well-Known Member

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    But it is an important point that is not highlighted any where in Dr Taylor's presentation...that achieving/maintaining ketosis is the goal...and VLCD is simply one of the many available paths...

    https://www.ncl.ac.uk/magres/research/diabetes/reversal/#publicinformation

    That greatly diminished my views of the Newcastle's efforts...
     
  5. Rachox

    Rachox Type 2 (in remission!) · Moderator
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    I dread to think where I’d be now if I hadn’t found this forum.
    Surely the statement above is libellous?
     
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  6. Oldvatr

    Oldvatr Type 2 · Expert

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    Thr Optifast shake manufacturer supplying the original studies also says that dietary ketosis may occur in some cases, but is not always present, They warn it MAY happen, but it is intended to be just above the trigger level for most followers of their 800 plan. I suspect the DIRECT plan is similar but they have set up their own production line to make more money out of DUK and the NHS in the longer term.
     
  7. kokhongw

    kokhongw I reversed my Type 2 · Well-Known Member

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    Sadly it is all beginning to look and sound like a rehashed marketing efforts for VLCD diet suppliers...and explains why there's generous funding for the effort...vs low carb, keto, IF etc...which can all achieve and sustain ketosis rather easily...
     
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  8. Oldvatr

    Oldvatr Type 2 · Expert

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    How did you get this info since it is not mentioned in any formal report I have seen, and has also not been mentioned by those here who took part in some of the trials. I think that if they are indeed using ketosis intentionally, then this would kill their support from the NHS, nutritionists, doctors, and everyone providing care for diabetics, in the same way that LC diets get pilloried. They cannot afford to admit any link to ketosis,

    The testing for ketosis on a regular basis is an expense that they did not need to control their protocol, and c-peptide tests or insulin clamp tests would be prohibitive for large scale rollout, and again it was not necessary for their protocol. Don't forget that originslly the aim was simply to mimic bariatric surgery to find a cheaper non invasive alternative for further research. They needed to show that diabetes symptoms are reduced by the protocol, but they were surprised at the success they had, Now DIRECT is the first chance they have of really getting to grips with it, but it seems that they are still just looking for the bariatric replacement, and a way to mass produce the protocol, hence setting up their own company to run it. They've sold out to commercial interests IMO
     
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  9. bulkbiker

    bulkbiker Type 2 · Oracle

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    It was pointed out to me on twitter yesterday by Jan Vyjidak from this paper

    https://link.springer.com/article/10.1007/s00125-011-2204-7

    "Dietary adherence was assessed using capillary ketone levels (Xceed Optium; Abbott Diabetes Care, Maidenhead, UK). Three individuals failed to comply with the diet (two during the first week and one during weeks 4–8), and one left the study for an unrelated medical reason. Hence 11 individuals (nine male and two female, age 49.5 ± 2.5 years) completed the study."

    This is the first trial for the ND experiment Counterpoint I think it is.. I get very confused with the naming ..
     
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  10. Oldvatr

    Oldvatr Type 2 · Expert

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    Agree. This first study was small scale and did indeed do a load of tests that I do not thinke were used in subsequent trials. They did full c-peptide tests, insulin clamps tests, OGTT, hepatic glucose with intravenous measurements of plasma blood levels etc. But only on 11 subjects (we do not know which group the dropouts occurred in) It looks like these tests were done in weeks 1,2, and 8 but not sure if this was the frequency for the ketone measurements too, since they could occur more frequently being less invasive. They also did the MRI scans in this trial.

    Again, unlikely to have this level of scrutiny in a larger study population,

    But it does seem that ketosis was intended and checked in this initial study. Interesting that the control group were not given these tests except at week 8. In fact there is very little said about the control group. I have always suspected that even a borderline VLCD close to trigger will give periods of ketosis during the activities of a normal day, so is similar to IF in this respect. Its just that they cannot admit it.

    The conclusion does not involve the control group, except to say:
    "Although pancreatic fat content was 30% higher in the diabetic group, the study was powered to demonstrate responses to the dietary intervention rather than to test differences from weight-matched non-diabetic individuals. No correlation was observed between pancreatic fat and BMI within the restricted range of BMI examined in this study."

    One interesting point I picked up on this re-visit, and that was the comments that the IR response improvement was independant of changes to the peripheral IR in the muscles, but was solely due to hepatic fat reduction. Also noted the comment that bariatric banding does not produce remission, but the bypass surgery does.
     
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    #30 Oldvatr, Dec 3, 2018 at 10:48 AM
    Last edited: Dec 3, 2018
  11. bulkbiker

    bulkbiker Type 2 · Oracle

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    I wonder if the tests were indeed done in the later trials.. (to ensure compliance) but conveniently not noted in the write ups.. the more I read about this stuff the more my view that something very dodgy is going on with the Low Cal trials is reinforced.
     
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  12. kokhongw

    kokhongw I reversed my Type 2 · Well-Known Member

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    From what I can see, there's little question that much delibrate effort was applied to obscure the role of ketosis in the Newcastle protocol. Surprise that the peer review don't bring up this aspect at all...what is the ketosis criteria they use to determine compliance.
     
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  13. bulkbiker

    bulkbiker Type 2 · Oracle

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    Im guessing it was any at all... with 60g of carbs per day in the shakes I'm surprised they maintained ketosis at all..obviously starvation helped...
     
