NZ720647B2 - Composition and method for control of post-prandial glucose - Google Patents
Composition and method for control of post-prandial glucose Download PDFInfo
- Publication number
- NZ720647B2 NZ720647B2 NZ720647A NZ72064714A NZ720647B2 NZ 720647 B2 NZ720647 B2 NZ 720647B2 NZ 720647 A NZ720647 A NZ 720647A NZ 72064714 A NZ72064714 A NZ 72064714A NZ 720647 B2 NZ720647 B2 NZ 720647B2
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- drink
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- water
- shearbanding
- diabetes
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- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
- A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
Abstract
drink for moderating blood glucose levels produced by a meal in a human subject suffering diabetes or IGT the drink comprising: at least one water soluble or water dispersible material selected from the group consisting of amino acids, peptides and proteins in a total amount of at least 8g on a dry weight basis per serving of drink; aqueous liquid in an amount of from 70ml to 400ml per serving, and fenugreek fibre in an amount in the range of from 1g to 15g. y weight basis per serving of drink; aqueous liquid in an amount of from 70ml to 400ml per serving, and fenugreek fibre in an amount in the range of from 1g to 15g.
Description
Composition and Method for Control of Post-Prandial Glucose
Field
This invention relates to ed drink formulations for use by people with
diabetes or impaired glucose tolerance (IGT) often ed to as pre-diabetes. In
particular the invention relates to functional drinks that are taken in association with
meals or in association with oral medications, and that te post-prandial
glucose levels such as by reducing andial peak blood sugar level, or reducing
postprandial blood sugar area under the curve (AUC) of blood sugar level vs. time.
Embodiments also relate to a method of treatment of diabetes and IGT and a kit for
use in treatment of diabetes and IGT and use of the composition for cture of a
medicament for treatment of diabetes and IGT.
Background
Impaired glucose tolerance (IGT) is a pre-diabetic state of dysglycemia that is
associated with insulin resistance and increased risk of cardiovascular pathology. IGT
may precede type 2 es mellitus by many years. IGT is also a risk factor for
mortality. ing to the criteria of the World Health Organization and the American
Diabetes Association, impaired glucose tolerance is defined as two-hour glucose
levels of 140 to 199 mg per dL (7.8 to 11.0 mmol) on the 75-g oral glucose tolerance
test. A patient is said to be under the condition of IGT when he/she has an
intermediately raised glucose level after 2 hours, but less than would qualify for type 2
diabetes mellitus. The fasting glucose may be either normal or mildly elevated.
Diabetes includes Type 1, Type 2 and Gestational Diabetes.
Type 1 diabetes: results from the body's failure to produce n, and
presently requires the person to inject insulin. (Also referred to as insulin-dependent
diabetes mellitus, IDDM for short, and juvenile diabetes).
Type 2 diabetes: results from insulin resistance, a ion in which cells fail
to use insulin properly, mes combined with an absolute insulin deficiency.
rly referred to as non-insulin-dependent diabetes mellitus, NIDDM for short,
and adult-onset diabetes).
Gestational diabetes: is when pregnant women, who have never had diabetes
before, have a high blood glucose level during pregnancy. It may e
development of type 2 diabetes.
Other forms of diabetes mellitus include congenital diabetes, which is due to
genetic defects of n secretion, cystic fibrosis-related diabetes, steroid diabetes
induced by high doses of glucocorticoids, and several forms of nic diabetes.
Both type 1 and 2 are chronic conditions that usually cannot be cured.
A number of studies have been conducted to examine the effect of diet
supplements, particularly high fibre supplements on control of post-prandial e in
healthy and diabetic subjects.
Our co-pending International Application No (Publication
WO 73874) describes a drink for moderating blood glucose levels produced by
a meal in a human t suffering diabetes or impaired glucose tolerance (IGT) the
drink comprising:
• at least one water soluble or water dispersible material selected from the
group consisting of amino acids, peptides and proteins in a total amount of
at least 8g on a dry weight basis per serving of drink;
• aqueous liquid in an amount of from 70ml to 400ml (preferably in an amount
of from 100 ml to 250 ml and more preferably from 125 ml to 175 ml) per
serving, and
wherein the drink exhibits shearbanding when t to the shearbanding test
therein described. This is referred to henceforth as centric shearbanding.
We have now found that certain aqueous compositions of water soluble or
water dispersible material selected from the group consisting of amino acids, peptides
and proteins and fenugreek fibre provide effective l of randial blood
glucose levels despite the compositions not exhibiting the standard centric
anding according to the standard test described in .
