Diamax: formulated for diabetic parients - Prodiet

Rua General Potiguara, 1428- CIC Curitiba-PR ZIP: 81050-500 Brazil

A SPECIAL METABOLIC SITUATION
DIABETES MELLITUS.
Prodiet
Specialized liquid formula, for oral or tube feeding
Diamax®
Formulated for glycemic control and prevention of diabetes
complications.
Food through cannula or orally
Free from sacarose, lactose and gluten
Source of nutritional fibers:
65% soluble and 35% unsoluble
Provides 1.0 cal/ml
Liquid volume: 200 ml
Shake before using
Made in Brazil
Flavor identical to Natural Vanilla
Use under guidance of nutritionist and/or
physician.
Exclusive use for Enteral Nutrition.
Forbidden use by Parenteral route.

PROGNOSTICS
Despite major advances in establishing diagnostic criteria of diabetes mellitus (DM) and
knowledge of new treatment strategies, its incidence continues to increase in epidemic
form. According to the International Diabetes Federation (IDF) it is considered one of the
biggest causes of premature deaths in the world, due to associated complications1
.
Insulin deficiency/ineffectiveness causes changed metabolic responses that, when not
balanced, are followed by symptoms that can lead to coma and death2
.
Acute and chronic complications are already well established in their relationship with
increased morbidity and mortality, as well as their prevention by improving the quality of
life of diabetic patients, a fator highly influenced by nutritional care, because it is directly
related to the exacerbation of such complications, and also because it is a consequence
of the latter.

NUTRITIONAL CHANGES
There is a high incidence among diabetic patients, regardless of their predisease
nutritional condition, of the caloric-protein malnutrition and that, if not detected early and
properly treated, make them more susceptible to acute and chronic complications
because it also make metabolic control more difficult2
.
The most frequent causes are:
• Gastroparesis, causing nausea and vomit, eructation, abdominal
bloating, reduction of caloric intake and weight loss;
• Episodes of diarrhea and constipation due to changes in the intestinal
mucous;
• Metabolic changes inherent to the disease, causing a catabolic response;
• Presence of infection and inflammation resulting from such changes,
interfering negatively on the appetite and absorption of nutrients;
• Restrictive diet;
• Emotional factors (depression, social isolation, anxiety, rebellion / denial
of the disease).
METABOLIC CHANGES
Uncontrolled Glucose
The ingestion of a diet with a high glycemic index, for prolonged periods, contributes to
an exhaustion of pancreatic beta cells,resulting in intolerance to glucose3,4
and increased
production of free fatty acids circulating in the postprandial5 period due to reactive
hypoglycemia mediated by increased counter-regulatory hormones for insulin 6.
Therefore, maintenance of plasma glucose, after the metabolization of the ingested
nutrients, that is, of the GLYCEMIC INDEX, is crucial for a good glycemic control being

regulated by factors of the very individual and factors of the diet, such as: type, amount
and retarding effect of the absorption of carbohydrates, lipids, type and amount of
protein, the presence of fibers, etc.3,7
.
DYSLIPIDEMIA
Cardiovascular complications are the major cause of reduction in the survival of
diabetic patients who, in turn, have on dyslipidemia the main risk factor. A proposed
mechanism is the relationship between chronic - degenerative diseases such as DM and
dyslipidemia with endothelial dysfunctions. Such dysfunction refers to imbalance in
endothelial production of mediators that regulate vascular tonus, platelet aggregation,
coagulation and fibrinolysis, highly aterogenic factors, stimulated by the formation of
metabolic products derived from lipids, hormones and cytokines8
.
INSULIN RESISTANCE
The Insulin Resistance (IR) has also been strongly associated with endothelial
dysfunction. Among the lesser-known metabolic functions of insulin is the stimulation of
endothelial nitric oxide production by promoting vasodilation action and activation of two
pathways: Phosphatidylinositol 3- kinase, essential for the uptake of glucose into target
insulin-dependent tissues, such as heart, skeletal muscle and adipose tissue and also
for the regulation of endothelial nitric oxide production. The path of mitogen activated
protein kinase (MAPK) mediates cell growth and migration capacity of endothelial cells
of vascular smooth muscle and monocytes, and expression of prothrombotic and
profibrotic factors. Therefore, dysfunctions in these pathways result in damages to the
endothelial function, reduction in the glucose uptake and aterogenic potential8
.
INCREASED INFLAMMATORY RESPONSE
Studies have also shown that DM type 2 is an inflammatory condition haracterized by
high concentrations of cytokines in acute phase plasma, such as IL-6 and TNF-a,
suggesting linking between this condition, insulin resistance and ndothelial dysfunction

