Provision of Local Food-Based Formula Using Pila Ampullacea , Tempeh, and Moringa Oleifera Leaves to the Acceptability and Nutrition Intake in Hemodialysis Patients

Background: One of the actions that can be taken to overcome malnutrition in hemodialysis is to improve nutrient intake. It is necessary to provide local food-based formula using Pila ampullacea , tempeh with local soybean, and Moringa oleifera leaves for hemodialysis patients. Objective: To analyze the effect of local food-based formula using Pila ampullacea , tempeh, and Moringa oleifera leaves to the acceptability and nutrition intake in hemodialysis patients. Materials and Methods: This study was carried out in Dr. Sardjito Hospital, Yogyakarta, Indonesia from February to March 2020. Subjects were 54 maintenance hemodialysis patients who met the criteria of study. The independent variable was the provision of local food-based formula, while the dependent variable were the acceptability and nutrition intake. Results: As many as 42.59% of subjects were able to consume all the formula given for three days and 50% of subjects have good acceptance of the local food-based formula. The effect of formula intake to the total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, iron showed p-value <0.05, but p- value ≥0.05 for protein, fat, sodium, and potassium. The effect of the non-formula intake to the total intake for all nutrients showed p-value <0.05. Conclusion: Most of the subjects have a good acceptance of the local food-based formula. Formula intake affects total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, and iron, but does not affect total intake of protein, fat, sodium, and potassium. The total intake for all nutrients was affected by the subject's intake of non-formula sources. This was an experimental research, which was conducted at Dr. Sardjito Hospital, Yogyakarta, Indonesia from February to March 2020. Subjects were 54 maintenance hemodialysis patients who were taken by purposive sampling, which were met the criteria of study. The inclusions criterias were maintenance hemodialysis patients 2 times a week with adequate hemodialysis, aged ≥18 years, having mild-to-moderate malnutrition based on the Dialysis Malnutrition Score (DMS), no allergy, and willing to be the subject.

This was an experimental research, which was conducted at Dr. Sardjito Hospital, Yogyakarta, Indonesia from February to March 2020. Subjects were 54 maintenance hemodialysis patients who were taken by purposive sampling, which were met the criteria of study. The inclusions criterias were maintenance hemodialysis patients 2 times a week with adequate hemodialysis, aged ≥18 years, having mild-to-moderate malnutrition based on the Dialysis Malnutrition Score (DMS), no allergy, and willing to be the subject. People with ascites, anasarca edema, having comorbid disease and blood pressure above 160/90 mmHg were excluded.
The independent variable of this study was the provision of local food-based formula, which was defined as the provision of local food-based formula to hemodialysis patients twice a day for three days. The dependent variables were the acceptability and nutrition intake. Acceptability was defined as the ability of hemodialysis patients to receive the local food-based formula which was known based on the food record form, and categorized into good acceptance (if the intake of local food-based formula was ≥75%) and less acceptance (if the intake of local food-based formula was <75%).
Nutrition intake was devided into total nutrition intake, formula-based nutrition intake and nonformula-based nutrition intake. Total nutrition intake was defined as the intake of energy, protein, fat, carbohydrates, fiber, water, calcium, phosphorus, sodium, potassium, iron from all foods, drinks, and supplement consumed by the patient, recorded using a 3-days food record form, calculated using Nutrisurvey software, compared to the patient's individual needs, then presented. Formula-based nutrition intake has the same definition as total nutrition intake, but the source of intake comes from the local food-based formula, while the sources of nonformula-based nutrition intake come from other than local food-based formula given.
Local food-based formulas are given in powder form weighing ± 36 grams per serving which can be diluted with 125 ml hot water at 90-96°C. Previous study showed that protein will be dissolved and denatured at a temperature of 100ºC. The increase in heating temperature will cause the protein to be dissolved and denatured. Protein loses its binding power to water so that the water contained in the food will come out (20). Local food-based formulas are recommended to be consumed during the morning and evening interlude hours.
This study can be carried out with the ethical elearance from the Ethical Commission of the Faculty of

RESULTS
This study involved 54 subjects who were taken by purposive sampling. The sampling process is shown in Figure 2. Subjects were given the local food-based formula for three days. Acceptability test was carried out for three days because the interdialytic time is between 3-4 days and a person's acceptability to food or drink could be seen within 3 days of administration. Subjects were asked to record food and drinks consumed during the three days using the food record form. Acceptance and nutritional intake of research subjects were evaluated on the fourth day. The subject's acceptance of the local food-based formula is shown in Figure 3.
The results of the acceptance test reported that most of the subjects (42.59%) were able to consume all the local food-based formula given for three days. A small proportion of subjects (7.41%) were able to consume 75% and 50% of the local food-based formula provided by the researchers. There were 31.48% of subjects who did not consume the local food-based formula at all because they felt nauseous and vomited when they smelled the product.
Hemodialysis patients who are categorized as having good acceptance of the local food-based formula are those who are able to consume an average of at least 75% of the product given for three days. As many as 50% of subjects had good acceptance of the local food-based formula. Table 1. Effect of formula intake and non-formula intake on total intake of hemodialysis patients The results reported in Table 1 show that formula intake affects the total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, and iron (p-value <0.05), but does not affect the total intake of protein, fat, sodium, and potassium (p-value ≥0.05). However, the magnitude of the effect of formula intake on total nutrient intake is reported to be insignificant, so it is necessary to analyze the effect of non-formula intake on total intake. Analysis of the effect of non-formula intake on total intake was carried out to compare the magnitude of the effect of formula intake and non-formula intake on total intake.
The results of the analysis reported that the total intake for all nutrients was affected by the subject's intake from non-formula sources, including supplements (p-value <0.05). The magnitude of the effect of non-formula intake on the total intake on average was greater than the magnitude of the effect of formula intake on total intake for all nutrients except calcium and iron.

