GliadinX/Tolerase G

[Fenrir]

I was just curious if anyone has found an article or study that tells what the effective dose is for this product?

I'm soon to be a personal trainer and have been researching supplements for fitness uses. I know from this research that there are some supplements that do help build muscle and they are proven by science (creatine, Beta-Alanine..ect). However, the problem with buying supplements is that the manufacturers typically under dose the product according to what the studies done show the dose should be. 

So with these two supplements I've been unable to find anything that says dose used in the studies were so when buying these products we can make sure the dose is correct. 

[cyclinglady]

You should look into liability  insurance as a trainer, unless the gym you work at covers you.    Unless you have a degree and/or certification as a dietician or nutritionist (and are insured), you probably should not dispense any medical related dietary advice at all to anyone is is not perfectly healthy.   Every fitness training I have taken strongly recommends not recommending diets, but then I reside in California and must follow the law.  Check your state for clarification on laws pertaining to this subject.  

[Fenrir]

2 minutes ago, cyclinglady said:

You should look into liability  insurance as a trainer, unless the gym you work at covers you.    Unless you have a degree and/or certification as a dietician or nutritionist (and are insured), you probably should not dispense any medical related dietary advice at all to anyone is is not perfectly healthy.   Every fitness training I have taken strongly recommends not recommending diets, but then I reside in California and must follow the law.  Check your state for clarification on laws pertaining to this subject.  

Yes, I'm aware of all of that. The purpose of this isn't to give clients suggestions on supplements. I'm just stating that while studying for my PT certification I came to find out supplements are under dosed so I was curious about the actual dose used in the studies for the enzyme products. 

I'm well aware of the insurance/liability and am also pursuing a certification in nutrition as well. This topic was just for my own use.  

[Scott Adams]

I've spoken directly with the developer about the product. AN-PEP is well tolerated and has been used in the brewing industry for many years as a clarifying agent in the beer brewing process. I do believe his recommended dosage was created directly from the studies that were done. He has also said that there are no known issues with doubling to tripling the dosage in cases where accidental gluten is consumed, which happened to my mother--she took 4 or 5 after accidentally consuming a regular gluten piece of pie (how could this have happened in my house?!).

[Fenrir]

10 minutes ago, Scott Adams said:

I've spoken directly with the developer about the product. AN-PEP is well tolerated and has been used in the brewing industry for many years as a clarifying agent in the beer brewing process. I do believe his recommended dosage was created directly from the studies that were done. He has also said that there are no known issues with doubling to tripling the dosage in cases where accidental gluten is consumed, which happened to my mother--she took 4 or 5 after accidentally consuming a regular gluten piece of pie (how could this have happened in my house?!).

Yes, I was just wondering what the doses were that were given to the test subjects because it doesn't say in any of the studies. Having studied nutritional/fitness supplements extensively many of them either don't contain the amount listed on the bottle or the dose in the supplement uses is significantly less than the studies showed were an effective dose. 

So, when working in the fitness space I've always went to look at the studies to see the doses used to see if the supplement will actually do what it says. So, just curious if we know the doses used in any of the studies. If we don't see what they used in the study it's not very transparent, IMO. I've learned to be skeptical about supplements of any kind, just through experience. 

[Scott Adams]

I'll see if the owner of GliadinX will chime in here...

[docaz]

Hi, I have been made aware of this thread and I have formulated GliadinX in response to 2 of my children having been diagnosed with celiac disease about 8 years ago.

