Download Understanding Gluten Digestion

Understanding Gluten Digestion
Gluten is found most commonly in wheat and other related grains, such as barley and
rye. The word gluten comes from the Latin word for glue, and is typically defined as an
elastic protein that is left behind after starch is removed or washed away from wheat
flour. It’s the adhesive properties of gluten that allow for baked goods such as breads
and cakes to hold together, adding texture and a characteristic chewiness. The protein
properties that are responsible for the texture and chewiness also make it very strong
and hard to break down by protease enzymes in the body. Although the only grain
considered to have true gluten is wheat, gluten is also used in a wide variety of other
foods as a thickener and binder, flavor enhancer, and protein supplement.
Gluten actually consists of several different proteins – the two main groups of the
proteins in gluten are gliadin and glutenin. Gluten proteins are extremely difficult to
digest
Only certain endogenous enzymes can break down gluten, such as DPPIV, while trypsin
and chymotrypsin have little effect. For those individuals that do not make or make
enough of these specific enzymes, gluten is not broken down completely. Undigested
gluten proteins can damage the digestive tract lining and illicit an immune response,
resulting in varying levels of gluten sensitivity or just digestive discomfort. Breaking
down these proteins can help alleviate the symptoms associated with undigested gluten
and prevent further damage to the body. Proteases are enzymes that break down
proteins, but proteases that can break down prolyl-enriched peptides are required for
breaking down the proline-rich peptides from gluten. Research shows that the prolinerich peptides from gluten are the main reason for gluten sensitivity.
References
1. Camilleri M, Colemont LJ, Phillips SF, etc. Human gastric emptying and colonic filling of solids
characterized by a new method. Am J Physiol Gastrointest Liver Physiol. 257:284, 1989.
2. Proano M, Camilleri M, Phillips SF, etc. Transit of solids through the human colon: regional
quantification in the unprepared bowel. Am J Physiol Gastrointest Liver Physiol 258:856, 1990
What is Glutalytic?
Glutalytic is a proteolytic enzyme blend designed to reduce digestive discomfort
associated with gluten digestion trouble. This formulation goes beyond the traditional
DPPIV (dipeptidyl peptidase IV) enzyme, offering superior degradation of gliadin. This
unique proteolytic enzyme blend targets the internal and external peptide bonds that
make up the gluten protein.
DEGRADES GLIADIN (and its prolines fragments), the major immune eliciting protein
fraction in gluten, down from gram to milligram quantities by the time it reaches the
small intestine.
This graph is based on the ELISA R5 kit that detects the proline rich fragments. The ELISA
uses the same antibody binding that the body uses to elicit an immune response. If
there’s no detection, there’s no immune response. Note that although degradation is
strong, nothing should be claimed as 100%.
BREAKS DOWN COMPETING PROTEINS that may also be present in a gluten-containing
meal, such as milk, nuts, fish and soy– allowing the enzymes in Glutalytic to attack the
gluten proteins faster.
How does Deerland Enzymes prove Glutalytic is a safe Dietary
Supplement?
ANVISA in Brazil released a Technical Report (IT 65) recognizing enzymes and enzyme
blends (food grade) as functional ingredients.
The enzymes used in Glutalytic® are produced by non-GMO organisms and are Generally
Recognized As Safe (GRAS), listed on Health Canada’s approved enzyme list, and have a
long history of safe use as dietary supplements in the United States and other countries.
How was the efficacy of Glutalytic proven?
Three clinical studies were performed, showing a significant improvement in symptoms
associated with gluten ingestion. These studies are available to prescribers through the
ViaFarma website.
THE SCIENCE
Clinical studies show the ability of Glutalytic® to improve a variety of discomforts
associated with gluten sensitivity. Numerous in vitro studies performed under
physiological conditions have shown the superior ability of Glutalytic to break down
gluten quickly and efficiently while traveling through the stomach and upper duodenum.
In a double-blind, placebo based human clinical study, participants showed statistically
significant improvements in a wide variety of common digestive issues while taking
Glutalytic.
Enzymes for Protein Digestion
The fastest way to break down gluten is to cleave peptide bonds internally and
externally.
Glutalytic contains both endopeptidases and exopeptidases to create the correct
endopeptidase cleavage pattern near the long chain amino acids that need to be
hydrolyzed by the exopeptidase, producing rapid degradation of gluten.
In-Vitro Testing: Gel Electrophoresis
Glutalytic demonstrates a superior ability to
break down gluten quickly and efficiently
while traveling through the stomach and
upper duodenum under physiological
conditions.
Gliadin, the major immune eliciting protein
fraction in gluten, can be degraded down from
gram to milligram quantities by the time it
reaches the small intestine. Glutalytic
hydrolyzes peptide bonds from the interior
and exterior of the protein, including the
proline residues.