Summary
Accordingly we provide a drink for moderating blood glucose levels produced
by a meal in a human subject ing diabetes or Impaired Glucose Tolerance (IGT)
the drink comprising:
• at least one water soluble or water sible protein selected from the group
consisting of dairy whey and hydrolyses products of dairy whey in an amount of
from 10g to 40g on a dry weight basis per serving of drink;
• s liquid in an amount of from 70ml to 400ml (preferably in an amount of
from 100 ml to 250 ml and more preferably from 125 ml to 175 ml) per serving,
soluble dietary fibre fraction of fenugreek in an amount in the range of from 1g to 15g;
wherein the weight ratio of fenugreek fibre to said water soluble or water dispersible
protein is in the range from 2:20 to 15:20.
It is generally preferred that the eek fiber constitute at least 50%w/w,
preferably at least 80%w/w of the water soluble fibre present in the composition. In
one set of ments the composition does not exhibit centric shearbanding
according to the test described in International Application .
There is also provided a use of a unit or serving of powder in the preparation of
a drink for moderating the blood glucose levels of a subject suffering diabetes or IGT
ed by a meal the unit serving of powder comprising at least one water soluble
or water dispersible protein selected from the group consisting of water soluble or
water dispersible protein selected from dairy whey and hydrolysis products of dairy
whey in an amount of 10 g to 40 g on a dry weight basis of the powder serving and
soluble dietary fibre fraction of fenugreek seed in an amount of from 1 g to 15 g;
wherein the weight ratio of fenugreek fibre to water soluble or water dispersible
protein is from 2:20 to 15:20; and wherein the unit serving of powder is for mixing with
aqueous liquid in an amount of from 70 to 400 grams of aqueous liquid per unit
g to provide a drink which exhibits eccentric anding; and the drink is for
stering to the subject no more than 30 minutes prior to ingestion of the meal.
The unit serving of powder is particularly useful in treatment of ts
suffering diabetes (specifically type 2 diabetes) or impaired glucose tolerance.
Also sed is a kit for providing a serving of a drink for ting blood
glucose levels following a meal the kit comprising:
• at least one serving of water e or water dispersible material selected from
the group consisting of amino acids, peptides and ns in a total amount of
at least 8g on a dry weight basis per serving of drink;
• a container having a level indicating a liquid volume of from 70ml to 400ml;
• a e for the ner; and
• a space within the container above the level to allow vigorous mixing prior to
consumption wherein the mixing of the powder with water filled to the level
provides a drink which exhibits eccentric shearbanding on a standard rotating
er eccentric shearbanding test as herein described.
The kit is particularly suited to control of blood glucose levels in human
subjects suffering diabetes or impaired glucose tolerance (IGT).
The drink and its use may not produce a drink composition which is c
shearbanding and indeed the composition is generally not centric shearbanding under
the test conditions described in .
However we have found that the drinks which exhibit ric shearbanding
under conditions of a eccentric shearbanding test as herein after described are useful
in the control of post-prandial blood glucose, particularly in subjects suffering diabetes
or IGT.
In a further set of embodiments the composition does not exhibit shearbanding
under conditions of the shearbanding test described in (herein
referred to as the centric shearbanding test).
Detailed ption
Fenugreek
Fenugreek fibre refers to the soluble dietary fibre fraction of fenugreek
(Trigonella foenum-graecum) seed. The amount of fenugreek fibre present in a
serving of the drink composition is generally in the range of from 1 g to 15 g,
preferably from 2 g to 11 g, more preferably from 3 g to 8 g, still more preferably from
4 g to 6 g.
The ratio of fenugreek fibre to said water soluble or water sible material
(preferably n) is in a weight ratio in the range of from 2:20 to 15:20, and
preferably in the range of from 3.5:20 to 8:20.
It may be preferred that the fenugreek fibre constitute at least 50%w/w,
preferably at least 80%w/w of the water e fibre present in the composition. In
one set of embodiments the composition does not centric exhibit shearbanding
according to the test described in International Application 2013/000537.
Shearbanding
Shearbanding in a liquid driven by a rotating cylinder is characterised by the
existence of (1) a band or region of high shear proximal to the ng cylinder and
(2) a band region that does not exhibit significant shear. The presence of
shearbanding may be recognised in many cases by the existence of a visually
apparent interface between the bands of vely high shear and band which does
not exhibit significant shear.
Centric shearbanding in a liquid is determined using a drive shaft such as a
rapidly rotating cylinder in the centre of a circular container, and the presence of
shearbanding may be visually observed using a dye drop spaced from the drive shaft.
This is described in detail in the examples section of International Application
Eccentric shearbanding, on the other hand, is determined using a drive shaft
d in an eccentric position near the wall of the container as described in the
es section of this application.
