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Fda Comment Period Open For 20 Ppm Standard For Gluten Free


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27 replies to this topic

#16 dilettantesteph

 
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Posted 21 August 2011 - 10:59 AM

Here's what about.com has to say about it.
http://celiacdisease...sues-report.htm

It would certainly be a bad idea to make gluten free be a level that is unsafe. Could we super sensitives be the canaries in the coal mine?
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#17 T.H.

 
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Posted 23 August 2011 - 08:10 AM

It would certainly be a bad idea to make gluten free be a level that is unsafe. Could we super sensitives be the canaries in the coal mine?



Wouldn't surprise me. Although with more and more celiacs not healing after years on the diet, I would not be surprised if we're just the lucky ones who don't heal AND react noticeably enough that we can actually tell what to avoid.

How much more difficult would it be to react to low levels of gluten and NOT have a noticeable reaction?
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T.H.

Gluten free since August 10, 2009.
21 years with undiagnosed Celiac Disease

23 years with undiagnosed sulfite sensitivity

25 years with undiagnosed mast cell activation disorder (MCAD) 

 

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#18 RollingAlong

 
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Posted 23 August 2011 - 01:45 PM

My other concern with the safe threshold study is that it lasted for 90 days. Is that long enough?

http://www.ajcn.org/...t/85/1/160.long
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#19 Takala

 
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Posted 23 August 2011 - 09:51 PM

No, no, no, no, and NO on the "low gluten" category.

This is horrible, and this is the only thing we are going to get with the commercial, for - profit mindcast in DC, if they think that they can palm off a "low gluten" category on everyone.

I may not be a "super sensitive," but I am in complete sympathy with them, as I'm certainly not a "silent, latent, can't tell when it has gluten" type, either. I have also gotten sick off of many foods already supposedly labeled "gluten free," so I deduct from this that the current, voluntary standards are quite lax and imaginative as to what is gluten free or not.

Food manufacturers need the option of being able to say on their labels they have tested and their product is below 20 ppm.

Food manufacturers and importers absolutely must not be allowed to make or import food out of wheat, rye, or barley processed starch and be able to include this processed wheat starch in the food, and still call it gluten free. If wheat, rye, or barley is in a food, it needs to be noted on the label, such as contains: vinegar, source, corn and/or wheat.

While we are at it, it is also scandalous that the medicine and supplement makers, over the counter and prescription, don't have to call these out, either. Some of the OTC pharmaceutical products are doing it voluntarily, but there are so many grain fillers being used now it is mind boggling.
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#20 dilettantesteph

 
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Posted 24 August 2011 - 04:22 AM

My other concern with the safe threshold study is that it lasted for 90 days. Is that long enough?

http://www.ajcn.org/...t/85/1/160.long

In this study, the participants were ones who were healthy already eating a 20 ppm gluten limit diet. It isn't a surprise that most of these participants were found able to tolerate it.

Also, "One patient (challenged with 10 mg gluten) developed a clinical relapse."

They must have had one of us in the study, but he was eliminated because he got sick. I don't see how someone can be eliminated from a study with a very small number of participants, yet the conclusion was that these amounts of gluten are safe.
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#21 Takala

 
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Posted 24 August 2011 - 10:42 PM

They must have been throwing out the highs and lows (extremes) and going for the mean average. (Been decades since I had statistics, hope that made sense) but by using a small number of participants, if they would have expanded it to be a representational sample, it would have meant a large number of people would have been shown to be getting sick on the 10 ppm.

That would have looked bad. Hence "one of you" got chucked out, as you said.

Doesn't this drive one nuts thinking about it.

We all are the canaries in the coal mine, I've said this before, because there is no way of telling how many more people are going to be influenced by their environmental stresses (such as pollution or infections) to trigger into not tolerating gluten proteins in the world's most popular grain - currently.

Monsanto's Round Up is designed to kill pigweed - which is closely related to amaranth. Which the Native Americans cultivated. http://en.wikipedia....tritional_value

Yet their focus is now on adapting crops to the herbicides, instead of looking to grow crops that don't need it.
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#22 U Gluten Free

 
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Posted 26 August 2011 - 06:31 PM

And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:



I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.


Good point, T.H.
While the patient who dropped out of the trial may indeed be clinically significant , it is usual for a trial design to be fixed at the start, so that only data from patients who complete all the steps of a trial can be included in the final data.
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#23 RollingAlong

 
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Posted 27 August 2011 - 05:32 AM

As best I can tell, even a 5ppm standard won't help the super sensitives, but I am very concerned that their existence be acknowledged and accomodated in institutional settings, even if they can not participate in the modern, processed food system.