DISCUSSION
The intake of the subject formula in this study depends on how much the subject accepts the local food-based formula given by the researchers. The acceptability of food is the acceptance of food served that can be accepted by consumers, the measure of the success of food management is that the food served is acceptable and the food is consumed without leaving food leftovers. Acceptance itself as a measure of patient satisfaction (21).
Acceptability of food is directly related to the interaction of food with consumers at any given moment. The factors that influence acceptance include consumer characteristics, sensory characteristics of food and taste factors. Consumer characteristics include consumer expectations, consumer innovation, consumer knowledge and trust, and consumer attitudes towards healthy and functional foods. In sensory characteristics, there are effects of aroma, appearance, taste, and texture on food acceptance (22).
Knowledge of composition, functional properties and to some extent processing steps influence whether a food product will be accepted or rejected by consumers (23). Consumers consume functional foods for health benefits such as disease prevention and access to the protective properties of food. The main factor that encourages the acceptance of functional food is its health characteristics (24). In this study, the subjects have known about the composition of the ingredients used to produce local food-based formulas, as well as the benefits that will be obtained when consuming these products, so as to increase acceptance of the local food-based formula products given.
The patient's acceptance of food affects the nutritional status of the patient. The low food acceptance will have a negative impact on nutritional status, clinical physical condition, and patient recovery (25).
This study shows quite good results, where 50% of the subjects have a good acceptance of local foodbased formula products. Clinical formula intake had an effect on increasing the intake of protein, water, and calcium in subjects. The average intake of protein and water from non-formula sources alone is still in the low category (<80% of the need), but after adding the oral nutritional support formula, the total intake of protein and water of the subject is good (80-110% of the needs are met).
The food intake of the subjects in this study was known based on the results of the 3-days food record. The use of the 3-days food record method to determine the food intake of subjects in this study was in accordance with the 2020 Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations regarding the use of the 3-days food record method to assess the nutritional intake of hemodialysis patients (14).
The nutritional requirements used as a comparison for the intake of subjects in this study are based on the KDOQI recommendations for 2020. The recommended protein intake for hemodialysis patients aged ≥18 years with a stable metabolic condition is 1.0-1.2 g/kg body weight per day. Recommended energy intake of 25-35 kcal/kg body weight per day based on age, sex, level of physical activity, body composition, achievement of expected weight status, and the presence or absence of comorbidities or inflammation in the hemodialysis patient's body (26).
Calcium intake in hemodialysis patients should be considered based on input from dietary calcium, calcium supplements, or calcium-based binders and concurrent use of vitamin D analogues and calcimetics to avoid hypercalcemia or excess calcium (14). The results of this study indicate that the average intake of calcium from non-formula sources alone is in the good category, but after adding oral nutritional support formulas, the average total calcium intake is actually excess (>110% requirement). This is because the subjects are still consuming 3x500 mg of calcium-based phosphate binders per day, so that it makes a big contribution to the calcium intake of hemodialysis patients.
The hemodialysis patient's phosphorus intake should be limited. Dietary potassium intake should be adjusted to maintain serum potassium within the normal range. The fulfillment of potassium from food intake or supplemental potassium is based on the patient's individual needs and the doctor's judgment. Sodium intake should be limited to less than 100 mmol/day (or <2.3 g/day) to lower blood pressure and Fery Lusviana Widiany, Mochammad Sja'bani, Susetyowati, Emy Huriyati improve fluid volume control in the body. Reducing dietary sodium intake was undertaken as an additional lifestyle modification strategy to achieve better volume control and desired body weight (14).
The results of the analysis of the subject's intake showed that the average intake of total energy, carbohydrates, fiber, phosphorus, sodium, potassium, and iron was still in the low category (<80% requirement) even though it had been added with a nutritional support formula. The average total fat intake was in good category, although the contribution of fat intake from formula was only very small. These results indicate that the compliance of hemodialysis patients in fulfilling nutritional intake is still not good.
The process of hemodialysis can remove most of the waste products in a short time, but some beneficial nutrients are also lost from the body through this process such as protein and water soluble vitamins. Uremia can be accompanied by symptoms of anorexia, nausea, and impaired absorption of food, so as to reduce the nutritional intake of hemodialysis patients. Diet therapy management is very important to maintain hemodialysis stability. Hemodialysis patients need adequate intake of energy, protein, sodium, potassium, phosphorus, and water (26,27).
The application of dietary management management increases the survival rate of hemodialysis patients and increases the adequacy of hemodialysis, but can cause increased psychological distress in the patient. Many difficulties may be experienced by hemodialysis patients in the practice of diet therapy management. These practical difficulties are related to changes in individual eating habits such as lack of family support, changes in taste, and lack of knowledge (28,29). Knowledge, family support, attitudes, and behavior can influence dietary adherence of hemodialysis patients in fulfilling nutritional intake according to the recommended dietary therapy (30). Adherence appears to be a multidimensional phenomenon that is patient-related, socioeconomic conditions, therapy-related, health care-related factors and contributes to nonadherence to dietary guidelines and treatment of hemodialysis patients (31).

CONCLUSION
Most of the subjects were able to finish the local food-based formula for three days. As many as 50% of subjects have a good acceptance of the local food-based formula. Formula intake affects total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, and iron, but does not affect total intake of protein, fat, sodium, and potassium. The total intake for all nutrients was affected by the subject's intake of nonformula sources, including supplements. The magnitude of the effect of non-formula intake on the total intake on average was greater than the magnitude of the effect of formula intake on total intake for all nutrients except calcium and iron. Further research is needed to determine the effect of provision of oral nutrition support formula to nutrition status, immune status, and inflammation status of hemodialysis patients.