Personalized food produced via three-dimensional (3D) printer technology for use in the lifelong dietary treatment of hereditary metabolic diseases

Abstract

The present invention relates to a low-protein food product, produced via three-dimensional (3D) printer technology, which is suitable for the special diet used in the lifelong dietary treatment of hereditary metabolic diseases.

Description

[0001] DESCRIPTION

[0002] PERSONALIZED FOOD PRODUCED VIA THREE-DIMENSIONAL (3D) PRINTER TECHNOLOGY FOR USE IN THE LIFELONG DIETARY TREATMENT OF HEREDITARY METABOLIC DISEASES

[0003] Technical Field

[0004] The present invention relates to a low-protein food product, produced via three-dimensional (3D) printer technology, which is suitable for the special diet used in the lifelong dietary treatment of hereditary metabolic diseases.

[0005] Prior Art

[0006] The primary treatment for some patients with hereditary metabolic diseases (HMDs) is a lifelong protein-restricted diet. Non-compliance with the recommended diet can lead to life-threatening consequences, such as coma. For this reason, dietary compliance and close monitoring are of vital importance. Every step taken to increase patient adherence to the diet is crucial in this disease group. The use of 3D printer technology, which has become prominent in food design over the last 10 years, will play a remedial and empowering role in many aspects of the treatment of hereditary metabolic diseases, both medically and socially. A review of the literature shows that there is only one study on the use of this technology in patients with HMDs.

[0007] Experiences with food formulations developed via 3D printer technology for patients with hereditary metabolic diseases exist in the prior art. In a publication reported from Spain by Goyanes et al., experiences were shared regarding the diets of four patients, aged 3-16 years, with Maple Syrup Urine Disease (MSUD), which included products made with a 3D printer. In MSUD disease, a diet restricted in the amino acid leucine is implemented, and the amino acids isoleucine and valine can be added to the diet as supplements as needed. The required daily intake of protein and amino acids necessitates strict monitoring and adjustment according to age, weight, and blood amino acid levels. In this study, to increase patient compliance with their diets, personalized chewable formulas were created from isoleucine powder using 3D printer technology. The formulations were enriched with different tastes, colors, and shapes. The acceptability of this formulation by patients and their blood isoleucine levels were evaluated, and it was demonstrated that the 3D printing technique is an effective manufacturing technology for producing chewable isoleucine printlets for the treatment of MSUD, with good acceptability.1

[0008] Although the amino acid-containing 3D gummy products reported by Goyanes et al. exist as the sole example in the literature, a meal-type product suitable for the dinner table, such as a 'low-protein egg suitable for HMD patients', has never been produced. Upon reviewing the studies in the prior art, a need has been identified for the development of the food product subject to the invention: a low-protein product produced via 3D printer technology, suitable for the special diet used in the lifelong dietary treatment of hereditary metabolic diseases.

[0009] Objectives of the Invention

[0010] The object of the present invention is to develop a 3D-printed food product, prepared with low-protein, vegetable-based ingredients, that is visually, texturally, and tastefully similar to an egg, a food that children with hereditary metabolic diseases (HMDs) on special low-protein diets normally cannot consume because it would cause them to enter a coma.

[0011] Another object of the present invention is to develop a food product designed to increase patients' dietary motivation, help keep the disease under control, and prevent peer bullying and social withdrawal.

[0012] Detailed Description of the Invention The present invention relates to a food product (egg) suitable for a special low-protein diet for use in the lifelong dietary treatment of hereditary metabolic diseases, produced via three-dimensional (3D) printer technology, it comprising:

[0013] For the egg white;

[0014] • 100 grams of protein-free milk

[0015] • 20 grams of rice substitute

[0016] • 1.5 grams of salt

[0017] • 10 grams of starch blend

[0018] • 1.2 grams of agar

[0019] For the egg yolk;

[0020] • 10 grams of egg substitue

[0021] • 21,5 grams of starch blend

[0022] • 2.5 grams of carrot powder

[0023] • 0,5 grams of salt

[0024] • 105 grams water

[0025] • 1 gram of onion powder

[0026] In the production and analysis phase of the food product subject to the invention, the following procedures are applied.

[0027] Validation of the 3D Printer Parameters:

[0028] The suitability for 3D printing of the egg-like food formulation which will be low-protein, high in nutritional value, and made using fruit and vegetable powders, starch, and plant-based thickeners will be determined. Subsequently, after the 3D model of the substitute product has been created using SOLIDWORKS software, the slicing process will be performed using the CURA 15.04.6 program. Parameters that affect the printing properties, such as infill rate, printing speed, and nozzle height, will be determined through preliminary trials. Following 30 printing operations, the dimensional printing deviation will be calculated. The analyses specified in the Methods section will then be performed.