Right of the bat, I would like to emphasize that even if there is a large number of studies showing that AN-PEP/GliadinX breaks down gluten (gliadin) I do not want to encourage anybody to be non-compliant with a physician prescribed gluten-free diet. At the same time, all experts in the field are in agreement that a gluten-free diet without any incidence of cross-contamination or accidental consumption is unrealistic and only attainable in almost social isolation. I encourage people to print out the articles that are posted on the GliadinX page and discuss with their doctors because unfortunately many doctors are not aware of the peer reviewed publications in reputable journals showing the efficiency of AN-PEP. The first studies that I am aware of are from 2006 and there were several after that. There are clinical and laboratory studies. The clinical studies show that large amounts of gluten have been completely neutralized before they entered the small intestine. This was done by taking samples from a tube that went from the nose into the stomach and into the small intestine. No residual gluten was measured when given together with the enzymes. Critics of this study are concerned that the study was done on healthy volunteers and not on celiac patients, but this was done for ethical reasons and the enzymatic activity is not dependent on the patient having celiac disease because the breakdown happens completely within the stomach. I have been in touch with the researchers for about 7 years and the calculated  amount of gluten that is broken down by 1 g of AN-PEP is about 2.4 g of gluten. More cautious suggestion like a publication from the University of Chicago limit the amount of gluten that can be broken down to about 1/8 of a slice of bread which is about 0.3 g but I do not know how that limitation was calculated because previous studies showed digestion of much larger quantities. Regardless, 1/8 of a slice of bread is much more than any cross contamination and not to have to worry of that, has a significant positive impact on the everyday life.  

GliadinX takes also advantage of a study that shows that AN-PEP has a much faster effect in an acidic environment and this is important because the gluten has to be broken down fast while it is in the stomach and before it makes contact with the lining of the small intestine and leaks into the wall (leaky gut disease). 

I am posting here 2 links to studies that show the amount of gluten used

This study used 5.2 g of gluten (equivalent to 2 large slices of bread) of which 4g was the gluten protein and 1,600,000 PPI AN-PEP was added which is about 3 g of AN-PEP (which is quite a lot) 

https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.13266

 

This is a study in the most sophisticated simulated gastro-intestinal model. It was tested multiple ways including one test with a 70 g piece of bread containing 5 gm of gluten to which 1 g of pure enzyme was added. Controls were performed with out the enzymes. The controls showed significant T-cell proliferation reaction while the experiment with the enzymes showed no T-cell proliferation reaction. 

https://www.researchgate.net/publication/6338053_Efficient_degradation_of_gluten_by_a_prolyl_endoprotease_in_a_gastrointestinal_model_Implications_for_coeliac_disease

There are many more studies and I will gladly discuss them if there is interest. 

 

 

[Fenrir]

10 hours ago, docaz said:

Hi, I have been made aware of this thread and I have formulated GliadinX in response to 2 of my children having been diagnosed with celiac disease about 8 years ago.

Right of the bat, I would like to emphasize that even if there is a large number of studies showing that AN-PEP/GliadinX breaks down gluten (gliadin) I do not want to encourage anybody to be non-compliant with a physician prescribed gluten-free diet. At the same time, all experts in the field are in agreement that a gluten-free diet without any incidence of cross-contamination or accidental consumption is unrealistic and only attainable in almost social isolation. I encourage people to print out the articles that are posted on the GliadinX page and discuss with their doctors because unfortunately many doctors are not aware of the peer reviewed publications in reputable journals showing the efficiency of AN-PEP. The first studies that I am aware of are from 2006 and there were several after that. There are clinical and laboratory studies. The clinical studies show that large amounts of gluten have been completely neutralized before they entered the small intestine. This was done by taking samples from a tube that went from the nose into the stomach and into the small intestine. No residual gluten was measured when given together with the enzymes. Critics of this study are concerned that the study was done on healthy volunteers and not on celiac patients, but this was done for ethical reasons and the enzymatic activity is not dependent on the patient having celiac disease because the breakdown happens completely within the stomach. I have been in touch with the researchers for about 7 years and the calculated  amount of gluten that is broken down by 1 g of AN-PEP is about 2.4 g of gluten. More cautious suggestion like a publication from the University of Chicago limit the amount of gluten that can be broken down to about 1/8 of a slice of bread which is about 0.3 g but I do not know how that limitation was calculated because previous studies showed digestion of much larger quantities. Regardless, 1/8 of a slice of bread is much more than any cross contamination and not to have to worry of that, has a significant positive impact on the everyday life.  

GliadinX takes also advantage of a study that shows that AN-PEP has a much faster effect in an acidic environment and this is important because the gluten has to be broken down fast while it is in the stomach and before it makes contact with the lining of the small intestine and leaks into the wall (leaky gut disease). 