with the beginning of aterogenic process in these patients, in addition to making more
susceptible to infections8
.
A SPECIALIST TREATMENT:
Special situations deserve special treatments, especially when the objective is to
promote the maintenance and/or recovery of the nutritional condition, a factor likely to
compromise in diabetic patients. The advantages of a specialized intervention with a
nutritional approach for patients with diabetes mellitus are well established by the
reference entities at worldwide level on the theme9,10
:
• Maintenance / recovery of adequate nutritional condition;
• Improvement of the immune function;
• Reduced rates of inflammation and infection;
• Improvement of intestinal barrier function;
• Better glycemic and fat control;
• Lower incidence of associated complications.
Considering that chronic degenerative diseases such as DM, may result from a long
period of imbalance not only of energy, but of all the macronutrients of the diet3, the
"Technical Review of Nutrition Recommendations for Diabetic Patients at Health Care
Centers", drafted in the U.S.A., supports an oral nutritional plan focused on the control
of the level of blood glucose and on the retard or reversion of oxidative damages. Finally,
the cost/effectiveness of the early onset of such a therapy11,12
is already assured.
There are also studies that show expenses generated directly (outpatient clinic and
hospital interventions) and indirectly (disability, absenteeism and increased early
retirements due to cardiovascular complications, amputations, vision loss, kidney failure),
which cause economic impact on public treasury, with proportional severity to the health
policies existing in each country13
.

THE CHALLENGE
A NEW PROPOSAL
CONTROL OF THE GLYCEMIC RATE
We performed a meta-analysis of 14 screenings in 356 patients with duration of 10
weeks, randomized and controlled to verify the benefits in the use of diets with low
glycemic rate X diets with high glycemic rate in the control of diabetes types 1 and 2.
Diets with low glycemic rate reduced glycated hemoglobin and frutosamine, as well as
postprandial glucose15,16
.
The same author also found, in another study, an average increase of 3% in fraction
HDL-cholesterol, reduction of 8.5% in fraction LDL and mean reduction of 6% in
triglyceride levels doing the same comparison, thus concluding that diets of low glycemic
rate are clinically useful in glycemic and fat control, preventing the installation of
frequently associated complications17
.
Diamax® provides a different combination of nutrients, resulting in low glycemic
rate and lower risks associated to complications:

The recognition of metabolic problems related to the use of standard diets in
hyperglycemic patients encouraged the investigation of specialized enteral formulas,
assisting the international dietary guidelines to recommend the change in the percentage
of lipids and glycines in the diet, reducing the amount of carbohydrates and
substituting these calories for lipids and proteins in order to maintain adequate
glycemic levels, resulting in reduction of acute and chronic complications while keeping
sufficient caloric density to maintain body weight, one of the goals of the treatment.
Such a diet must have as objective to provide balanced calories and nutrients in order
to improve metabolic results in the patient. ADA recommendations for macronutrients
and met by Diamax ® are the following9
.
• Low calorie consumption;
• High monounsaturated fatty acids diet
• Fibers: 14 grams in 1000 calories.
Several studies using hyperlipidemic diets rich in MUFA for type 2 diabetic patients have
demonstrated a lower insulin requirement and improved insulin sensitivity and lower

levels of: plasma glucose and postprandial glucagon and glycosuria, when compared to
high carbohydrate diets, suggesting that partial substitution of carbohydrates by MUFA
in the supplementation of enteral diet orally improves glycemic control in these patients10.
Maltodextrin from tapioca has its contribution in achieving this objective by having a
slower absorption, a factor responsible for the reduction of postprandial insulin release,
by suppressing the levels of circulating free fatty acids and counter-regulatory hormones,
keeping a low concentration of blood glucose. This digestion/absorption retarded process
promotes a prolonged stimulation of intestinal receptors of nutrients resulting in an also
prolonged feedback, through signals sent to the satiety center in the brain by
cholecystokinin and glucagon-1 peptide, becoming na important co-factor in the
maintenance of the optimum body weight3.
Dietary fibers, particularly soluble, already have their recognized role in glycemic control
both in literature and in clinical practice, and should be established in these patients’
nutritional plan. There is consensus among Canadian, European, American, South
African, Japanese and Indian communities that daily consumption of diets with high fiber
content affects insulin requirements and sensitivity to insulin and, therefore, provided
evidence-based recommendation for nutritional therapy of diabetic patients as a diet rich
in fibers that provides from 15g/1000Kcal, amount offered by Diamax®18
.
Diamax ® innovates at its source of soluble fiber - Polydextrose - which is a polymer
chain of low digestibility glucose capable of producing physiological effects similar to
those of soluble dietary fibers due to their ability to reach the intestines (colon) intact,
suffering no digestion in the upper gastrointestinal tract, both due to the stomach acidity
and to the digestive enzymes. Its low glycemic rate5,-7, compared to glucose (100),
warrants better glycemic control19
.
Animal study comparing the use of diets with a high content of fiber X low fiber content
diets, showed an increase of intestinal villus in the group fed with a diet rich in fibers,
improving significantly the production of glucose carrier of glucose and capacity of jejunal
transportation. Another effect observed was in stimulation in the intestinal production of
the hormone GLP-1, considered a powerful antidiabetic hormone because it stimulates
insulin secretion, inhibits glucagon secretion and slows gastric emptying, playing an
important role in maintaining glycemic homeostasis10
.