In the presence of thickeners, fibre or the like the composition may gradually
increase in viscosity if formed by mixing a dry powder composition with water. In
such embodiments the determination of the presence of shearbanding is determined
at 10 minutes after the commencement of us mixing of the dry composition with
water. This applies to both centric shearbanding and eccentric shearbanding.
In some instances, liquids may be shearbanding in an eccentric shearbanding
test and non-shearbanding in a centric shearbanding test.
Protein
The water soluble or water dispersible protein is selected from dairy whey and
hydrolysed dairy whey.
It has been found by interrogating consumers that the regular consumption of
high volumes of liquid prior to a meal can cause gastric discomfort when the meal is
eaten. Preferably pre-meal drinks are no more than 300ml in volume and more
preferably no more than 200mls.
The proportion of said water soluble or water dispersible material rably
protein) based on total solid powder is preferably in the range 40 – 90% and more
preferably 50 – 80%.
The water soluble or water dispersible protein is present in an amount of at
least 10g on a dry weight basis per serving, ably at least 15g on a dry weight
basis per serving. The water soluble or water dispersible protein is in the range of
from 10g to 40g, more preferably 15g to 35g on a dry weight basis per g of
drink.
Medication
The drink is particularly suitable for treatment of a subject suffering diabetes or
IGT, when the drink is used as part of the ts IGT or diabetes management with
medications. Examples of such medication include at least one selected from the
group consisting of biguanides (such as min), enzyme inhibitors (such as
angiotensin converting enzyme inhibitors (ACEI) and alpha-glucosidase tors),
Sulfonylureas (such as glyburide, glipizide, glimepiride, tolbutamide, chlorpropamide,
acetohaxamide and tolazamide), meglitinides (such as repaglinide),
thiazolidinediones (such as troglitazone, pioglitazone and rosiglitazone), dipeptidyl
peptidase-4 ) inhibitors (such as sitagliptin and salts thereof, ularly the
phosphate salt) and insulin and insulin analogues (such as lispro). Examples of
es of medications include single compositions containing, or poraneous
use of, biguanidas (particularly metformin) and DPP-4 inhibitors (particularly sitagliptin
such as sitagliptin as the phosphate salt).
The ition may be used for subjects receiving es managment
therapy with combinations of drugs for treatment of a diabetes or IGT. Examples of
such combination therapy include combinations of Sufonyl ureas and metformin,
repaglinide and metformin, lidinediones and metformin and enzyme inhibitors
and metformin.
Timing
The drink may be used for administration at least once daily before a meal or
before two or three meals daily.
Diabetes medications are ntly taken with a meal, and in one preferment,
the drink of the invention is taken a period of time before the consumption of meal and
medication. In a further set of embodiments the the medication is administered prior
to taking the drink. In one embodiment the drink is consumed from 0.5 to 15 minutes
before the meal and medications are consumed more than 15 minuted to one hour or
from more than 15 minutes to one 30 minutes before the meal.
The drink is ably used for administration to a subject suffering diabetes
or IGT no more than 30 minutes prior to ingestion of a meal, preferably no more than
minutes prior to ingestion of a meal. It has been found by interrogating consumers
that having a drink 15 minutes or less prior to a meal is significantly more convenient
than having a drink 30 minutes prior to a meal. The composition is also particularly
effective if consumed within 15 s before consumption of a meal.
It is particularly desirable if the drink maintains a high level of efficacy when
taken at a range of times before the meal (or the meal/medication event), i.e. if the
drink is effective both when taken shortly before a meal (i.e. 0.5 minutes before a
meal) and when taken 15 minutes (or even longer) before a meal. This is because in
ce patients are likely to use the drink at various times before a meal.
Most preferably the drink is consumed in the range of from half a minute to 15
minutes before ingestion of a meal. In the case of drink compositions prepared by
mixing with an aqueous liquid it may be preferred for the drink to be consumed shortly
after mixing. This is particularly the case where the drink undergoes a significant
increase in ity after mixing.
Examples of further functional material which may be used in the composition
include:
• Chlorogenic acid, proposed to be responsible for the reduction in diabetes
risk associated with heavy coffee intake.
• Glucose uptake inhibitors, which slow the absorption of glucose and include
viscosifying agents such as vegetable fibre. Specific examples include
glucomannam, psyllium husk fibre, and guar gum.
• Peptide analogues, such as incretin mimetics, glucagon-like analogues and
agonists, amylin ues.The main ins are glucagon-like peptide-1
(GLP-1) and gastric inhibitory peptide (glucose-dependent notropic
peptide), designated GIP. GLP agonists include Exenatide, Liraglutide and
Taspoglutide. A common side effect (possibly ated with decreased
gastric motility) is nausea.