I am posting here 2 links to studies that show the amount of gluten used

This study used 5.2 g of gluten (equivalent to 2 large slices of bread) of which 4g was the gluten protein and 1,600,000 PPI AN-PEP was added which is about 3 g of AN-PEP (which is quite a lot) 

https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.13266

 

This is a study in the most sophisticated simulated gastro-intestinal model. It was tested multiple ways including one test with a 70 g piece of bread containing 5 gm of gluten to which 1 g of pure enzyme was added. Controls were performed with out the enzymes. The controls showed significant T-cell proliferation reaction while the experiment with the enzymes showed no T-cell proliferation reaction. 

https://www.researchgate.net/publication/6338053_Efficient_degradation_of_gluten_by_a_prolyl_endoprotease_in_a_gastrointestinal_model_Implications_for_coeliac_disease

There are many more studies and I will gladly discuss them if there is interest. 

 

 

Thanks! That pretty well answers my question. 

I did some looking around and found several studies that showed it was effective but just didn't stumble across one that mentioned the dose used. I could have missed it though. 

Also, it's great your product is dosed correctly. I'm seeing that many products for this purpose on the market that are essentially 100mg doses when it seems like closer to 300mg is probably better. Yeah, you could just take 3 pills of the lower dosed product but that's going to cost more and also people assume the dose on the bottle is effective so some people will not get the effect they advertise. 

 

 

[cyclinglady]

23 hours ago, Fenrir said:

Yes, I'm aware of all of that. The purpose of this isn't to give clients suggestions on supplements. I'm just stating that while studying for my PT certification I came to find out supplements are under dosed so I was curious about the actual dose used in the studies for the enzyme products. 

I'm well aware of the insurance/liability and am also pursuing a certification in nutrition as well. This topic was just for my own use.  

Great!  My insurance radar is on this week.  I am paying for all our insurance (we are self-employed) and it is...I can not find the words, but frustrating is one of them!  

Good luck on your certifications!  ?

[Fenrir]

1 minute ago, cyclinglady said:

Great!  My insurance radar is on this week.  I am paying for all our insurance (we are self-employed) and it is...I can not find the words, but frustrating is one of them!  

Good luck on your certifications!  ?

Well luckily, the insurance require to be a personal trainer isn't very expensive. 

[Fenrir]

@docaz @Scott Adams

Just placed placed an order for GliadinX. We will be traveling in the next few months and I always end up having to eat out at places that I can't 100% trust not to cross contaminate and I've been glutened before. This will be a good thing to try and see if helps avoid reactions that inevitably happen in spite of our best efforts to avoid it. 

 

[Scott Adams]

Travelling is always a challenge, but another of the things in life, like eating out, that I simply won't give up. There is a reason I moved to wine country California--wine and good restaurants!

I hope you'll be on here during your travels...keep us posted on how everything goes!

[Scott Adams]

Also, I just wanted to address a couple of things about enzymes. I get routinely criticized for endorsing them because the major support groups haven't fully endorsed their use.

I am not sure how much science it takes for them to finally jump on the band wagon, but I've personally seen enough regarding AN-PEP to convince me that: 1) Taking them can't harm a celiac, other than the cost of paying for them, and 2) The scientific evidence shows that they work for surprisingly large amounts of contamination, which could potentially protect any celiacs and gluten sensitive individuals who are trying to maintain a gluten-free diet.

Taking 1-2 before eating out, going to a work party, etc., AND trying to avoid gluten seems like a far better option for people like me who won't give up eating out (there are many of us), or who travel (there are many of us)...basically people who want to live a more normal life like they had before they were diagnosed.