Studies involving individuals with DM types 1 and 2 confirm that the Sucralose does not
affect the plasma plasma of glucose and insulin because it is not recognized by the body
as a carbohydrate, and does not undergo metabolization. The safety of its use is assured
by the FDA, which established the Assured Daily Intake (ADI) at 5mg/Kg/day 21,22
.
LIPIDEMIC CONTROL
Due to the fact that cardiovascular disease is the major cause of morbidity and mortality
among diabetic patients, improved lipid profile provided by diets rich in MUFA, in
compliance with the recommendation of the ADA, is of particular importance for patients
undergoing nutritional10
support, considering that saturated fat is the major factor
determining the LDL particle in plasma and diabetic people are more susceptible to
increased cholesterol23
. A study performed by Strychar, comparing the effects of an high
fat diet rich in MUFA, containing from 43 to 46% of carbohydrates and 37 to 40% of lipids
compared to a standard diet containing 54 - 57% of carbohydrates and 27 – 30 % of
lipids, conformed that the high fat diet presents a favorable effect in the lipoprotein
profile of the diabetic patients increasing levels of HDL and reducing LDL10
.
Study carried out in order to determine the effects effects of different types of fibers on lipid
metabolism of rats, using insoluble fiber in the group control and Polydextrose and another

soluble fiber in the other groups, found that the group supplemented with Polydextrose, the
soluble fiber source of Diamax®, presented lower plasma levels of triglycerides and cholesterol
and increased fecal excretion of the latter24.
The increased inflammatory response may become a pathogenic mechanism for organ
dysfunction, thus becoming a determining fator for morbidity and mortality.
Diamax® provides a modulation of this response because of its proper ratio W6:W3 of
5,6:1, since the fatty acids of type omega-3, are characterized as suppressors of the
functions of macrophages and secretion of interleukins, TNF and leucotrienes, among
others. Since fatty acids type omega-6 are characterized as stimulators of the production
of lymphocytes in response to specific antigenic stimulation25
.
AMOUNT AND PROTEIN SOURCE
Pieces of work recognized by the international community recommend the substitution
of part of the protein from animal source to the protein isolated from soy.
Stephenson, in his clinical research, noted that animal protein promotes glomerular
vasodilation by promoting hyperfiltration, speeding installation of diabetic nephropathy in
patients with Diabetes Mellitus type 1, and when substituting by soy protein there was a
reduction of this hyperfiltration, delaying/preventing this complication. Teixeira and
colleagues documented the reduction of Albumina in patients with type 2 Diabetes after
the partial replacement of animal protein for soy protein beingshown the effect of “kidney
protection” in all stages of kidney function.

Studies also show other benefits provided by soy protein to the body of the diabeticpatient
such as improvement of plasma lipids, homocysteine /oxidation reduction of LDL,
reducing the risk of developing cardiovascular complications18
, in addition to ensuring
the supply of all the essential a.a., meeting the recommendations of FAO/WHO.
PRESENCE OF L-CARNITINE
Added by L-carnitine, an ingredient that is part of a complex enzyme, carnitine
acyltransferase I, primarily responsible for the transport of long chain fatty acids into the
mitochondrial membrane to suffer the process of ß-oxidation26
. Among the several
metabolic consequences of hyperglycemia is the formation of malonil-CoA, an
intermediary of glucose oxidation strongly inhibiting the transport of fatty acids inside the
mitochondrion, resulting in reduction of fat oxidation. There is also decreased in mRNA
of carnitine palmitoyltransferase (CTP-1) in the liver, an enzyme that regulates the inflow
of long-chain fatty acids for ß-oxidation3. Based on these changes, it has been proposed
that the supplementation of carnitine improves fat oxidation, saving endogenous
carbohydrate26
.
PALATABILITY
As important as planning a specialized nutritional therapy by the professional, is the
adherence by the patient, and thinking about it, SUCRALOSE, innovative sweetener
used in Diamax®, combines, among other things, excellent palatability to zero
glycemic index.
INDICATIONS
Diabetes Mellitus Type 1 and Type 2, Glucose Intolerance, Gestational Diabetes,
Hyperglycemia by Stress.