• Protein hydrolysate, ally with mentation of leucine (US patent
ation 20090305945).
• Alternative medicine and nutritional materials (not sed above). These
include:
o Myrcia root extracts, cialised as pedra hume de kaa.
o Garlic, and particularly deodorised or odour-free garlic
o Cinnamon (Cassia), and cinnamon bark extract
o Curcurmin/turmeric
o ium. Recent testing has shown that magnesium (as magnesium
chloride) shows promise for TYPE 2 DIABETES. Measurement of blood
magnesium can establish the bioavailability of magnesium.
Epedmiological studies show that high daily magnesium intake is
predictive of lower TYPE 2 DIABETES in men and women.
o Zinc
o Coriander
o Eucalyptus
o Red chilli (powdered or fresh)
o Green chilli (powdered or fresh)
o Galangal Powder
o Curry powder
o Ginger
o Shrimp paste
o Seaweed extract
o L-arabinose
o Xylose
o Kidney Bean t (food grade amylase tor)
o Seaweed Exract
o Stevia
o Juniper
o Biotin
o Mulberry including mulberry leaf extract
o Dark chocolate (rich in flavonols)
o Flavanols, a class of class of polyphenolic antioxidant that includes
epichatechin.
o Caiapo, which is derived from the skin of a variety of white sweet potato
(Ipomoea batas). It is commercially available throughout Japan without
prescription for treating type 2 diabetes. Several studies have been
done, some concluding that HbA1c ions are comparable with
Acarbose.
o Bitter melon (Mormordica tia), also known as karela and bitter
gourd, wild cucumber, ampalaya and cundeamor. Glucose lowering has
been documented in animal models of diabetes, and antidiabetic
components e tin and vicine. Several modes of action have
been proposed, including inhibition of glucose absorption in the gut,
stimulation of insulin secretion, and the stimulation of hepatic glycogen
synthesis.
o Gurmar (Gymnema tre). Small studies imply efficacy in type 1
diabetes and type 2 diabetes.
o Prickly pear cactus (Opuntia, . Mainly reported in Spanish
literature. Reported improved glycemic control (lower serum glucose)
and improved insulin sensitivity (decreased serum insulin) following a
single dose (500g broiled or grilled nopal stems) in patients withtype 2
diabetes. No effect in healthy duals.
o Coccinia indica. Double blind, placebo-controlled trial showed significant
ement in glucose tolerance.
o Ginseng (e.g. Ginseng Panax). One study shows 200mg dose
decreases HbA1c by 0.5%.
o Aloe vera. Tests show reduced fasting glucose in type 2 diabetes
patients both in the presence and absence of concomitant sulfonylurea
therapy.
o Traditional e Medicine has identified type 1 es as “wasting
and thirsting syndrome” and type 2 diabetes as “sugar urine illness”.
There are established ents within TCD.
o Lipoic acid (LA) also known as alpha lipoic acid (ALA),
o L-Arginine, which has been classified as a “semi-essential amino
acid”.L-Arginine serves as a direct sor for the thesis of NO
(L-Arginine is acted on by the enzyme nitric oxide synthase). The
evidence appears to be positive for a role in human cardiovascular
health.
o Vitamin D
o Coenzyme Q10. A study on patients with heart disease showed reduced
plasma glucose, insulin and lipid peroxides (the latter a marker of
oxidative stress). Statins (HMG-CoA ase inhibitors, taken by
many type 2 diabetes patients) can reduce serum me Q10 by up
to 40%.
o Polyclonal antibodies – see next section.
Polyclonal Antibodies
o Yaron Ilan et al. (WO 2009113065, filed 2008) “Immuno-modulating
compositions for the treatment of immune-mediated disorders” describe an
anti-insulin antibody for use in an oral therapy to manage symptoms of type
2 diabetes. The antibody is made from bovine colostrum.
o Yaron et al. (WO 2010125565, filed 2009) “Anti-LPS enriched
immunoglobulin preparation for use in treatment and/or prophylaxis of a
pathologic disorder” describe the use of anti-LPS antibodies for use in an
oral therapy to treat ers associated with liver disease (this es
metabolic syndrome and type 2 diabetes).
o Ching-San Lai (US 5747532, filed 1995) “Combinational therapeutic
methods employing nitric oxide gers and compositions useful
ore”, teaches that the oduction of nitric oxide (NO) is
associated with a wide variety of disease states that e diabetes as
well as septic shock, ia, , inflammatory bowel disease,
arthritis, asthma, Alzheimer’s disease, Parkinson’s disease, multiple
sclerosis, cirrhosis, encephalomyelitis, meningitis, pancreatitis, peritonitis,
vasculitis, liver inflammation, renal inflammation, shock, c fatigue
syndrome, burn infection, stroke and cancers. The invention is a method to
treat oduction of NO by using a combination of (a) an agent which
inactivates species that induce NO production and (b) an agent (limited to a
dithiocarbamate-containing agent) that ges NO. A given example of
an agent in category (a) is an anti-endotoxin agent such as an antibody to
endotoxin. The text of the patent discloses oral administration as a
treatment option.
