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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