Immunomodulating Food

COVID-19 is a viral disease with a high rate of infection, it was discovered a few months ago and it does not have effective approved medical treatments, therefore, society must learn to manage it effectively and responsibly.

Our project focuses on the development of a treatment based on the consumption of an immunomodulatory food formulated with macro, micronutrients, and bioactive compounds that mitigates the infection of this viral disease.

The consumption of this product allows a future adaptation from the diet to protect and strengthen the immune system through the intake of nutrients. With this is obtained an inhibition of the contagions of the virus or reduction of the symptoms associated with this disease, promoting the economic reactivation, the reduction of costs associated with treatments carried out in intensive care units (ICU), and the reduction of their mortality rate.

Currently, the world is in a state of alert due to a highly contagious viral disease (COVID-19), classified by the WHO as a pandemic. There are not medicines for its control or treatment yet. Until 18 of June, there are 8.475.089 infections and 452.036 deceased people are reported.
Colombia has 57.046 confirmed cases and 1,874 deaths, which is the behavior of the virus is still under study, evaluation, and analysis to fully understand the characteristics, symptoms, and immune responses of the host to fight infection.
This situation has led countries to adopt isolation measures to slow the progression of the disease and strengthen the health system, as a consequence negative economic repercussions are estimated, which in Latin America can reach 5.2%.
Also, an increase in the unemployment rate in the country has been reported, reaching values of 19.8%. The costs of the health sector have also increased due to the care required by people in intensive care units (ICU), estimating expenses per patient equal to 711.84 USD per day.
This makes it necessary to develop effective solutions with scientific support that prevent and mitigate contagion to promote a safe economic reopening of the countries affected by the pandemic.

Our solution combines food science and health, which are integrated synergycally for the development of an immunomodulatory food that contains micro-macro nutrients and bioactive compounds that trigger two mechanisms of protective action in the body aimed at providing a strengthening the immune system.

The processes involved in the production of food include technologies associated with biotechnology, micro-nanoencapsulation, and spray drying. They give it qualities that increase its shelf life and facilitate the uptake of nutrients by the body because the product is in powder and it supplied orally when resuspended in water.

It benefits the general population, men and women between 18 and 90 years old, including groups with the highest risk of vulnerability, such as those responsible for continuing production work in the country. An example of this is the Colombian health professional, who are 40,000 nurses and medicals, of which it is estimated that around 30% will be disabled due to constant contact with patients infected with SARS-CoV2.

Older adults are another vulnerable population since they have the highest death rate with COVID-19 due to pre-existing conditions.

The food has been developed from a series of technical validations with experts in many areas of health to accept the development of the product, which provides advantages associated with the development of protection system for the organism, offering the possibility continue with productive and recreational activities. Finally, to reach the final prototype were performed a sensitivity, acceptability, and tolerance tests with a sample from the target population.

Immunomodulatory food is a solution that provides preventive and mitigation treatment to protect vulnerable populations, mainly those are on the front of the line of battle, such as health professional, who must continue with economic productive activities.

This treatment is accessible, affordable, and easy to consume, which allows us to combat the viral disease of COVID-19 and future pandemics caused by viral agents that develop as a consequence of globalization and climate change.

Technological innovation is based on the development of the immunomodulatory food that, through the synergistic effect between vitamins, minerals, and bioactive compounds, generates a barrier with the mode of infection of the cells - currently known - and the response capacity of our organism to strengthen the immune system of the innate and adaptive mechanisms and the direct protection of the viable cells of the body granted by the intake of bio-compounds.

The production process involves biotechnology, micro-nanoencapsulation and spray drying, techniques that protect nutrients, bioactive compounds and improve bio-absorption, also being a powdered product that confers ease of storage, transport, preparation and consumption.

In contrast to other products that are on the market, this solution has technical validations of the bioactive compounds used, supported through various scientific evaluation methodologies.

ALSEC has a technological autonomy, becoming one of the leading companies in Colombia using biotechnology, micro-nanoencapsulation, which are processes that involve the incorporation of bioactive components from food into small nano or micro-sized capsules to protect them from physical or chemical reactions or for the controlled release of nutrients and Spray drying is a unitary operation where a liquid product using a hot gas stream instantly produces a powder.

These technologies added to the knowledge of the science of food and health allow the development of the immunomodulatory food, which is made with key components that promote the synthesis of proteins that interfere with immunological responses from identification, coding, signaling, and activation of phagocytic cells responsible for eliminating the pathogen.

Bioactive compounds trigger a direct protection mechanism where it binds to the cell membrane receptors used by the virus to internalize the cytoplasm and replicate its genetic material. The sites of communication between virus-cells occupied, its replication is inhibited and endocytosis reactions begin to control the infection.