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  14. bulkbiker

    bulkbiker Type 2 · Oracle

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    I need to sit down and read all the new info on DiRECT.. sorry but just haven't had time yet..
     
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  15. Oldvatr

    Oldvatr Type 2 · Expert

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    I think you will find that it breaks no new wind. It is a re-run of the previous study but just using the weight loss program with minimal supervision and no significant changes to the protocol, It seems to be merely a trial to check that it can be applied to Primary care setting with minimum training (8 hours) and low resources. It uses the annual diabetic checkup as the 1 and 2 year followups, which is ok for a public rollout,

    I do not think it reveals any breakthroughs, the results are similar to the previous study but using NHS facilites and staff.

    There was no body composition measurements apart from BMI. There seemed to be higher dropout on this study and more secondary interventions both for weight loss and for meds. No keto measurements from the look of it or mention of it. The carb content seems to be higher in this trial, but the reintroduce foods carbs drops down after the diet ends.

    Weight seems to increase gradually during the reintroduction phase, but jumps suddenly in those that dropped out so yes it does seem that going back to the old ways will quickly negate any effect from the diet, as one would expect.

    We are at Year 1 review time so remains to be seen how long the effect can be maintained. Again only approx 50% success at Year 1, and not everyone achieved the weight target. The control group also had some success of its own, withour intervention but not to any great degree.
     
  16. bulkbiker

    bulkbiker Type 2 · Oracle

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    Agree but they give a huge amount more detail of what the follow up post the 8 week starve is..
    I think and fear it may end up being 1200 cals per day for life.. which considering the Minnesota Starvation Experiment was based on I believe 1570 cals ? then it's a pretty miserable way to try and live and doomed to failure from the start?
    But I do need to read it in depth first..
     
  17. Oldvatr

    Oldvatr Type 2 · Expert

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    It is here
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4754868/
    The maintenance phase is basically Eatwell with emphasis on reduced fat, There is built into this phase recovey plans to return to the shakes for a while or use Orlistat for heavy duty weight loss, Guess what? revolving door syndrome lives here. Got the T-shirt too.

    Edit to add: There seems to be a subgroup that will undergo extra tests and monitoring, This seems to involve MRI scans and insulin clamp testing amongst others, so it would appear that this is part of the follow up yet to come and is the science bit.
     
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    #37 Oldvatr, Dec 3, 2018 at 4:04 PM
    Last edited: Dec 3, 2018
  18. bulkbiker

    bulkbiker Type 2 · Oracle

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    Some mildly interesting numbers here
    https://www.directclinicaltrial.org.uk/Pubfiles/DiRECT1yrPaperSupplementaryAppendix.pdf
     
  19. AloeSvea

    AloeSvea Type 2 · Well-Known Member

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    Do the Newcastle Uni folks really believe deliberately eating less than satiation, as in 1200 cals per day, is do-able for life? Good grief.

    I am hoping you expect an emotional but direct comment from me? Here it is - isn't that a form of torture? (Yes, I agree with @bulkbiker bringing up Dr Mengele's, I mean Ancel Key's Minnesota starvation experiment here.)

    Hunger has evolved, let us remind ourselves, to be very uncomfortable. Miserable. Unbearable. So we crawl out of caves, get a spurt of energy from those lovely ketones, and go and get ourselves something to eat!

    The only people I know who do that, outside of the diabetes-experiments, as in deliberately eat too little, who don't have an eating disorder, like - for life, have had bariatric surgery - no surprise there. They can eat way less than is comfortable for the rest of us human beings because they physically can't eat the usual amount. (And eating disorders are a whole other ball game.)

    Even people who 'eat like birds' (I think of Herr Svea and his family of origin here), can dig into a fair amount of energy providing food - it might be a little - but can pack an energetic punch! Thinking about nuts and cheese in particular. Or salsa chips!

    I stayed with a very dear old friend recently who has lived post bariatric surgery for about ten years now, and... what is a nice way to say it? Permanently mood disordered. That's the nicest way to say it (darling that my friend is.) And seeing his diet up close and personal - I would absolutely say he is malnourished, from eating too little, and of a basically 'frankenfood' diet to boot. It wasn't pretty.

    And, dare I say it - as a longtime Roseanne fan - mental health issues, mood disorders, and still getting plump/unhealthy body fat even with most of your stomach and intestines gone... well. I cannot see how this can be a good thing for we human beings. Putting it mildly. Even if prone to mental health issues beforehand, being permanently hungry and malnourished can't help!

    If I had the choice between being diabetic, or living permanently hungry, I would have to say - I would/choose the former! Because being permanently hungry is not just about hunger. It is also being able to socialise, mix with family, friends and workmates without trying to kill them (and possibly trying to eat them!) (The latter was a joke.) (Sort of.)
     
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  20. bulkbiker

    bulkbiker Type 2 · Oracle

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    The thing I found most interesting about the extra info is mainly found in table S4 in the Supplementary Appendix namely that of the 138 subjects in the ND arm only 40 (29%) managed to get what we would call into remission (HbA1c lower than 42mmol/l) . Of which 1 was still on oral meds after 1 year. Even more interesting is that 7 out of 148(4.7%) in the control arm (i.e. regular advice) managed to get there too including 1 on no meds whatsoever.. No-one has explained how that happened.. So if we were looking for an NHS revision of diagnosis to T2 in remission then the study only had 29% success rate. I wonder if that would have gone down so well if it had been better publicised... I wonder if we'll get this level of detail in the 2 year follow up....?
     
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