In August 2009, a grant was provided, and clinical investigation
was initiated in order to determine the Mechanisms of
Action and Clinical Perimeter as well as the
Pathobiochemical and Clinical Chemical Aspects of
a recently developed form of protein designed to encompass
the principles of Nutritional Genomics.
Wherein said composition was submitted to the Glycemic
Research Institute® for independent clinical trial
analysis, under the government Certification program, and
identified as a Protein-Glycoside-Matrix (herein
the “Test Food”);
The final Investigative Trials Report will summarize the clinical
findings related to the Test Food, which include Glycemic
Index and Load, Diabetic Index, Adipose Fat-Storage Index,
LPL, protein synthesis and metabolism, bioactivity, contractile
proteins, anti-ketogenic mechanism, postprandial utilization
of dietary nitrogen, protein availability, protein signaling,
and transcription and translation pathways.
Board Approved Human In Vivo Clinical Trials, as well as Analytical
Laboratory Trials, including High-Performance Anion Exchange
Chromatography, will be conducted by the Glycemic Research
Institute® and provided as a Addendum to the report.
DESCRIPTION OF THE TEST FOOD
The Test Food submitted is defined as “A Protein-Glycoside-Matrix
comprised of complete biological molecules in a stable
conformation that are assembled from amino acids using information
encoded in genes. Each protein has its own unique amino acid
sequence that is specified by the nucleotide sequence of the
gene encoding this protein. The Protein-Glycoside-Matrix
(PGM) was further identified as “A molecular network
comprised of glycoside molecules bound to specific proteins”
that is protected by a United States Patent.
Upon analytical assay of the ingredients and compound, this
description is determined to be technically and scientifically
accurate, and the Test Food is determined to be safe for
use in humans, which qualifies for participation in Human
In Vivo Clinical Trials in Diabetics and Non-Diabetics.
METABOLIC DYNAMIC & PROPERTIES
Test Food, Protein-Glycoside-Matrix, contains biologically
active components bound to protein molecules. Biologically
active refers to natural compounds that affect
the life processes of a human organism in a beneficial manner.
The metabolic dynamic of the Protein-Glycoside-Matrix
(PGM) composition appears to be multifaceted, and includes
the stimulation of muscle protein synthesis (MPS) which provides
positive net protein balance, resulting in hypertrophy, in
an Anti-Ketogenic Matrix.
glycosides in Protein-Glycoside-Matrix (PGM) lengthen
the biological life of a protein molecule by decreasing the
protein's rate of clearance from the blood. Additionally,
the Protein-Glycoside-Matrix (PGM) compound helps
the protein to fold properly, to stabilize the protein
molecules, and to provide bioactivity.
The hypertrophic advantages in muscle-mass are evidenced in
response to acute administration (short-term), and is particularly
evidenced when administered orally over a chronic term (long-term).
Hypertrophy is defined as the increase in the volume of
an organ or tissue due to the enlargement of its component
cells. Muscle Hypertrophy is the increase in muscle tissue
evidenced in response to stimuli.
of the two most common and visible forms of organ hypertrophy
occurs in skeletal muscles in response to strength training
(known as muscle hypertrophy), and in response to oral ingestion
of contractile proteins.
proteins participate in contractile processes, and include
muscle proteins as well as those found in other tissues
and cells in the body. These proteins partipate in localized
contractile events in the cytoplasm, in motile activity, and
in cell aggregation.
administration of the Protein-Glycoside-Matrix results
in significant gains in contractile protein content and
muscle strength in humans. Additionally, a dose of 10 grams
of protein enhances the inhibition of protein breakdown.
IMPROVED POST-PRANDIAL UTILIZATION
OF DIETARY NITROGEN
Whey proteins, including isolates, as well as most anabolic
proteins, are considered “Fast Proteins.”
Fast Proteins are contraindicated in the anabolic
state, as they induce over-rapid delivery of amino acids,
which cannot support the anabolic requirement throughout the
Slowly digested proteins (Slow Proteins) induce superior
post-prandial utilization of dietary nitrogen than rapidly
digested protein (Fast Proteins), despite the high chemical
score of MSPI. The Test Food (Protein-Glycoside-Matrix)
appears to metabolically switch whey proteins from
acting like Fast Proteins to acting like Slow
Protein-Glycoside-Matrix (PGM) contains Patented
anabolic amino acids and proteins, including natural
Branched Chain Amino Acids (BCAAs), which are used to fuel
working muscles and stimulate protein synthesis. The essential
amino acids, found in Protein-Glycoside-Matrix (PGM),
combined with glucose availability, is sensed by both AMPK
and mTOR in human muscle, which enhances AKT/mTOR signalling
to key regulators of translation initiation and elongation,
thus inducing a potent and rapid increase in the rate of muscle
In humans, rapamycin (mTOR) and AMP-activated protein kinase
(AMPK) are important nutrient and energy-sensing and signalling
proteins in skeletal muscle. AMPK activation decreases muscle
protein synthesis by inhibiting mTOR signalling to regulatory
proteins associated with translation initiation and elongation.