Particularly preferred functional materials include Vitamin D, magnesium,
biotin,cinnamon, caiapo (which is derived from the skin of a variety of white sweet
potato (Ipomoea batas)) garlic, turmeric/curcurmin and anti-lipopolysaccharide
antibody.
The invention will now be described with reference to the following examples.
It is to be tood that the examples are provided by way of illustration of the
invention and that they are in no way limiting to the scope of the invention.
EXAMPLES
Shearbanding test protocol and modified (eccentric) shearbanding test protocol
The specification and claims refer to a measure of shearbanding. The method
for determining shearbanding referred to herein will now be discussed with reference
to the attached drawings.
Brief ption of the drawings
In the drawings:
Figure A is a schematic view an apparatus used to measure ric anding
in accordance with the invention showing the rotating spindle and liquid sample.
Figure B is a view from above of a liquid sample prior to measurement of eccentric
shearbanding with a dye mark placed 20mm from the container wall.
Figure C is a tic view of the apparatus of Figure A during measurement of
eccentric shearbanding.
Figure D is schematic view from above of a measurement of angle Ao referred to in
the Quantitative definition of Eccentric shearbanding.
Figure 1 is a graph of the post-prandial blood sugar measurements of a subject
having ingested a control meal.
Figure 2 is a graph of the post-prandial blood sugar measurements of a subject
having ingested a drink composition of the invention about 15 minutes before the
control meal.
In the Examples the term “WPC80” or “whey protein concentrate 80” refers to
whey protein concentrate having a nominal protein t of 80% w/w of the whey
protein content is in the range of from 76% w/w to 81% w/w of the whey protein
concentrate.
In the Examples “WPI90” or “whey protein isolate 90” refers to whey protein
isolate in which the protein tration is nominally 90% by weight of the whey
protein isolate composition. It will be understood that the trations may vary
slightly such as from 86% to 92% w/w of the composition.
ric Shearbanding Protocol: Objective Measurement of Eccentric
Shearbanding in a Drink
Referring to Figures A to C a quantity of test drink (1) containing 150 mls of
water (e.g. 175 total drink weight g) is well stirred and poured into a circular flatbottomed
container (2) with a base (3) and cylindrical wall (4). The container has a
diameter of 90mm and a wall (4) height of 50mm. The height of the surface (5) drink
(1) in the container (2) is 25mm. A drop of dye (6) is placed on a reference radius (8)
at a point 20mm in from the wall (4) of the ner on a notional line on the surface
of the drink h the centre (7) of the circular container (4). This drop of dye (6)
will be used to define angle A as described below to determine whether eccentric
anding is exhibited by the sample. A smooth wooden er (9) of diameter
12 mm is mounted in a rotatable chuck (10) with the axis of the cylinder (9) vertical,
and the flat base (11) of the cylinder (9) is located above the drink surface. The
cylinder (9) is d at 850 rpm.
The driven-flow aspect of the ement is initiated by lowering the rotating
cylinder (9) into the drink at a distance (9a) 15mm from the cylindrical wall (4) of the
container (2) and at an angle about the centre of the container of 225° (8a) from the
reference radius (8) and position of the dye marker (6). The bottom of the cylinder
(11) is lowered to a depth (13) of 20mm below the drink surface (5). After 90 seconds,
the rotation of the er (9) is arrested, and the cylinder (9) is slowly withdrawn
from the drink.
Quantitative Definition of Eccentric Shearbanding in Terms of Angle A
After driving the drink (1) in the container (2) by lowering the rotating cylinder
(9) for 90 seconds the dye droplet (6) is inspected. The resulting droplet may be
highly elongated with a front edge and a trailing edge in which the leading edge of
inner dye mark (6) has become highly elongated extending through multiple
revolutions about the centre (7). Alternatively the droplet may have relatively minor
elongation (so that the angle subtended at the centre of the ar container is
small). The angle subtended at the centre of the circular container by the front (14)
and a rear edge (15) of the drop is designated angle A (see Figure D). If angle A is
less than 40 then the liquid is considered to exhibit shearbanding behaviour. The
angle A (see Figure D) may be measured by protractor or other suitable angle
measurement apparatus. In the case of the drink of the invention of e 1
(Figure D) the angle A is ined to be 25°. In the case of the drink of
Comparative Example 3 (not in accordance with the invention) the testing produces a
result in which the reference dye droplet (6) is elongated through many revolutions
about the rotating cylinder.
