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EZEPRO: A Novel, Patented, Ready-to-Drink Protein For Early Recovery And Shortened Convalescence

Author: Dr. Amit Srivastava

M.S., M.Ch. Sr. Cardio Thoracic Vascular Surgeon Apex Hospital, Varanasi.

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Abstract

In the context of critical illness, evidence suggests that exogenous protein/amino acid supplementation has the potential to favorably impact whole-body protein balance. It has been suggested that exogenous protein should be supplemented in sufficient amounts to mitigate protein loss. It is well established that this breakdown is more pronounced in the early phase of illness which then subsides gradually during recovery. Observational studies have demonstrated that the achievement of >90% of target protein intake in the early phase of illness associated with improved ICU outcomes in mechanically ventilated critically ill patients.

Keywords: EZEPRO, Ready-to-Drink protein, ICU-induced weakness, Critically ill patients

 

Introduction

In three macronutrients, protein is one that the body needs in higher quantities. The other macronutrients are fat and carbohydrates. Proteins are made up of hundreds or thousands of minor units termed amino acids, which are attached to one another in long chains. There are 20 diverse types of amino acids that can be combined to make a protein. The arrangement of amino acids decides each protein’s unique 3-dimensional structure and its exact function.

Proteins are large, complex molecules that play many critical roles in the body. Proteins do most of the work in cells and are vital for the structure, function, and regulation of the body’s tissues and organs.

In every single body cell, protein is present and an ample protein intake is essential for keeping the muscles, bones, and tissues healthy.

 

Consequences of low protein in critically ill patients

Critical illness, a life-threatening multisystem process, can result in significant morbidity or mortality; common complications involve increased infectious morbidity, multi‑organ failure, and prolonged hospitalization [1]. Critical illnesses give rise to severe metabolic stress and the suffering patients often develop systemic inflammation. It causes an increase in muscle proteolysis leading to amino acid catabolism and urea synthesis, which subsequently disrupt the body nitrogen balance and make it strongly negative [2]. If there is deficiency of protein and energy for a long time during illness, it leads to the condition known as protein- energy malnutrition [3] and starvation disease [4]. Protein-energy malnutrition is a prevalent consequence of hospitalization, especially in critically ill patients admitted to the intensive care unit (ICU). It is a global problem with a prevalence 50.8% and 78.1% in developed and developing countries, respectively [5]; the situation is no better in India and the published evidences suggest reported rate ranges from 39% to 50% [6,7,8]. The published evidence also revealed that more than half of all ICU patients are significantly underfed globally which worsens the condition [9]. The prolong malnutrition is associated with adverse clinical outcomes, increased rates of morbidity, mortality, and reduced quality of life with longer hospitalization [10,11]. Economically, protein malnutrition leads to the significant increase in healthcare costs and utilization of resources.

Dramatic alterations are witnessed in protein metabolism with all critically ill patients like alterations in metabolic balance, with catabolic responses being consistently higher than those associated with protein anabolism. The scale of the loss of protein during illness is proportional to the harshness of injury [12]. In its most severe cases, mostly in critical illness, the catabolic response linked with protein loss leads swiftly to the exhaustion of existing protein contained within cells and tissues with the subsequent advancement to protein malnutrition. Severe protein malnutrition is associated with poor clinical outcomes, including severe muscle deconditioning, ventilator dependency, poor wound healing, immune dysfunction, incompetence to maintain activities of daily living, and ultimately death [13]. An inordinately elevated incidence and prevalence of protein malnutrition are observed in hospitals. This poorly recognized condition is also called hospital-acquired or disease- acquired malnutrition. Up to 30% or even more of all patients in hospitals are known to have significant protein malnutrition. Protein malnutrition expressively increases healthcare costs and the utilization of precious healthcare resources. Thus, it is a crucial priority to find solutions that overcome protein malnutrition.

 

Role of protein in speedy recovery of critically ill patients

Protein: a fundamental element of metabolism in seriously ill patients.

In the milieu of critical illness, evidence advocates that exogenous protein/amino acid supplementation has the potential to favorably impact whole body protein balance [14,15].