Glutalytic® is superior to current
gluten aids on the market today that
rely primarily on the DPPIV enzyme.
Glutalytic® helps break down large
unhydrolyzed gluten peptides into
amino acids that can be absorbed
and used by the body. The chart to
the right shows Glutalytic® compared
to a typical gluten supplement
formulation containing a majority of
only DPPIV.
Experimental Design:
 Target: Degradation during
transit time of the
stomach/upper duodenum.
 Substrate: Solids
 Endpoint: 90 minutes (avg. time significant solid content enters duodenum).
 pH: Active pH range of 4.0-7.0
When to Prescribe Glutalytic
Glutalytic shouldn´t be prescribed to patients with Celiac Disease. Glutalytic does not
contain any recombinant (GMO) enzymes and is not intended to treat a disease. It is a
dietary supplement intended to help individuals digest proteins, particularly those that
contain gluten peptides.
It is advised to adhere to the “Gluten Free” diet recommendations for individuals who
are diagnosed to be Gluten Sensitive. At the same time, we acknowledge that it is not
always possible to know with certainty that gluten may be present. This is the reason to
take Glutalytic, to help minimize the consequences of inadvertent exposure, not to
encourage the deliberate consumption of gluten.
The issue of “Sensitivity Grades” is merely an illustration of the wide range of sensitivity
between individual’s tolerance levels. It should not be viewed as “data” or construed as
coming from a clinical study. It is simply a way to illustrate the range of tolerance that
different individuals may experience. It is only an adjunct to Gluten avoidance to those
people with some level of Gluten Sensitive.
Also, there are those individuals that don’t have Gluten Sensitivity but they have
digestion discomfort when they consume gluten; these people can also benefit from
taking Glutalytic when consuming Gluten.
Does Glutalytic® break down 100% of the gliadin (and its prolines
fragments)?
*SDS PAGE and ELISA tests description are also available to prescribers at Via Farma
website.
Gluten Digestion without Endogenous Enzymes
Glutalytic’s gluten degrading efficacy was directly compared against two market
products (Sample A and Sample B) without the addition of endogenous enzymes. A
gluten substrate was prepared in 70% ethanol. The solution was then stirred at room
temperature for thirty minutes to allow time for the gluten to fully dissolve. The solution
was then filtered through a Whatman #1 filter paper. An aliquot of the filtered solution
was then added to phosphate buffer (pH 7.0, 20 mM).
Samples were prepared for respective enzyme blend in phosphate buffer. For the
reaction, aliquots of the substrate preparation were transferred to Erlenmeyer flasks. A
sample of each enzyme preparation was then added to the respective flask containing
the substrate preparation. All three samples were placed in a 37°C shaker water bath to
incubate. In order to record digestion of time, aliquots of the solution were removed,
sequestered in labeled centrifuge tubes, and placed in a boiling water bath for five
minutes to stop the digestion at time points 0, 30, 60, and 90 minutes, beginning when
the enzyme samples were added to the gluten substrate. All samples were assayed
using the Veratox Gliadin R5 ELISA Kit (Neogen, Lansing).
Gluten Digestion with Endogenous Enzymes
Glutalytic’s gluten degrading efficacy was directly compared against two market
products (Sample A and Sample B) with the addition of endogenous enzymes. A gluten
substrate was prepared in 70% ethanol. The solution was then stirred at room
temperature for thirty minutes to allow time for the gluten to fully dissolve. The solution
was then filtered through a Whatman #1 filter paper. The gluten substrate was diluted
using deionized water. Simulated gastric fluid (NaCl, pepsin, HCl), intestinal fluid
(potassium phosphate, pancreatin, NaOH), and pancreatic fluid (sodium bicarbonate
and sodium dodecyl sulfate) were prepared.
Samples for this experiment were prepared by dissolving for respective enzyme blend in
phosphate buffer. Aliquots of the gluten substrate preparation were transferred into
Erlenmeyer flasks. A sample of each enzyme preparation was added to the respective
flasks. All three samples were placed in a 37°C shaker water bath to incubate. At time 0,
an aliquot of the digestion solution was transferred to a microcentrifuge tube containing
deionized water and placed in a boiling water bath for five minutes to stop the
digestion.
At time points 0, 3, 6, 9, and 12 minutes, of gastric fluid was added to each flask. After
15 minutes of digestion, an aliquot of digestion solution was transferred into a
microcentrifuge tube containing deionized water and placed in a boiling water bath for
five minutes to stop digestion. Additionally, pancreatic fluid was added to each flask.