Protocol for determination of eccentric shearbanding interface distances
The eccentric shearbanding test provides an r band region of flow
driven by the eccentric rotating cylinder. Compositions of the invention when subject
to the above described eccentric shearbanding test, exhibit distinct bands or regions
including an inner band or region about the rotating cylinder of vely high shear
(26) and rapid flow and an outer band (27) which does not exhibit significant shear
and which is substantially static when compared with the inner high shear rapid flow
region adjacent the rotating cylinder. In compositions of the invention the outer band
or torroid region which does not exhibit significant shear and which is substantially
static will include the dye drop and produce the eccentric shearbanding result as
before defined (that Angle A is less than 40°).
The interface between the two regions (25) can be readily determined by visual
inspection while the cylinder is being driven during the test period. The distance (28)
of the interface (25) from the rotating cylinder (9) can also be determined during this
period using a ruler.
ric anding testing of drinks prepared from mixing a powder with
aqueous liquid
Many drinks made from reconstituted drink powder have time-variant flow
characteristics. For such drinks, the following standard time sequence should be used
to implement the above s. Step 1 – reconstitute the drink in 150 mls of water
and allow the tituted drink to rest for 7 minutes. Step 2 – stir the rested drink
and pour the drink into the above-described circular flat-bottomed container (2). After
2 minutes apply the dye drops (6) described above to the e (5) of the drink (1),
and lower the rotating cylinder (9) into the drink (1) approx. 15mm from the container
wall as described above.
The above protocol always leads to the formation of a layer of liquid that
manifests local shear immediately proximal to the surface of the rotating cylinder.
In many driven drinks the shearing layer grows radially ds from the
surface of the rotating cylinder and extends hout the liquid (although the
tangential velocity of the driven drink will be significantly slower at positions further
from the rotating cylinder and closer to the wall of the container). However, in drinks
that exhibit eccentric shear band formation (i.e. drinks according to the current
invention), a y static layer of significant thickness (e.g. 3 - 20 mm or even more
measured from the cylinder toward the centre of the container) develops further out
from the cylinder, and this y static outer layer coexists with the shearing inner
layer. The term locally static layer means no shear or comparatively very little shear
is exhibited within said layer. The simultaneous existence of an extensive shearing
band and an extensive locally static band in a steady-state driven flow scenario is the
characteristic feature of eccentric shear band formation.
In more general terms, eccentric shear band formation occurs in a driven-flow
scenario when there is co-existence of (a) an extensive region of drink material that
exhibits no local shear, and (b) an extensive region of drink material that exhibits
icant local shear.
The above ol es a very ive test of eccentric\ shear band
ion because an extensive shearing/rotating band is always found near the
e of the rotating cylinder, and because the shape of the red dye drop is very
sensitive to the existence of local shear. Eccentric shear band formation can be
detected in the above protocol whenever the liquid dye drop substantially maintains
its starting shape (generally ar). In the presence of even small amounts of local
shear, the liquid dye drop becomes significantly elongated in response to the local
shear. This liquid-drop test for local shear is significantly more sensitive than can be
ed by introducing high-contrast solid particles to the drink (as flow markers) –
this is because a solid marker will move according to the resultant forces on the solid
particle, and local shear can be inferred only by comparing one particle of solid
marker with a separate particle of marker.
Shake-and-Take Process for er Use
An elongated container may be used in preparation of drink composition for
consumption by subject. Although the drink may be prepared by mixing as described
in conducting the eccentric shearbanding test, we have found it to be particularly
ient for untrained consumers of the drink to prepare it by a shake-and-take
method.
The shake-and-take method uses a container having a side wall and a flat
bottom wall that is preferably joined to the side wall by a smooth curved transition
portion to avoid recesses in which a deposit of powder may be resistant to being
suspended in added water.
The container is provided with a closure which is close fitting to inhibit leakage
of liquid during shaking. The container and closure may have co-operating threaded
portions to provide sealing.
The container may be of volume such as 200 ml to 600ml ing on the
volume of drink which is generally no more than half the volume of the bottle.
In the shake-and-take process, a powder such as containing the protein and
fenugreek is added to aqueous liquid such as water of volume such as 100 to 250ml
in the container which is generally no more than half full with the aqueous liquid.