Many criticize the companies who sell them because they don't go the prescription drug route and pass a much higher level of scientific scrutiny. This process often takes up to 10 years or more, and costs tens of millions of dollars. So far there is no prescription drug for celiac disease that has passed this process, although there are some like Larazotide Acetate (formerly AT 1001), which we've been writing about now for over 10 years, that are getting closer. It could eventually become a prescription drug in a few more years...a full 15 years after it was discovered. In the end it has nearly the same application--it won't allow you to eat gluten again, and you would take it to avoid cross-contamination. I guarantee it will be far more expensive than GliadinX or others that use AN-PEP, and it will probably have more side-effects associated with it due to how it works.

The reason nobody would ever invest the money to do this with AN-PEP is simple...it is widely available and has been used as a clearing agent in the beer brewing industry for many years. Any patent on it may not even be valid anymore, or would expire long before this process would complete, and at the same time it would already be widely available and inexpensive, so why would anyone invest in this process?

[Fenrir]

27 minutes ago, Scott Adams said:

Also, I just wanted to address a couple of things about enzymes. I get routinely criticized for endorsing them because the major support groups haven't fully endorsed their use.

I am not sure how much science it takes for them to finally jump on the band wagon, but I've personally seen enough regarding AN-PEP to convince me that: 1) Taking them can't harm a celiac, other than the cost of paying for them, and 2) The scientific evidence shows that they work for surprisingly large amounts of contamination, which could potentially protect any celiacs and gluten sensitive individuals who are trying to maintain a gluten-free diet.

Taking 1-2 before eating out, going to a work party, etc., AND trying to avoid gluten seems like a far better option for people like me who won't give up eating out (there are many of us), or who travel (there are many of us)...basically people who want to live a more normal life like they had before they were diagnosed.

Many criticize the companies who sell them because they don't go the prescription drug route and pass a much higher level of scientific scrutiny. This process often takes up to 10 years or more, and costs tens of millions of dollars. So far there is no prescription drug for celiac disease that has passed this process, although there are some like Larazotide Acetate (formerly AT 1001), which we've been writing about now for over 10 years, that are getting closer. It could eventually become a prescription drug in a few more years...a full 15 years after it was discovered. In the end it has nearly the same application--it won't allow you to eat gluten again, and you would take it to avoid cross-contamination. I guarantee it will be far more expensive than GliadinX or others that use AN-PEP, and it will probably have more side-effects associated with it due to how it works.

The reason nobody would ever invest the money to do this with AN-PEP is simple...it is widely available and has been used as a clearing agent in the beer brewing industry for many years. Any patent on it may not even be valid anymore, or would expire long before this process would complete, and at the same time it would already be widely available and inexpensive, so why would anyone invest in this process?

Yes, I have a background in medical labs so I understand chemistry and how to interpret research articles. The studies published on AN-PEP show stronger evidence than some prescription drugs (not celiac disease related) have. For instance, Statins (for cholesterol) are roughly as effective in reducing cholesterol as AN-PEP is in reducing gluten. Also, statins have a lot of side-effects, AN-PEP doesn't. Interestingly enough Drs. still recommend a low cholesterol diet even if on statins. Why? Statins aren't a cure either. Dietary compliance is also a big factor, maybe not as much as for Celiac Disease though.

The reason AN-PEP isn't prescription is because there's little money in it. Sure, a smaller company could probably make nice earnings on it but these giant pharmaceutical companies aren't manufacturing anything so relatively easy and cheap to make. It would be like making aspirin a prescription drug, but only useful for maybe 5-10% of the population at most. There's not enough of market to sell something this inexpensive from big pharma point of view. Now if it was an actual cure, yeah, they'd be all in because every Celiac and gluten sensitive person on the planet would want it. 

Personally, I'm glad it's not a prescription because it would be much more expensive and instead of just ordering it online I'd have to go to the Dr. , then go to the pharmacy and hope my insurance covers it. 

There's absolutely nothing wrong with recommending this as a something of a prophylactic when you don't completely control the food prep. Of course you don't want to intentionally eat gluten but there are times you will not have control over cross contamination unless you're a hermit and never leave home.