My other concern is, I've been calling them the "miniscule minority," but I wonder if the group is really that small. I suspect that many celiacs, who eat 20 ppm foods, would do better at a lower level.

And wasn't that what the study said - that the level that caused gut damage was higher than the level that caused symptoms? It is sure a lot easier to go on symptoms than to get endoscopies all the time!
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#24 dilettantesteph

 
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Posted 27 August 2011 - 08:04 AM

As best I can tell, even a 5ppm standard won't help the super sensitives, but I am very concerned that their existence be acknowledged and accomodated in institutional settings, even if they can not participate in the modern, processed food system.

My other concern is, I've been calling them the "miniscule minority," but I wonder if the group is really that small. I suspect that many celiacs, who eat 20 ppm foods, would do better at a lower level.

And wasn't that what the study said - that the level that caused gut damage was higher than the level that caused symptoms? It is sure a lot easier to go on symptoms than to get endoscopies all the time!

So true.

I read all the time about celiacs suffering from other conditions, which I suffered from too, until I got off the standard gluten free diet.
There have also been studies published where they checked celiacs with endoscopies and a lot of them still got positives on the standard gluten free diet.

I guess the problem with going on symptoms rather than endoscopies is that is isn't scientific. It is subjective. Since there wasn't a positive endoscopy, you must not be experiencing those symptoms after all.
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#25 U Gluten Free

 
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Posted 27 August 2011 - 01:05 PM

And actually, the data is already going to be skewed before they even START the trials, when you think about it.

Because in this study - and in every one I've ever found that is looking at safe gluten levels - the researchers try to get participants who have healed on their gluten free diet. Except we all know that their gluten free diets aren't ZERO gluten. They are a certain amount of gluten.

So assuming the majority of the population eats a certain number of gluten-free products, that means that any celiacs who can't heal while eating this low level of gluten (20ppm) are automatically excluded from the study.

The only super sensitives the study is going to get are going to be those who are eating whole foods, avoiding processed gluten-free products, etc...

So we have no way of even knowing how many sensitive celiacs there may be, because we almost never get into the studies. :rolleyes:



I honestly wouldn't care sometimes, except these same studies are being used to make decisions about the celiac population as though they ARE completely representative of us. And they aren't, obviously.

Good point.
The problem may be ethical rather than technical: it may not be ethical to give gluten to people who are already known to be extremely sensitive. Each research center has an "Institutional Review Board" which reviews the risks and benefits of a given study.
A safety study is different from a therapeutic drug trial—in that case, there is an intent to improve the health of a patient (even if there is a potential risk from any new drug).
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#26 T.H.

 
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Posted 27 August 2011 - 01:54 PM

The problem may be ethical rather than technical: it may not be ethical to give gluten to people who are already known to be extremely sensitive.


Good point, as well. :-) I wonder if a more ethical study concept would be to take celiacs who are NOT healing, like those diagnosed with refractory celiac disease, and start the trial working the other way around: trying to heal them. Have some on 20mg a day, some on 10 mg a day, and some on a 'super' gluten free diet of even less than that. See if the condition improves.
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T.H.

Gluten free since August 10, 2009.
21 years with undiagnosed Celiac Disease

23 years with undiagnosed sulfite sensitivity

25 years with undiagnosed mast cell activation disorder (MCAD) 

 

Daughter: celiac and MCAD positive

Son: gluten intolerant
Father, brother: celiac positive


#27 dilettantesteph

 
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Posted 28 August 2011 - 06:47 AM

Good point, as well. :-) I wonder if a more ethical study concept would be to take celiacs who are NOT healing, like those diagnosed with refractory celiac disease, and start the trial working the other way around: trying to heal them. Have some on 20mg a day, some on 10 mg a day, and some on a 'super' gluten free diet of even less than that. See if the condition improves.

I think that it would be a great study to take people who haven't healed and put them on a diet like ours. It has worked for several of "us", but not within the confines of a study.
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#28 U Gluten Free

 
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Posted 29 August 2011 - 02:37 PM

My other concern with the safe threshold study is that it lasted for 90 days. Is that long enough?

http://www.ajcn.org/...t/85/1/160.long

The authors of this paper pointed out that there were ethical challenges in continuing a clinical trial in which intestinal damage was clearly being caused by the gluten administered to the patients.
Now that I think of it, I wonder if such a clinical trial would be approved in the US? It seems that most of these studies are done overseas.
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Peter Olins, Ph.D.

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Biochemist with 40 years experience in basic research and product development.  Developed therapies for cancer, autoimmune diseases and infectious diseases. Passionate about good food, good health, and building supportive communities.

 

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