The specific amino acids found in Protein-Glycoside-Matrix
(PGM) stimulate mTOR signalling and protein synthesis. These
anabolic nutrients are sensed by both AMPK and mTOR, resulting
in an acute and potent stimulation of human skeletal muscle
protein synthesis via enhanced translation initiation and
elongation. The Protein-Glycoside-Matrix (PGM) compound
plays a key role in initiating the transcription pathway
that fires up protein synthesis, which stimulates protein
synthesis and aids in speeding recovery and adaptation to
KETOSIS & CORTISOL: NEGATIVE METABOLIC
Ketosis (from the root word ketones) is produced in the liver
through the incomplete breakdown of fat. Unlike other
proteins, the Test Food, Protein-Glycoside-Matrix (PGM)
exhibits Non-Ketogenic properties. This is an extremely important
facet in protein formulating, due to the negative physical
events triggered by both Ketosis and Cortisol.
Ketosis is a buildup of partially broken-down fats (ketones)
in the bloodstream and may occur if less than 50-100 grams
of carbohydrates are consumed each day, or if protein
is consumed without carbohydrates. As a result of
ketone build-up in the blood, the body may produce high levels
of uric acid, which is a risk factor for developing gout and
For pregnant women and people with diabetes or kidney disease,
ketosis is especially dangerous.
SPARING PROTEINS & PREVENTING KETOSIS
has demonstrated that proteins and protein products that do
not contain any carbohydrates, just protein, are ketogenic.
This is metabolic suicide for protein metabolism and homeostasis.
Proteins without carbohydrates instigate a ketogenic state
are mandatory in protein synthesis
a regular intake of carbohydrates will prevent protein
from being used as an energy source. Further, an adequate
amount of carbohydrates prevents the degradation of skeletal
muscle and other tissues such as the heart, liver, and kidneys.
The Test Food, Protein-Glycoside-Matrix, allows gluconeogenesis
to slow down, allowing amino acids to be freed for the biosyntheses
of enzymes, antibodies, receptors and other important proteins.
More importantly, it prevents ketosis.
the brain will adapt to using ketones as a fuel, it preferentially
uses carbohydrates and requires a minimum level of glucose
circulating in the blood in order to function properly. Before
the adaptation process occurs, sub-optimal hypoglycemic blood
glucose levels typically cause headaches in response to a
the processes of protein degradation and ketosis can create
problems of their own during prolonged fasting, they are adaptive
mechanisms during glucose shortages. The first priority
of metabolism during a prolonged fast is to provide
enough glucose for the brain and other organs that dependent
upon it for energy in order to spare proteins for other cellular
second priority of the body is to shift the use of
fuel from glucose to fatty acids and ketone bodies. From that
point on, ketones significantly become more important as a
source of fuel, while fatty acids and glucose become less
To prevent these ketotic symptoms, it is recommended that
the average person consume at least 50 to 100 g of carbohydrates
per day, and when ingesting dietary protein, include an appropriate
ratio of protein-to-carbs symbiotic to protein synthesis.
CAUSES BODY FAT GAINS & SLOWS METABOLISM
protein and/or low carbohydrate diets slow down metabolism.
During high protein and/or low carbohydrate diets, weight
loss may be realized but the type of weight that is actually
lost includes muscle mass as well
as fat. When muscle mass is reduced in humans in response
to high protein and/or low carbohydrate diets, fat-burning
slows down and metabolic rates decrease. This
results in increased body fat and decreased lean muscle mass.
reduced lean body mass, resting metabolic rates decrease since
skeletal muscle requires more energy at rest and during exercise
than adipose fat tissue. Diets and protein supplements that
contain adequate Low Glycemic carbohydrates not only increase
physical well being, but also contribute to body fat loss
and maintenance of lean muscle mass.
& SPORTS PERFORMANCE
Test Food, Protein-Glycoside-Matrix, was specifically
formulated to provide a Metabolic Advantage to athletes.