Both mechanisms focus on controlling the viral concentration within the body to suppress it and prevent the destruction of viable cells, this allows the infection does not develop or reduce symptoms, avoiding reaching a severe state, facilitating care and treatment used.

The immunomodulatory food has been evaluated in different immunology laboratories and bio-compounds have been quantified through different experimental methods used in the pharmaceutical and food sector. These evaluate the efficiency and safety of substances incorporated in the development of new medicines and food. Some of these are:  

• Technical validations by health professionals with multiple specializations (immunologists, virologists, epidemiologists, statisticians, internists, gastroenterologists, and nutritionists), who approved the development of the product for the proposed purpose.
• In silico validation of the inhibition of the compounds to SARS-CoV2. The protective action was quantified through the AutoDock molecular software obtaining inhibition results greater than 50%.
• Review of biosecurity aspects of the molecules found through scientific articles in specialized databases with more than 40 results that support their consumption and application.
• Biochemical analysis of molecules through in vitro tests focused on determining the cytotoxicity of substances in human cells and the effectiveness of inhibition of bioactive compounds. These trials were carried out by research groups such as the PHYSIS group and the immunovirology group to the University of Antioquia.
• Quantification analysis of the content of the biocomponds in the product, to verify the reported nutritional contents.

The pandemic caused by the COVID-19 disease has put countries in trouble by not being prepared to face a viral disease, nor having the ability to respond quickly to the development of a treatment that protects people from this type of infection. This situation has led the economic and social sector to reinvent itself to continue with its productive and leisure activities. However, the incorporation of these changes will take time, and the repercussions present by the isolation measures are notorious.

With all these, ALSEC defined that the main objective was to develop an immunomodulatory food as a preventive and mitigation measure and purposely intelligently accelerate the process of reincorporation of people to the economic activities of the countries in a safe way by mitigating contagions by SARS-CoV2 and reduce the severity of the symptoms that this disease causes.

Food formulation has included the union of many knowledge, achieved through scientific alliances where support has been given to evaluation processes at the technical and laboratory level.

The projection will be the integration of more entities to allow the clinical evaluation of the product to determine the effectiveness in reducing contagion in populations at higher risk. Finally, our solution will be a medically recommended treatment for emerging viral diseases caused by the SARS-CoV and MERS-CoV family, causing recent pandemics in these last two decades. Likewise, an advanced development is projected in terms of the presentation and consumption of the product, seeking an easy intake and assimilation of the components that make up this food.

Until today, the product is in an advanced stage of development, it is projected for this year, to begin with, a scientific evaluation based on a clinical study with health professionals, in which the food will be supplied to 650 doctors and nurses for two months to check the effectiveness of the product in the field.

Once the clinical study is completed and its results have been obtained, it is planned to benefit the country's professionals health. They are approximately 40 thousand professionals.

Through alliances with public and private entities in Colombia, it is expected to include older adults, thus serving approximately 6.5 million more people within a year. For the next 5 years, the product will be offered in different national sales channels, medical recommendations so that the general public can access its consumption, as well as position itself in the international market. Parallely, through alliances and calls for international cooperation, it is expected to impact other remaining vulnerable populations in the country

Our main objective for this year is to obtain the financial resources that allow us to carry out the clinical trial to evaluate the effectiveness of the product in terms of strengthening the immune system and mitigating the spread of SARS-CoV2. During the first year, we expect to have an industrial-scale production of the immunomodulatory food to distribute it in the national market and initially impact health professionals and the elderly.

For the next five years, the plan is to have consolidated sales and brand recognition by doctors, public and private institutions and the general public, in such a way that it covers the national and international market and can carry out other evaluations in the field based on clinical studies that allow us to determine the effectiveness of the immunomodulatory food against a range of viruses of the SARS-CoV or MERS-CoV, et, family that currently plague the world population and that do not have a proven specific cure or treatment.

Also, we will extend the formulation to obtain high effectiveness of the product by including other populations such as children, teenagers, or pregnant mothers who are not served by the current product and will delve into new presentations such as pills or capsules that facilitate their consumption.

The barriers that put the development of the project at risk within this year and the next five are:

• Supply problems mainly due to the trade measures to which the markets around the world are being subjected to avoid a high contagion rate, in addition to their availability and price in the market.
• The support of product sales and the search for alliances that strengthen the project and support its development.
• Delays in the issuance of quality certificates, required for the commercialization of the product.
• The rejection of the product by consumers caused by sensory tastes or lack of tolerance and adherence during its intake.
• Limited resources for the execution of clinical studies that demonstrate the effectiveness of consumption.

