Clinical Observational Study

Clinic of Endocrinology and Metabolic Diseases

for Treatment of Metabolic Disorders

University Hospital “Queen Giovanna – ISUL”,

Medical University – Sofia 

Nuprovia Ltd

MULTI–COMPONENT FORMULATED FOOD VEGAPLUS

IN CHRONIC MALNUTRITION TREATMENT

CLINICAL OBSERVATIONAL STUDY

Daniela Popova¹, Ivan Timev¹, Srebrina Sidova¹, Venislava Vladimirova¹,
Ognyan Ivanov²

¹Clinic of endocrinology and metabolic diseases for treatment of metabolic disorders, University hospital “Queen Giovanna – ISUL”, Medical University – Sofia

²Nuprovia

ABSTRACT: Malnutrition is a state of insufficient energy and nutrient intake, leading to rapid weight loss and organ dysfunction. It remains a significant problem in modern clinical practice, affecting 30 to 80% of hospitalized patients in Europe. Protein deficiency in particular has a negative effect on all phases of the healing process. The aim of the clinical observation study is to evaluate the effect of a multi-component formulated food Vegaplus with 37% protein content and 29 prescription ingredients in patients with chronic malnutrition. It was administered as a liquid nutritive supplement drink at a dose of 18 g (2 measuring spoons) daily to a standard hyper energy diet for a period of 2 months in a group of 26 patients, 17 women and 9 men with chronic malnutrition (anorexia nervosa, postoperative and oncological malnutrition) for a period of two months. Clinical, physical, anthropometric and serum parameters were monitored before and after the dietary treatment. Significantly ameliorated anthropometric and serum indices and a reduced risk of malnutrition have been established with a good profile, and tolerance without side effects. Vegaplus is an effective supplementation in chronic malnutrition and can be recommended for nutritional support in clinical practice.

Keywords: malnutrition, multicomponent formulated food, protein supplementation, nutritional support

Malnutrition is a state of inadequate energy and nutrient intake, leading to rapid weight loss and changes in organ functions. From 30 to 80% of hospitalized patients in Europe suffer from malnutrition. The causes of malnutrition in the chronically ill people are diverse and interrelated. The most common are psychogenic and/or somatic reduced food intake, malabsorption and maldigestion due to inflammatory, degenerative, postoperative and post-resection disorders of the gastrointestinal tract, increased nutritional and energy needs and increased nutritional and energy losses (6). Adequate dietary protein intake is particularly important. Factors that contribute to low protein intake include physiological changes, disease, mental and physical deficiencies, socioeconomic factors, and genetic predisposition. Factors that require increased protein intake include disease-related protein catabolism, anabolic resistance, low postprandial amino acid levels, decreased muscle perfusion, and sarcopenia (5,12).

Materials and Methods

Vegaplus is a new original multi-component nutritional powder composition of 29 recipe ingredients, intended for the preparation of a protein drink with stevia sweetener, enriched with vitamins and minerals (1). The product Nutritional value is presented in Table 1.

Vegaplus contains 37% plant-based proteins from protein-rich sources: hemp seeds, rice protein isolate with 80% protein content, chlorella. In addition, its composition includes 13% polysaccharides, 6.5% vegetable fats, micronutrients, biologically active substances. Among the ingredients of Vegaplus are barley grass juice powder, which enriches with antioxidants, B vitamins, macro and microelements, amino acids – lysine, taurine, creatine. Carob is also present, which gives a high fiber content and a pleasant chocolate taste without the presence of caffeine. Ceylon cinnamon is added, which has antimicrobial and antidiabetic properties. The nutritional value is high due to the presence of many important micronutrients – water-soluble vitamins – vitamin C, B1, B2, B3, B5, B6, B12; fat-soluble vitamins – vitamin A, vitamin D, vitamin E; minerals – calcium, magnesium, zinc. Natural additives are also added – as a sweetener steviol glycosides, as a flavoring defatted cocoa powder, thickener is guar gum, emulsifier is sunflower lecithin. There are no adverse nutrients such as GMOs and trans-fatty acids. Based on a rich nutritional and multivitamin-polymineral formula, Vegaplus enriches the usual diet and optimizes nutritional imbalances by providing very good protein supplementation without increasing overall energy. This newly formulated food is effective in increasing the body’s antioxidant defences and improving immune resistance. It has potential to activate macronutrient metabolism, regulate blood formation and support bone structure and joint-muscle functions. Based on its low energy content (under 30 calories per measuring spoon) and rich polynutrient composition, Vegaplus can support low-energy dietary regimens.