One of the components relative to this claim is the Anti-Ketogenic
properties of the Test Food.
athletes, Ketosis has been proven to:
Reduce brain capacity and function
lean muscle mass
is one of the most severe and negative states in protein synthesis
and utilization, brain function, and fat-burning. Some classes
of dietary amino acids are gluconeogenic, meaning glucose
producing, while many amino acids are ketogenic and cannot
enter the citric acid cycle.
the level of ketones in the body rises while levels of glucose
fall, and many organs begin to function less efficiently,
including the brain, which relies heavily on glucose. Proteins
that do not contain carbohydrates exacerbate brain-focus-reduction,
reducing mental focus and sports performance.
an athlete’s performance and career ultimately depend
on fast-brain-response, this athletes cannot afford reduced-sports-performance
due to ketogenic proteins or diets. Neither the athlete nor
the non-athlete can afford reduced-brain-function, or disrupted
protein and fat metabolism.
terms of added body fat and energy-synthesis, fats can only
be metabolized (burned) when there is a adequate
amount of glucose from carbohydrates present to produce oxaloacetate,
which condenses with acetyl CoA in the citric acid cycle.
Since fatty acids are degraded directly to acetyl CoA, they
cannot be used as an energy source, and can be transformed
levels of ketones in the blood stream are dangerous, and low
amounts of glucose (from dietary carbohydrates) in the blood
can be detrimental to the brain and to sports performance.
STORAGE CAPACITY OF PROTEINS
storage capacity of protein in humans has been well established.
Storage capacity relates to the maximum amount of protein
the human body can process without negative consequences.
In World-Class powerlifters, who weigh up to 400 pounds, the
storage capacity of proteins does not exceed 30 grams within
a 2-3 hour period.
World-Class bodybuilders, such as Mr. Universe, who
hold huge amounts of muscle mass, and low amounts of body
fat, regardless of weight or size, or calories burned, or
degree of muscle mass, the 30-gram protein rule does not change.
The average, non-athlete does not require an intake
of 30 grams of protein at one time, and can achieve protein
homeostasis by ingesting specific forms and amounts of elemental
protein throughout the day.
large-size competing athletes, the homeostasis-dose of protein
is 30 elemental grams. The 30-gram protocol should not be
used in non-athletes, as this dose of protein cannot be metabolized
or utilized in the body without benefit of high-muscle mass,
as well as high-energy-output and high-caloric-burning. Using
proteins at the 30-gram dose in an inappropriate ketogenic
formula/product can cause serious medical problems, including
ketosis, elevated liver enzymes, and liver damage.
humans, ingestion of ketogenic proteins and meal replacement
products results in increased body fat levels via elevation
of insulin and LPL fat-storage in adipose tissue
fat cells. Ketogenic protein drinks and meal replacements
protein drinks and products that only contain sugar alcohols,
synthetic sweeteners, and other non-carbohydrate ingredients,
do not achieve health protein storage capacity, and
can cause ketosis and liver problems.
terms of timing, protein drinks should not be consumed near
bedtime, as this causes lowered Delta-stimulated GH and testosterone
OF CORTISOL’s MEDICAL IMPACT
IN HUMAN HEALTH
is a corticosteroid hormone. The synthesis of Cortisol in
the adrenal gland is stimulated by the anterior lobe of the
pituitary gland. The highest levels of Cortisol in humans
occur in early morning, with lowest levels in the evening
and 2-3 hours following the onset of the sleep cycle.
and over-elevation of Cortisol in humans is triggered by a
variety of external biochemical events resulting in mild-to-serious
medical problems, including reduction of sports performance
in athletes, and excess adipose tissue body fat.
down-regulation of Cortisol is an obvious advantage in protein
metabolism, and the Test Food under investigation will provide
substantiation of Cortisol-down-regulation. As of September
2009, no prior substantiated evidence of proteins
that down-regulate Cortisol have been introduced.
Test Food duly submitted to the Glycemic Research Institute®,
Protein-Glycoside-Matrix (PMG), is described as an
advanced protein delivery system, that is undergoing independent
government Certification Human In Vivo Clinical Trials, with
the goal of clinical substantiation of metabolic properties
and legal claims.
proprietary PMG formula was designed to mitigate and/or eliminate
blood glucose and insulin excursions in humans caused by ingestion
of High Glycemic proteins, thus blunting Lipoprotein Lipase
(LPL) fat-storage, adipose tissue fat-storage, body fat weight
gains, and stimulation of fat cell replication.
addition, PMG was designed to replace ketogenic protein supplements,
and meal replacements that activate Cortisol and GLP-1.
Test Food will be recommended in the following human
To achieve protein homeostasis
a protein supplement and/or meal replacement
an adjunct to promote lean muscle mass in active persons
part of a healthy weight management program
professional and non-professional athletes
In catabolic medical conditions
In type 2 diabetics for glucose control
In insulin-resistant individuals
an adjunct to anexoria medical treatment to prevent catabolism