Bibliographic References:
1. International Diabetes Federation. Diabetes Atlas. 2006 [cited.
2. Waitzberg DL, Insuficiência Pancreática - Diabetes Mellitus, in Nutrição Oral,
Enteral e Parenteral na Prática Clínica, Atheneu, Editor. 2000, 3a: São Paulo. p.
1229-1241.
3. Volp ACP and Bressan JRM, Bases fisiológicas para o índice glicêmico e suas
diferentes aplicações clínicas. Revista Brasileira de Nutrição Clinica, 2005. 20(2):
p. 83-89.
4. World Health Organization, Report of a Joint FAO/WHO Expert Consultation:
Diet, nutrition and the prevention of chronic diseases. 2003: Geneva. p. 916: I333.
5. Jenkins DJA, et al., Glycemic index: overview of implications in health and
disease. Am J Clin Nutr, 2002. 76: p. 266S-273S.
6. Jenkins DJA, et al., Metabolic effects of reducing rate of glucose ingestion by
single bolus versus continuous sipping. Diabetes, 1990. 39: p. 775-781.
7. American Diabetes Association, Position Statement - Nutrition Principles and
Recommendations in Diabetes. Diabetes Care, 2004. 27(90001): p. 36S
8. Carvalho MHC, Colaço AL, and Fortes ZB, Citocinas, disfunção endotelial e
resistência à insulina. Arq Bras Endocrinol Metab, 2006. 50(2).
9. American Diabetes Association. Standards of Medical Care in Diabetes - 2015.
Diabetes Care, 2015. 38(Suppl. 1):S1–S2 |
10. Vidal AGT, et al., Dietas hipoglicídicas, hiperlipídicas, ricas em ácidos graxos
monoinsaturados em pacientes diabéticos: devem ser prescritas? Revista
Brasileira de Nutrição Clinica, 2005. 20(2): p. 90-94.
11. American Diabetes Association, Nutrition recommendations and principles for
people with diabetes mellitus. Diabetes Care, 1998. 21(1S): p. S32-S35.
12. American Diabetes Association, Position Statement - Diabetes Nutrition
Recommendations for Health Care Institutions. Diabetes Care, 2004. 27(90001):
p. 55S-.
13. Bahia L. Os custos do diabetes mellitus. 2006 [cited.
14. Pimazoni NA, Adaptação: Implicações do nível de controle do diabetes sobre o
grau de risco e a permanência hospitalar, in Grupemef. 2001.
15. Brand-Miller J, et al., Low-glycemic index diets in the management of diabetes: a
metaanalysis of randomized controlled trials. Diabetes Care, 2003. 26(8): p.2261-
2267.

16. Brand-Miller J and Foster-Poeel K, Diets with low glycemic index: from teory to
practice. Nutr. Today, 1999. 34(2): p. 64-72.
17. Brand-Miller J, Glycemic index: scientific merit and utility for research and clinical
practice. Presented American Diabetes Association, 2002: p. 6-15.
18. Anderson JW, et al., Carbohydrate and fiber recommendations for individuals
with diabetes: a quantitative assessment and meta-analysis of the evidence. J
Am Coll Nutr, 2004. 23: p.5-17.
19. Danisco Brochure, LitesseR. The sustained prebiotic for digestive health.
20. Massimino SP, et al., Fermentable dietary fiber increases GLP-1 secretion and
improves glucose homeostasis despite intestinal glucose transport capacity in
health dogs. American Society for Nutritional Sciences, 1998: p. 1786-1793.
21. Sucralose Estudy E 171: A Three month study of the effect of Sucralose versus
placebo on glucose homeostasis in subjects with non-insulin dependent diabetes
mellitus, submitted to the Food and Drug Administration. 1998.
22. Mezitis NH, et al., Glycemic effect of a single high oral dose of the novel
sweetener sucralose in patients with diabetes. Diabetes Care, 1996. 19(9): p.
1004-1005.
23. American Diabetes Association, Position Statement - Evidence-based nutrition
principles and recommendations for the treatment and prevention of diabetes and
related complications. Diabetes Care, 2003. 26(1): p. S1-S11.
24. Choe M, et al., Effects of polydextrose and hydrolysed guar gum on lipid
metabolism of normal rats with different levels of dietary fat. Korean J Nutr, 1992.
25: p. 211-220.
25. Waitzberg DL, Imunonutrição, in Nutrição Oral, Enteral e Parenteral na Prática
Clínica,Atheneu, Editor. 2000, 3a: São Paulo. p. 1516-1518.
26. Sukala WR. L-Carnitine - Review of Scientific Evidence.cited.

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