[0029] Analysis of Chemical Composition:

[0030] Protein Content:

[0031] The protein content will be calculated after the percentage of nitrogen in the samples is determined using the Kjeldahl method. (Protein determination instrument: KjelFlex K-360)

[0032] Fat Content:

[0033] The total fat content of the substitute product will be determined as a percentage (%) using the hot extraction method with a Soxhlet apparatus.

[0034] Moisture Content:

[0035] Dry matter crucibles, brought to a constant weight by being held in an oven set to 105°C for at least two hours, will be cooled to room temperature in a desiccator, and their tare weight will be taken on an analytical balance with a precision of 0.0001 g. Approximately 5 g of the homogenized sample will be weighed into the tared crucibles and dried in the oven at 105°C until a constant weight is achieved. The percentage of moisture content in the sample will then be determined from the difference in the crucibles' weights.

[0036] Ash Content:

[0037] For the determination of ash content, approximately 3 grams of the sample will be weighed into ash crucibles that have been previously brought to a constant weight in an oven at 105°C. The samples will then be dried in the oven at 105°C for 10-12 hours. Subsequently, the samples will be incinerated in a muffle furnace at 550°C until completely ashed. The percentage of ash content will be calculated from the resulting weight difference.

[0038] Color Determination:

[0039] The CIE L* (lightness), a* (red-green axis), and b* (yellow-blue axis) color values of the samples will be determined using a CR-400 Minolta Chromameter. (For example, for the color determination of the white part of the boiled egg-shaped product).

[0040] 10 g of the sample will be weighed, mixed with distilled water at a 1:10 ratio, and homogenized for 1 minute using an Ultra Turrax (Miccra 0-9, Germany). The pH values will then be determined with a Hanna HI 221 model pH meter. Before the measurements, the pH meter will be calibrated with pH 4 and pH 7 buffer solutions.

[0041] Texture Profile Analysis:

[0042] The values for hardness (N), cohesiveness, chewiness (N mm), and springiness (mm) of 30 printed samples will be determined using Texture Profile Analysis (TP A). For this purpose, a TA-XT plus Texture Analyzer (Stable Micro Systems, USA) will be used. The analysis conditions will be modified according to the structure of the produced samples. The hardness, cohesiveness, chewiness, and springiness properties of the products will be compared with the textural properties of a boiled egg.

[0043] Determinati on of Microstructure :

[0044] The surface morphology of the produced products will be exami ned using a scanning electron microscope (SEM) (ZEISS, EVO 40).

[0045] Sensory Analysis: During the product development process, the sensory analysis of the products to be developed within the scope of this project will be performed in the Sensory Analysis Laboratory' of the Food Engineering Department. For this purpose, a hedonic evaluation of important product-specific sensory attributes (such as color, appearance, flavor, texture, and overall liking) will be conducted. The sensory analysis of the final developed 3D foods will be performed via consumer acceptance tests, using a 5-point smiley face scale with patients with HMDs as panelists.

[0046] The aforementioned analyses will be performed before the products are ready for consumption, and the final version of the product will be created. The initial tasting of the products will be under the supervision of the researchers, and a sensory analysis will be applied. Since these 3D foods are produced from low-protein, vegetable-based ingredients that are normally permitted in the patients' diets, they will not pose any obstacle or problem for the patients, who will also be able to continue with their normal diets. Each product will be produced to match the calorie count of the product it is modeled after. For example, the plant-based, 3D egg-shaped product will be produced to have 70 kcal, the calorie count of a normal egg, and a diet list will be created taking into consideration the patient's required daily calorie intake. Patients will be asked to keep weekly consumption records of their normal foods at home. The records will be monitored very closely by a metabolic dietitian. Patients will be closely followed up with measurements of blood amino acid levels and other routine tests (blood sugar, etc.) as part of the routine examinations performed for these patients at our hospital. A questionnaire querying psycho-social improvement parameters will be administered to the patient and their family.

[0047] Sample Size and Statistical Methods:

[0048] Patients who are followed at the Department of Pediatric Metabolism of Ankara University's Faculty of Medicine, have a diagnosis of a hereditary metabolic disease requiring a lifelong low-protein diet, and who, along with their families, have agreed to participate in the study, will be included. The estimated target population consists of 15 individuals. The obtained data will be analyzed by the research team using the SPSS software program. In the analysis of the data, descriptive statistics will be presented as mean ± standard deviation for normally distributed variables, as median (minimum-maximum) for non-normally distributed variables, and as frequency (n) and percentage (%) for nominal variables. When comparing two groups, the significance of the difference between means will be analyzed using the t-test, and the significance of the difference between medians will be analyzed using the Mann-Whitney U test. Nominal variables will be evaluated with Pearson's Chi-Square (%2) test or Fisher's exact test. When investigating the relationship between continuous variables, it will be evaluated with Spearman's correlation test when the distribution is not normal, and with Pearson's correlation test when it is normal. Results will be considered statistically significant for p < 0.05. All data will be presented in the form of data lists and tables.