The American Society for Parenteral and Enteral Nutrition (ASPEN) and the Society of Critical Care Medicine (SCCM) nutrition guidelines recommend 1.2 to 2.0 g/kg/ day [16]. Some experts conclude that up to 2.0–2.5 g/kg/day of protein, and even higher doses in severe burn and trauma patients, is safe and could be considered an ideal dose [17]. Yet existing observational studies document that critically ill patients are being prescribed much less than that, an average of 1.3 g/kg/day, and getting only 55% of what is prescribed on average (approximately 0.7 g/kg/ day) [18].

Numerous physio metabolic deviations occur in critically ill patients. These deviations may increase the risk of malnutrition [19]. A Decrease in total calories and protein intake confuses the deteriorating clinical condition. Rise in sepsis, rise in inflammatory biomarkers, and metabolic imbalance may result in multiple organ failure, shock, and mortality. A Detailed assessment of critically ill patients will help in deciding the strategy of nutritional support and further increase the patient outcomes.

Nutritional support becomes vital to fulfilling the macro-and micro-nutrient necessities in such patients. Route-of-feed administration (enteral or parenteral) needs to be decided based on the calculation of hemodynamic status and gastrointestinal functioning [20]. This will avoid risks linked with faulty feeding methods. Early enteral nutrition (EEN) in the critically ill patients is found to be allied with many benefits and at the same time, with reduced risk of complications. [21] Patient outcomes in the Intensive Care Unit (ICU) are affected by proper timing of initiation, amount and type of nutrition. Initiating feeding within 24–48 h of critical illness is defined as early nutrition intervention.

 

Route of nutrition (enteral vs. parenteral): Preference in critical-care settings

EN is preferably commended over PN as early nutrition in critically ill patients [22]. The route of nutrition delivery governs the effect of the nutritional intervention. Enteral route is more physiologic, providing nutritional benefits without unfavorably disturbing structural–functional integrity of the gut and intestinal microbial diversity. EN has a limitation in the acute disease phase and gastrointestinal dysfunction due to its probable lower nutritional adequacy. In contrast, the intended nutritional requirement is better secured with PN but hyper alimentation, hyperglycemia and infectious complications remain the key challenges [23].

In critically ill patients, supplemental PN at the end of the 1st week after ICU admission is advisable when full EN support is not possible or fails to deliver caloric targets of up to 60% [24].

 

Currently available therapy

Because of worries in tolerating, digesting, absorbing whole protein and need of reconstitution, it is seen that critically ill patients may not be able to attain adequate macronutrient or micronutrient protein requirements through oral powder formulations of protein.

Therefore, in hospitals, a dietary meal with high protein and energy content are given to ICU patients (table 1) [25]. The normal feed for patients comprises of eight feeds of 150-250ml per session at equal breaks of 2hrs. This is not only lumber some, but involves proficiency to make the precise quality and quantity of preferred amount of meal. Additionally, dals and cereals comprise one less vital amino acid in content, which does not help in the making of protein. So the comprehensive meal is essential with tallying of rice or chapatti.

 

Table 1: Foods containing potential amino acid are following [25]

Food

mEq per g of protein

Oatmeal

0.82

Egg

0.8

Walnuts

0.74

Wheat (whole)

0.69

White Rice

0.68

Barley

0.68

Tuna

0.65

Chicken

0.65

Corn

0.61

Milk

0.55

Soy

0.4

Peanuts

0.4

Almonds

0.23

Potato

0.23

 

There are however definite challenges with meals for example egg is a good source of protein, however other components in the egg may not be suitable for critically ill patients. One large egg (50gm) comprises approx. 6gm of protein, 70mg of sodium, 70mg of potassium, 100mg of phosphorus, apart from high calories and carbohydrates [26].

Potential challenges with other meals, especially non-vegetarian include postprandial hypotension and other hemodynamic instabilities, aspiration risk, gastrointestinal symptoms, hygiene issues, staff burden, reduce solute removal, and increased costs. Differing in-center nutrition policies exist within organizations which is a possible challenge for a meal in the critical ill patients.

Patients also resort to oral protein supplements (powders). There are certain challenges with powder supplements as it causes constipation and bloating in the patients, there is a hassle of reconstitution each time as the powder needs to dissolve in a definite volume of liquid, the main problem with reconstitution is that it does not let the right quantity of protein reach the system, proteins in powder forms leads to poor absorption in critical ill patients and they also have electrolytes exceeding the limits prescribed to the patients (lipids, sugars, carbohydrates, sodium, phosphorus and potassium content).