Following the addition of the pancreatic fluid, intestinal fluid was added to each flask
every five minutes until a total reaction time of 90 minute was achieved. After 30
minutes of digestion, an aliquot of digestion solution was transferred to a
microcentrifuge tube containing deionized water and placed in a boiling water bath for
five minutes to stop the digestion. After 60 minutes of digestion, an aliquot of digestion
solution was transferred to a microcentrifuge tube containing deionized water and
placed in a boiling water bath for five minutes to stop the digestion. After 90 minutes of
digestion, a final aliquot of digestion solution was transferred to a microcentrifuge tube
and placed in a boiling water bath for five minutes to stop the digestion. All samples
were assayed using the Veratox Gliadin R5 ELISA Kit (Neogen, Lansing).
What is the recommended dosage, and when should one take Glutalytic?
Glutalytic should be taken during the meal (you can take just after it but the efficiency
will reduce as the time goes longer). We recommend 345 mgr of Glutalytic in a capsule
for each 10 grams of gliadin. But, it will depend on each patient capacity to digest
Gluten.
What is the dosage for children?
They should consult their physician.
Can pregnant women take Glutalytic?
They should consult their physician.
Does enzyme supplementation, like with Glutalytic, make the body stop producing
enzymes?
No, supplemental enzymes have been used for decades (same ones that used in both of
the products above) and there is no evidence of reduction of endogenous enzymes.
Exogenous enzyme supplementation may result in some reduction of the endogenous
enzyme secretion. Once supplementation ceases, endogenous enzyme production will
return to normal production levels. These levels are dependent on several factors, such
as age, diet, general and digestive system health.
You can check several studies available at
http://deerlandenzymes.com/resources/reference-studies/
How do enzyme preparations, like Glutalytic, work in the body?
Enzymes are produced by the body for digestion of the food consumed. Pancreatic
enzymes, produced in the pancreas, contain Proteases (which digest proteins), AlphaAmylase (which digests starch) and Lipase (which digests lipids or fats). Supplemental
enzymes can augment the activity of these endogenous enzymes and provide additional
digestive support for foods that are not broken down sufficiently by some individuals.
The Proteolytic enzymes in Glutalytic have a high affinity for gluten and assist with the
rapid hydrolysis of the proteins in gluten containing foods to help reduce the gluten
peptides responsible for Gluten Sensitivity.
What happens to the enzymes after they hydrolyze the specific substrate?
All enzymes are proteins but not all proteins are enzymes. Enzymes are a special class of
proteins that possess the ability to catalyze biochemical reactions. This is critical for
metabolism and the relatively mild conditions in the human system. The body is very
homeostatic and maintains tight control over temperature, pH and concentrations of
various substances. Once the enzymes have reacted with their respective substrates and
formed products of that reaction, they continue to react as long as substrate is available
and conditions allow. They are eventually metabolized and absorbed or eliminated.
How should Glutalytic be storage by patients?
Enzymes are sensitive to heat and moisture. It means, in a proper storage condition, the
shelf-life is 24 months. If it is submitted to improper storage conditions, it can lose
potency, therefore its efficiency will be reduced.


If you are in Climatic Zone III (< 25oC and 40% humidity), store Glutalytic in an
airtight container, avoiding light and moisture.
If you are in Climatic Zone IV (<30oC and 60% humidity), store Glutalytic in an
airtight container away from light and moisture and refrigerated from 2 - 8°C
(regular refrigerator).
You can take the amount you will consume during the day with you in a small drug
container.
Who is the company and science behind Glutalytic?
Deerland Enzymes is a global leader in Enzyme related Dietary Supplements supplier.
Deerland produces more than 70% of all Enzyme Dietary Supplements sold in the USA
and Canada. Deerland Enzymes is a leading specialty formulator and contract
manufacturer of enzyme- and probiotic-based dietary supplements. With a team of
industry experts working in a state-of-the-art lab, we’re e design phase, final
formulation and contract manufacturing and contract manufacturing. The Deerland
Enzyme manufacturing plants and R&D are located in Kennesaw, near Atlanta, GA. At
Deerland Enzymes, we take pride in the science-supported dietary supplement
formulations we develop with our customers. Although we specialize in customized
formulations, we have also developed an exclusive line of university-studied products
which can be used as-is, or as the basis for a custom formulation. Our Ph.D. and M.D.
led research and product development teams are on top of the latest technological
developments and supplement market trends, delivering the most advanced product
lines available.
University Alliances
Deerland Enzymes has alliances with several respected universities, collaborating
through clinical research based on each institution’s specific area of expertise.
Regulatory Alliances
Our relationships with regulatory consultants and other industry leaders
ensure Deerland Enzymes and our customers stay abreast of any
changes that may affect the dietary supplement industry.
Technical Alliances
AOAC
Deerland Enzymes’ VP of Technology, Dr. John Deaton, and Director of QC
Maggie Leroux are active members of AOAC International, a globally
recognized association whose members are comprised of government
agencies, academia, international organizations, contract research organizations, rapid
assay developers, high technology providers and instrument manufacturers. AOAC’s
primary activity is the development of globally accepted standards to support its mission
to attain the vision of “worldwide confidence in analytical results”.