Table 1

* NRV – nutrient reference value (adults)
Reference intake of an average adult (8 400 kJ/2 000 kcal)
** No recommendation available

In the Clinic of endocrinology and metabolic diseases for treatment of metabolic disorders, a clinical observational study of the use of Vegaplus was conducted in a group of 26 patients (17 women aged 27 to 69 and 9 men aged 30 to 65) with chronic malnutrition, 15 of whom had disordered eating behavior and 11 had postoperative and/or onco-malnutrition. All of them took formulated food Vegaplus in the form of a 250 ml drink with two measuring spoons, delivering 6.7 g of protein once a day as a protein vitamin-mineral supplementation to a standard strengthening diet for a period of 2 months. Observed parameters are physical status, anthropometric indicators – body mass in kg, BMI in kg/m²; hematological indicators – standard complete blood count, hemoglobin; biochemical serum indicators – total protein, albumin, electrolytes; lipid profile, creatinine, liver transaminases, serum iron, blood sugar. The design of the observation includes two blood tests in the clinical laboratory of the University Hospital “Queen Giovanna -ISUL” using standard methods, as well as a clinical examination and anthropometric measurements – initial upon inclusion and control ones after 2 months upon re-hospitalization.

Results

The application of nutritional supplementation with the new formulated food has been implemented without adverse side effects and with good tolerance by all patients. Improved appetite and enhanced eating has been reported. After two months of taking Vegaplus have been found significant improvements in the nutritional status of the patients, their general physical condition and vitality. Anthropometric indicators have also been significantly improved, both in men and women. An increase in body mass has been reported in men by 26.18% and in women by 30.57% (Chart 1).

BMI tracking shows an increase in BMI in men by 14.54% and in women by 10.44% (Chart 2).

The protein supplementation has contributed to the increase in muscle mass and total body mass. Monitoring of blood hematological and biochemical parameters has not shown significant deviations in serum lipids, total protein, albumin, electrolytes, liver and kidney function.

An increase in the number of lymphocytes in the peripheral blood by 22.58% has been found which is a sign of improved nutritional status (Chart 3).

Discussion

The analysis of the new formulated food shows the presence of a wide range of important essential micronutrients in combination with mainly proteins as well as optimal amounts of polysaccharides and vegetable fats, which determines its potential for effective supplementation in conditions of malnutrition. The causes of malnutrition in chronically ill people are diverse and interrelated. The treatment of the underlying disease (drug therapy, surgical, radiological) often has side effects (dysphagia, mucositis, vomiting, diarrhea, lack of appetite) and leads to undernutrition, weight loss, cachexia. The risk group of patients includes those with undernutrition, overnutrition – obesity increases the risk of hospitalization and mortality from influenza infection and inhibits the virus-specific CD8 + T-cell immune response, polymorbid patients, geriatric patients (13,14). The recommendations of ESPEN (The European Society for Clinical Nutrition and Metabolism) require daily 27 kcal/kg body weight energy intake and protein intake of 1.0-1.2 g/kg for polymorbid patients over the age of 65 and 30 kcal/kg body weight energy intake and protein intake of 1.3-1.5 g/kg for severely underweight (15). Adequate protein reserves modulate inflammation, improve immune function, response to disease/trauma, and treatment outcomes. Protein deficiency can affect all phases of recovery, leads to prolonged inflammation, delayed recovery, and a greater risk of infection. Protein is necessary for maintaining and restoring a stable body mass. It is well known that the necessary increased dietary protein intake in conditions of malnutrition is difficult to achieve in practice. Standard nutritional formulas are not able to meet these requirements – when maintaining the calorie intake, the protein dose cannot be reached and there is a risk of hypoproteinemia, and when reaching a targeted increased protein intake there is a risk of overnutrition (2,3,8). Oral nutritional supplements should be used whenever dietary recommendations and food fortification alone are not sufficient to increase nutritional intake to amounts ensuring nutritional goals achievement, and they should provide at least 30 g or more of protein per day for at least one month (7,9,11,16).

In this regard, specialized formulated foods are the most appropriate therapeutic solution for establishing an adequate dietary regimen and overcoming malnutrition (4,10). The multi-component composition and multiple nutrients of the new Vegaplus food ensure coverage of the increased nutritional needs in order to improve metabolism and support the recovery process.

Conclusions

Taking Vegaplus in the form of a drink prepared from two measuring spoons (18 g) in a glass of water daily for a period of 2 months leads to a significant improvement in nutritional status and has a pronounced supplemental effect in chronic malnutrition. Significantly improved anthropometric and blood parameters and a significantly reduced risk of malnutrition have been established. Diet therapy with the formulated food Vegaplus shows a good safety and tolerance profile. The results of the clinical observation conducted in patients with chronic malnutrition prove that Vegaplus is an effective supplementation in malnutrition and can be recommended for nutritional support in clinical practice.

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Correspondence address: Assos. Prof. Dr. Daniela Popova, Sofia, Bulgaria, ul. “Byalo more” 8, UMBAL „Tsaritsa Ioanna-ISUL“, CEMDTMD; danielapopovabg@yahoo.com