[Scott Adams]

Agreed. I also used to run polls regularly on this site and ~25% of diagnosed celiacs reported that they routinely cheated on their diet. I'm embarrassed to say that my own teenage daughter, who went gluten-free about a year ago (she's gluten sensitive with symptoms and high, but not high enough antibody levels--just under the cutoff to be offered a biopsy), occasionally cheats on her diet. As you can imagine...as the founder of Celiac.com I'm basically mortified, and lecture her about it, but the reality is that she is going to do what she wants whether I like it or not. To my relief I was able to get her to agree that whenever she cheats, which she never should, that she takes an increased number of GliadinX capsules according to whatever she ate (a piece of pizza = 4). 

Again, this of course is not the recommended use, but she is not alone as many people do cheat regularly, and for my daughter it is about twice a month, usually due to peer pressure situations from her friends or fellow players on her high school soccer team. She's had no symptoms so far, and I'll be getting her a follow up blood test soon to see how this is going.

[docaz]

On 1/24/2020 at 12:55 PM, Scott Adams said:

 

Many criticize the companies who sell them because they don't go the prescription drug route and pass a much higher level of scientific scrutiny. This process often takes up to 10 years or more, and costs tens of millions of dollars. So far there is no prescription drug for celiac disease that has passed this process, although there are some like Larazotide Acetate (formerly AT 1001), which we've been writing about now for over 10 years, that are getting closer. It could eventually become a prescription drug in a few more years...a full 15 years after it was discovered. In the end it has nearly the same application--it won't allow you to eat gluten again, and you would take it to avoid cross-contamination. I guarantee it will be far more expensive than GliadinX or others that use AN-PEP, and it will probably have more side-effects associated with it due to how it works.

 

Scott, you touched upon something that is very true and possibly the reason why there will never (or at least for many years to come) be an FDA approval for a product that will have an indication to be taken to allow someone to eat gluten.

In order for a product to go through the FDA process it has be first prove that it is safe in humans and that it is effective. An attempt to clear ALV003 (an enzyme combination of 2 enzymes acting similarly to AN-PEP) through the FDA failed because the study compared to a placebo and the study did not show any benefits vs the placebo. The study was ill designed because it was much too short. In order for a celiac study to be meaningful, it has to be conducted over a very long period of time because the inflammatory reaction goes away very, slowly over 6 months or more and it also kicks in very slowly. The study was a gluten challenge study and the patients did very well even when they ingested gluten but so did the patients taking the placebo because of the short period of time. Sometimes, celiac patients who have been on a gluten-free diet and introduce gluten again, do not react for years. Besides the fact that such a study is extremely expensive, this presents a very big challenge because it is almost impossible to control the diet of anybody over such a long period of time. 

From a personal perspective, I see the positive impact on my own socially very active children not having to worry every time to eat outside of the house and their blood tests have stayed in the low normal range for about 6 or 7 years and I wished others could have the same benefits but I understand that there is a lot more work to be done to convince the key opinion leaders about the benefits (and I am working on that). 

 

[docaz]

On 1/24/2020 at 8:40 AM, Fenrir said:

Thanks! That pretty well answers my question. 

I did some looking around and found several studies that showed it was effective but just didn't stumble across one that mentioned the dose used. I could have missed it though. 

Also, it's great your product is dosed correctly. I'm seeing that many products for this purpose on the market that are essentially 100mg doses when it seems like closer to 300mg is probably better. Yeah, you could just take 3 pills of the lower dosed product but that's going to cost more and also people assume the dose on the bottle is effective so some people will not get the effect they advertise. 

 

 

Thank you for noticing that. I did pack as much AN-PEP as possible into the capsule without other ingredients except a flow agent to allow the capsule to be filled better and a small percentage of a food grade acid that has proven to greatly increase the activity.

It makes the product slightly more expensive but one capsule is only about 50cents and while for contamination a lower dosage of 100mg might be enough, we know that accidental exposure can happen and the difference to make it less potent was not worth it in my opinion.

[dbyers15]

I love this product. I was diagnosed over 15 years ago and have cheated throughout due to eating out and being at a friends for dinner and embarrassed to say something etc. And adding this to the mix has changed the end result for me. I am able to tolerate some gluten as long as I take these pills. They are a staple in my cabinet!! Thank you!