The container closure is sealed on the container and the container is
vigorously shaken. It may be shaken vertically, i.e. with the container closure facing
up or down and preferably the longest axis of the container generally vertical.
r, in a further and more red embodiment the container is shaken
with the longest ion of the ner disposed sideways and with a o-side
motion until the powder is well ded (generally from several seconds to 30
seconds (typically 5 to 20 seconds).
Comparative Example 1 and Example 1
Comparative Example 1
The dry ingredients of 20g Whey Protein trate (WPC-80 approximately
80% w/w whey protein) and 5 gram of guar guam were prepared. The dry powder
was added to a “stock bottle” containing 150ml of water. The lid of the stock bottle
was replaced and then the bottle was shaken vigorously for 10 seconds. This drink
was then put through the “eccentric shearbanding test” as described previously.
The centric shearbanding properties of the ition were determined using
the ure bed in International and eccentric
shearbanding properties were determined according to the procedure described
above and the results are reported in Table 1 below.
Example 1
The dry ingredients of 20g whey protein isolate (WPI-90 approximately 90%
Whey Protein) and 5 gram of eek seed fibre were added to a “stock bottle”
containing 150ml of water. The lid of the stock bottle was replaced and then the
bottle was shaken vigorously for 10 seconds. This drink was then put through the
“eccentric anding test” as described previously.
The centric shearbanding properties of the composition were determined using
the procedure described in International and eccentric
shearbanding properties were determined according to the procedure bed
above and the results are reported in Table 1 below.
Table 1
Fenugreek pre- Centric Centric Eccentric Eccentric
meal drink Shearbanding Shearbanding shearbanding shearbanding
angle A Y/N angle A Y/N
Multiple N 20 deg. Y
Revolutions
Guar pre-meal Shearbanding Shearbanding Eccentric Eccentric
drink angle A Y/N shearbanding shearbanding
angle A Y/N
Angle A is 25° Y 20 deg. Y
N N
Psyllium pre- Multiple Multiple
meal drink revolutions revolutions
Example 2 and Comparative Example 2
These examples compare the blood glucose response of a 60 year old
Caucasian male subject usly diagnosed as abetic (i.e. having IGT) whose
condition was managed by diet and exercise.
Comparative Example 2
The subject took a baseline blood glucose reading (t = -15). 12 s later
subject took another baseline blood glucose reading (t = -3). Subject took another
glucose measurement at (t = 0). 10 minutes later (t=10) the subject took a blood
glucose reading then consumed a meal of 4 slices of white bread (approximately 50g
of ble carbohydrate) with 250ml water over a 10 minute period. Immediately
after having consumed the meal (t=15), and every 15 s afterwards for a r
225 minutes, t took a blood glucose g.
The s are shown in Figure 1.
Example 2
The subject took a baseline blood glucose reading (t = -15). 12 minutes later
subject took another baseline blood glucose reading (t = -3). Subject added the dry
ingredients of 20g Whey Protein Isolate (WPC90) and 5g fenugreek to a “shake and
take” ner containing 150ml water Subject then put the lid on the shake and take
container and shook the container vigorously for 7 seconds. The subject then
ed the drink ation as quickly as possible and took another blood
glucose reading (t = 0). 10 minutes later (t=10) the subject took a blood glucose
reading then consumed a meal consisting of 4 slices of white bread (approximately
50g of available carbohydrate) 10 minute period. Immediately after having consumed
the meal (t=15), and every 15 minutes afterwards for a further 225 minutes, subject
took a blood glucose reading. The results are shown in Figure 2.
Conclusion
The graphs on Figures 1 and 2 show the composition of the invention to
provide significant moderation of the post-prandial blood glucose level in a subject
who has been diagnosed as having IGT.
Our co-pending International Application No shows that
diabetic and IGT subjects that consume drinks containing protein and viscosity raising
fibre prior to a meal that do not have centric shearbanding qualities under the
ions of the c shearbanding test do not perform as well as when the same
subject consumed a drink that showed centric shearbanding.
Drinks that show eccentric shearbanding, as described in this patent, can
lower the post-prandial blood glucose when taken prior to a meal in subjects with IGT
or diabetes as effectively as when subjects with IGT or diabetes ed drinks that
showed centric shearbanding qualities prior to a meal.
Eccentric shearbanding drinks heavily rform drinks containing protein
and viscosity raising fibre that do not show centric shearbanding or ric
shearbanding qualities.
Examples 3 to 8
Compositions of Examples 3 to 8 were prepared by combining the drink
formulation components shown in Table 2 and the eccentric shear g properties
were measured in accordance with the standard test referred to above.
The s are also reported in Table 2.