[0049] The food product subject to the invention will be a step towards facilitating the lifelong diet that the aforementioned patients must follow to continue their lives without neurological sequelae, and there are no similar examples in the literature for the production of a 'low-protein egg' for this diagnostic group. Existing vegan products contain plant-based protein. Even if the same device is used, very different outputs in terms of content will be obtained, and it will serve a different population. Patients diagnosed with hereditary metabolic diseases (HMDs) who are on low-protein diets have many diet-related difficulties and problems. Many serious problems can be observed, which are very significant for their health and can sometimes be severe enough to cause irreversible physical and mental disabilities, such as; the poor taste of the formulas; difficulty in accessing easy-to-consume foods (due to high cost and a limited number of suppliers); the difficulty and laboriousness of preparing meals at home from low-protein powders and liquids; the very limited availability of low-protein recipes; peer bullying experienced by patients who must consume special medical formulas at school; patients feeling excluded and lonely alongside family members who eat a normal diet; an unwillingness of the patient to eat in public during school age and adolescence due to embarrassment over the special medical formulas, which are mandatory for meeting daily calorie needs and performing normal vital functions, leading to dietary non-compliance; a reluctance to meet with friends in social settings during adolescence and young adulthood, social withdrawal, and a rebellious attitude towards their condition and the occurrence of dietary transgressions ("cheating"), which leads to the aforementioned serious health consequences.

[0050] With this invention, the aim is to create alternative foods suitable for their diets, produced with a 3D food printer, as a solution to the dietary difficulties experienced by patients. In this context, it is planned to print products such as eggs which are forbidden for patients to consume using 3D printers with low-protein, vegetable-based ingredients. In this way, for example, a child patient with an HMD having breakfast with their family will be relieved of feelings of being 'different,' 'sick,' or 'excluded,' thanks to the 3D-printed, low-protein, vegetable¬ based, boiled-egg-like product on their own plate. This will also be a solution for the emotional discomfort experienced by other family members who eat a normal diet. Furthermore, thanks to this technology, foods can be produced with shapes and colors that are appealing to children, allowing for more comfortable consumption at school and in social settings. This, in turn, will lead to increased dietary compliance and provide very significant contributions to their health. Moreover, it may even be possible for patients to offer these products to their friends at school, which would break the perception in their peers' words that the patient's food is 'bad formulas / sick people's food' and would contribute to developing peer empathy. Through this invention, the following will be investigated: how well the 3D-printed foods are tolerated by patients with HMDs; what percentage of their diet can be provided by these products according to dietary consumption records; and how blood parameters trend after consumption. With these products, significant alternatives will be added to the patients' dietary options, and contributions will be made to their dietary motivation through psycho-social benefits. Moreover, it may even prevent the permanent neurological and physical disabilities that can arise from dietary non-compliance a condition that affects the patient's entire life and society.

[0051] The initial patient experience outcomes regarding the product subject to the invention are specified below.

[0052] Of the 15 patients who participated in the study, 8 (53.3%) were female and 7 (46.7%) were male. The median age of the patients was 9.0 years [range: 3.0-12.0], Eleven of the patients (73.3%) had a diagnosis of aminoacidopathy; of these, 7 were diagnosed with tyrosinemia type 1 and 4 with phenylketonuria. Three of the patients were diagnosed with organic acidemia, of whom 2 had methylmalonic acidemia and one had glutaric aciduria type 1. One patient had a diagnosis of a urea cycle defect (OTC deficiency). A product tasting was conducted with the patients, and the results are presented in Table 1.

[0053]

[0054]

[0055] Table 1 : General satisfaction of the participants with the products and the results of the hedonic sensory test

Claims

CLAIMS1. A food product (egg) suitable for a special low-protein diet for use in the lifelong dietary treatment of hereditary metabolic diseases, produced via three-dimensional (3D) printer technology, characterized in that it comprises;For the egg white;o 100 grams of protein-free milko 20 grams of rice substituteo 1.5 grams of salto 10 grams of starch blendo 1.2 grams of agarFor the egg yolk;o 10 grams of egg substitueo 21,5 grams of starch blendo 2.5 grams of carrot powdero 0,5 grams of salto 105 grams watero 1 gram of onion powder.

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