Some oral protein supplement has dairy protein source containing whey and casein. Whey is the quick digesting and fast assimilating protein within a short duration. It provides a rapid source of amino acids and is good for an instant requirement. While casein coagulates in the gastrointestinal tract giving the feeling of satiety. It is a slow assimilating protein providing the sustained release of amino acid in the body within a longer duration. However, the unbalanced formula does not meet the required criteria for critical ill patients.

Additionally, current available products may have high levels of sodium, potassium and phosphates potentially deleterious for the procedure involves in ICU patients. Some protein supplements may contain artificial flavors like maltodextrin and additives like sodium benzoate. Powders requiring reconstitution into semi-liquid food and are not adapted to patients in intensive care, Problems of taste/palatability which causes low compliance.

Moreover, the undissolved or undigested protein lumps of protein not only makes patient feel gut heavy or gut discomfort, but microbes in the colon act on these lumpy undigested protein particles and try breaking them down leading to the formation of fermented metabolites like thiols, phenols, ammonia, indoles and amines which are undesirable substances due to which these patient have tendency to pass foul gas too frequently and experience gastritis, flatulence etc.

Considering the above challenges and while interacting with doctors, it has been established that Ready-to-Drink protein supplement offers the following advantages over other available supplements like:

  • Short and long term benefits of protein supplements in critical ill patients include improvement in the whole body and skeletal muscle protein balance.
  • Ready-to-drink protein supplements can bridge the protein nutrition gap when eating enough food and powder proteins are not feasible.
  • The sole source of protein nutrition for critically ill patients who are at risk of malnutrition, particularly those with high energy and protein requirements and powder protein restrictions.
  • Integral component of diabetes management improved glycemic control and lower diabetic complications.
  • Protein needs are increase during critical ill conditions to support malnutrition and growth and early recovery in critical ill patients.
  • Improving outcomes of chronic disease which require more protein to recover and decreases all-cause mortality, hospitalization rate and increased survival rate.

 

Ezepro, Ready-to-drink Protein Formula for Management of Protein Loss in critically ill patients

Foods have slow-digesting proteins due to which amino acids are not stored but are taken up by the body cells for the synthesis of proteins. Slow digesting protein is absorbed at a rate that doesn’t induce much muscle protein synthesis. To overcome these issues, Alniche has developed a Ready-to-Drink oral protein supplement (Ezepro) for improving the health of critically ill patients due to protein loss.

EZEPRO is the patented, 1st ready- to-drink protein formula, with the right-quantity of slow assimilating high-quality protein with high biological value (BV) and PDCAAS* value equal to 1. This helps in the slow assimilation of protein ensuring near 100% absorption in the body. The highest possible score is One. This score means after digestion of the protein; it provides per unit protein 100% or more of the indispensable amino acid required.

In addition, Ezepro delivers 55.12 Kcal and is low in sodium, potassium and phosphorus; with no added soya and sugar; hence suitable for diabetic patients as well.

Ezepro pack is uniquely designed to ensure stability, patient convenience and most importantly it is an environmental friendly pack. Patient can carry and consume Ezepro anytime, anywhere without anyone’s help. Currently available protein powders in market needs reconstitution and has many problems like:

  • Every time, it is difficult to measure right quantity of powder in scoop. To level the scoop, patient or attendant or nurse touches powder resulting in high chances of contamination that even multiplies with every touch
  • Cleanliness of glass is questionable
  • Pure sterile drinking water is must
  • Chances of powder taking moisture and gets solidify
  • Carrying bulky powder box

 

So, Ezepro is a tailored readymade protein drink for the critically ill patients that prevent rapid loss of muscle mass, ensures energy intake. Ezepro has an optimally balanced formula of the right quality and quantity of 100% assimilated protein suitable to ICU patients suffering from ICU acquired weakness.

 

Conclusion

In conclusion, there is good evidence to support protein in the ICU is beneficial although delivery must be individualized. An upper range of 2.5g/kg/day is considered safe. Optimal protein intake may be different in the acute compared to the prolonged phase of the illness. Due to the heterogeneous nature of the ICU population decisions must be made on an individual basis. Aggressive protein delivery combined with resistance exercise may improve muscle kinetics, metabolism and regeneration.

 

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