• The supply activities will involve active communication with the supplier to send a periodic purchasing plan to ensure the availability of the raw material according to the times set for our production.
• Marketing activities will be promoting the product, also through divulgation events, technical consultancies, workshops, and presentation of the proposal to international cooperation calls that promote its commercialization.
• Work hand in hand with consultants specialized in issuing these certificates, to avoid rejections.
• Product acceptability, adherence, and tolerance studies will be designed with a representative sample of the target population to determine improvements and ensure a successful entry into the market.
• We will continually seek the participation of our solution in calls that finance the pending activities to be carried out.

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Development of the project includes the following personnel:

FULL TIME:

• Company R&D group has worked in the last 4 months on this development. Formed for 10 people.
• Contractors for carrying out the clinical trial: Waiting for it, but the association of 4 professionals is estimated.

PART-TIME

• Quality, production, purchasing, and commercial areas of the company promoted the development of the prototype. These activities have involved 50 people.
• Scientists from research groups at the University of Antioquia and the Universidad Pontificia Bolivariana (UPB). Formed 10 people.

ALSEC ALIMENTOS SECOS SAS is a technology-based company that has stood out for incorporating science, technology, and innovation for more than 13 years in the development and production processes of ingredients and diversified products in its marketing lines. In its years of experience, the company has had numerous awards and recognitions for using advanced technologies in the elaboration of ingredients and products for the food, cosmetic, and pharmaceutical industries.

Since 2019, the research group has been classified as a category C research, technological development, and innovation group by the Ministry of Science, Technology, and Innovation of Colombia. His business philosophy views the democratization of nutrition by formulating functional ingredients and products to reduce the world's malnutrition problems.

It is also recognized for its initiatives aimed at fighting acute malnutrition in children through highly nutritious food, with indigenous and sustainable flavors of the region; products for diabetics and co-development focused on developing functional foods for epileptics

Finally, some of our functional powdered foods have a scientific endorsement obtained from clinical studies, have tests of acceptability, adherence, and tolerance carried out with the target populations

The project has been developed hand in hand with specialized research groups related to Biotechnology and health areas such as the University of Antioquia, Pontificia Bolivariana University (UPB) and ANDES university, who have supported us to carry out consulting and Product effectiveness evaluation based on in silico, in vitro analysis and the development of the clinical study methodology since they have all the technical capabilities and experience.

ALSEC has 13 years of experience, is located in La Estrella-Antioquia- Colombia; Our value proposition is focused on offering high performance powdered ingredients for the food, pharmaceutical, and cosmetic industries, under the lines of fats - oils, fruits - vegetables, dairy products, and specialties, as well as functional products focused on improving the quality of people's lives from food taking into account their eating habits and nutritional needs according to the stage of life in which they are. The key activities involve a production system that combines biotechnology, microencapsulation, spray drying, and nanotechnology technologies, giving food technological functionality and longer shelf life; with strategic partners such as research and technological development groups from different universities in the world; the relationship with our customers is based on trust and speed of response to offer functional ingredients and products with ease of storage, food preparation, consumption and digestion of nutrients. The marketing channels are through three sales channels: industrial line: national and foreign trade, food services, and social innovation.

The source of income for the company is through the sale of functional ingredients and products in search of democratizing nutrients around the world, fighting malnutrition problems through the consumption of these, being affordable, accessible to populations, involving the most vulnerable groups in society pregnant mothers, children, the elderly and indigenous and Afro-descendant communities.

Financial sustainability will be obtained from the sale of the immunomodulatory food and the commercialization of a broad portfolio with the other products that the company has through the business lines. If necessary, ALSEC has the financial capacity to invest capital in those processes that may require it and will actively seek alliances with public and private entities and calls for international cooperation that contributes to the execution of complementary scientific evaluation activities, positioning of the product in the market and the expansion of the business model.

This award is an opportunity that allows generating visibility to the solution with benefits from different points:

1. Continue to gather the financial resources for the development of the clinical study with the health professionals, since it is a great challenge to demonstrate the proposed effect clinically.
2. Develop and execute a marketing strategy for product positioning in national and international markets
3. Create and implement a work route to increase the probability of achieving strategic alliances with public and private organizations that benefit the vulnerable populations mentioned in this proposal.

From my position as CEO of ALSEC, I consider that the presentation to the call and the award is in search of a benefit for society, in response to an early and proactive reaction of our R&D group when thinking as from the science of There may be a preventive solution for food in the future to avoid contagions and deaths caused by the SARS-CoV2 virus and not limit ourselves to the fact that the solutions are those that solve the problems of the present, that is, in acting in a curative way.

From my position as CEO of ALSEC, I consider that the presentation to the call and the award is in search of a benefit for society, in response to an early and proactive reaction of our R&D group when thinking as from the science of There may be a preventive solution for food in the future to avoid contagions and deaths caused by the SARS-CoV2 virus and not limit ourselves to the fact that the solutions are those that solve the problems of the present, that is, in acting in a curative way.