Industry Trade Associations
Enzyme Technical Association (ETA)
Deerland Enzymes is a proud member of the Enzyme Technical Association
(ETA), a trade association which has taken an active role in assisting in the
development of regulations and policies that affect the enzyme
industry. Scott Ravech, CEO of Deerland Enzymes, serves as the chair of the ETA’s
dietary supplements committee.
Council for Responsible Nutrition (CRN)
The Council for Responsible Nutrition (CRN) is the leading trade
association representing dietary supplement manufacturers and
ingredient suppliers. As a member of CRN, Deerland Enzymes voluntarily
adheres to a strong code of ethics and manufacturing standards.
International Probiotics Association (IPA)
The International Probiotics Association (IPA) is an international
organization with members equally divided between industry and
academia and its goal is to provide a unique forum for the exchange of
research and the latest breakthroughs in probiotic technology and new product
development.
Canadian Health Food Association (CHFA)
Deerland Enzymes is a member of the Canadian Health Food
Association (CHFA), Canada’s largest trade association dedicated to
natural health and organic products.
Coalition for Supplement Sustainability
Deerland Enzymes is a founding member of the Coalition for
Supplement Sustainability, a member-driven trade association of the
dietary supplement industry, established to maintain sustainable,
independently verifiable and transparent standards across the entire
supplement supply chain.
QUALITY ASSURANCE
Deerland Enzymes boasts two separate quality functions to better serve customers’
needs:
 Quality Assurance (QA), responsible for all process-based quality initiatives:
GMP certification, batch records, document control and regulatory.
 Quality Control (QC), responsible for all lab-based functions: microbiological
testing, assays, identify testing and all other facets of technical support, including
R&D.
QUALITY CERTIFICATIONS
GMP Certified through NSF for Dietary and Sport
NSF is a third party, international Good Manufacturing Practices (GMP)
certification organization. GMP registration from NSF International
verifies that Deerland Enzymes’ facility has the proper methods,
equipment, facilities, and controls in place for producing dietary
supplement products. The NSF GMPs were developed in accordance
with the U.S. Food and Drug Administration’s (FDA) 21 CFR part 111 regulation on
dietary supplement manufacturing, packaging, and distribution. Utilizing GMP guidelines
assists companies in developing and maintaining proper controls in their manufacturing
process so that products are processed, manufactured and labeled in a consistent
manner, and meet quality standards.
Kosher, Star-K
Star-K is recognized globally as the most trusted kosher symbol. The
Kosher Certification verifies that Deerland Enzymes’ facility is approved
for the manufacture of products that meet strict Kosher requirements.
Halal, Islamic Services of America
ISA is the oldest and most respected Halal Certifier in North America.
The Halal Certification verifies that Deerland Enzymes’ facility is
approved for the manufacture of products that meet strict Halal
requirements.
Feed Additives and Premixtures Quality System (FAMI-QS)
This state-of-the-art quality certification is the only certifiable code
specific for specialty feed ingredients and their mixtures, and is
awarded only to those companies that exemplify the highest quality
standards during production. The FAMI-QS code is designed for
international validity, providing a single reference for ensuring the
quality and safety of feed additives.
National Animal Supplement Council
NASC is a non-profit trade organization dedicated to protecting and
enhancing the health of companion animals and horses throughout the
United States. Its membership includes manufacturers of finished
products as well as raw material suppliers, distributors, veterinarians
and retailers. NASC’s Preferred Supplier program ensures that
suppliers of raw materials meet comprehensive standards for testing and other
specifications to ensure its members can buy from trusted companies.
MEET OUR EXPERTS
In House Expertise
Dr. John Deaton, Ph.D.
Vice President of Science & Technology
With a Ph.D. in Biochemistry and more than 18 years of
experience, leads research and development of new product
innovations.
John Davidson
Director of Product Development
A 30-year veteran of the enzyme supplement industry, leads the
development of new product formulations.
Maggie Leroux
Director of Quality Control
An expert in cGMP and USP testing procedures with a degree in
Biology from the University of Georgia, leads the Quality Control
laboratory.
World Renowned Expertise
Dr. Theodore Hersh, MD
Thione International
Product Development Alliance
With more than 30 years of academic, medical practice and
research experience as a gastroenterologist-hepatologist,
contributes medical and technical consulting on the physiological
effects of Deerland Enzymes products. Graduated by Harvard
College, obtained its MD from Columbia University and post-graduate by Mayo Clinic.
John Davidson, Director of Product Development, Deerland Enzymes
John Deaton, VP Science & Technology, Deerland Enzymes
4/25/16
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