Table 2
Example DRINK FORMULATION ECCENTRIC SHEARBANDING
No. YES/NO
20g WPI (whey protein) Yes
3 8g Fenugreek Fibre
250ml water
20g WPC80 (whey protein) Yes
4 11.5g Fenugreek Fibre
150ml Water
10g WPC80 (whey protein) Yes
5g Fenugreek Fibre
150ml water
20g WPC80 (whey protein) Yes
6 5g eek Fibre
100ml water
20g WPI (whey protein) yes
7 5g Fenugreek Fibre
150ml water
20g WPC80 (whey protein) yes
8 5g fenugreek Fibre
150ml water
The drink formulations described in Table 2 may be used to moderate blood
glucose in subjects with type 2 diabetes or IGT in ance with the invention.
Claims (12)
1. A drink for moderating blood glucose levels produced by a meal in a human subject suffering diabetes or Impaired Glucose Tolerance (IGT) the drink comprising: • water soluble or water dispersible protein selected from the group consisting of dairy whey and hydrolysis ts of dairy whey in an amount of from 10g to 40g on a dry weight basis per serving of drink; • aqueous liquid in an amount of from 70ml to 400ml per serving, and • soluble dietary fibre fraction of fenugreek seed in an amount in the range of from 1g to 15g; wherein the weight ratio of fenugreek fibre to said water e or water dispersible n is in the range from 2:20 to 15:20, wherein the drink exhibits eccentric shearbanding.
2. A drink according to claim 1, n the weight ratio of fenugreek fibre to said water e or water dispersible protein is in the range of from 3.5:20 to 8:20.
3. A drink ing to claim 1, wherein the drink is to be taken no more than 30 minutes prior to ingestion of the meal.
4. A drink according to any one of the previous claims, wherein the drink is to be taken by a subject suffering diabetes or IGT in association with oral diabetes medication comprising at least one selected from the group consisting of biguanides (such as metformin), enzyme tors (such as angiotensin converting enzyme inhibitors (ACEI) and glucosidase inhibitors), Sulfonylureas (such as glyburide, glipizide, glimepiride, tolbutamide, chlorpropamide, acetohaxamide and tolazamide), meglitinides (such as repaglinide), thiazolidinediones (such as troglitazone, pioglitazone and rosiglitazone), DPP-4 tors (such as sitagliptin and salts thereof, particularly the phosphate salt) and insulin and insulin analogues (such as lispro).
5. A drink according to claim 4 wherein the drink is to be taken 0.5 – 15 minutes before the meal, and the medications are taken with the meal or prior to taking the pre-meal drink.
6. A drink according to any one of the previous claims wherein fenugreek fibre constitutes at least 80% w/w of the water soluble fibre present in the composition.
7. A drink according to any one of the previous claims which does not exhibit c shearbanding.
8. A use of a unit or serving of powder in the preparation of a drink for moderating the blood glucose levels of a subject suffering diabetes or IGT produced by a meal the unit serving of powder comprising at least one water soluble or water sible protein selected from the group consisting of water soluble or water dispersible n ed from dairy whey and hydrolysis products of dairy whey in an amount of 10 g to 40 g on a dry weight basis of the powder serving and soluble dietary fibre fraction of fenugreek seed in an amount of from 1 g to 15 g; wherein the weight ratio of fenugreek fibre to water soluble or water dispersible protein is from 2:20 to 15:20; and wherein the unit serving of powder is for mixing with aqueous liquid in an amount of from 70 to 400 grams of aqueous liquid per unit serving to e a drink which exhibits eccentric shearbanding; and the drink is for administering to the subject no more than 30 s prior to ingestion of the meal.
9. A use according to claim 8, wherein the weight ratio of fenugreek fibre to said water soluble of water dispersible protein is in the range of from 3.5:20 to 8:20.
10. A use according to claim 8 or claim 9, wherein the water soluble or water sible protein is dairy whey.
11. A use according to any one of claims 8 to 10, wherein the drink is for administering to the subject no more than 15 minutes prior to ingestion of the meal.
12. A use ing to any one of claims 8 to 11 wherein the drink is for administering to the subject suffering diabetes or IGT within 5 minutes of commencement of mixing of the powder and aqueous liquid.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2013904469 | 2013-11-19 | ||
AU2013904469A AU2013904469A0 (en) | 2013-11-19 | Composition and Method for Control of Post-Prandial Glucose | |
PCT/AU2014/001064 WO2015074102A1 (en) | 2013-11-19 | 2014-11-19 | Composition and method for control of post-prandial glucose |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ720647A NZ720647A (en) | 2021-03-26 |
NZ720647B2 true NZ720647B2 (en) | 2021-06-29 |
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