PROCESS LEAD, a chew and swallow managing food that helps people eat

In the late 1990s, when our company began initiatives in medical foods, there was an important presentation given at an academic conference in the United States. The series of steps from putting food in the mouth, to chewing and swallowing—the so-called “process model”—was elucidated in detail for the first time in the world.

Up to then, research and clinical activities had considered chewing and swallowing as separate process models. However, during chewing, items that have reached a swallowable state are first sent to the throat and swallowed, and it was also found that this is made possible by complex tongue movements.

At that time, we anticipated that, in the area of clinical nutrition, there would be a paradigm shift from IV solutions to enteral nutrition, and further to nutrition based on oral intake, so we began research and development of foods to address this. For example, for patients whose chewing and swallowing functions had declined due to reasons such as cerebrovascular disease, we had just begun research from the standpoint of what physical properties of foods would make them easier to chew and swallow while also considering the risk of aspiration. For us, the concept of the process model became an important hint in product development.

Focusing on swallowing function in the area of clinical nutrition, the first product we commercialized was ENGELEAD, launched in 2006. Based on the concept “food to initiate swallowing,” it is changed to have a jelly-like consistency that even patients who cannot chew can easily swallow, proposing early initiation of oral intake. ENGELEAD obtained labeling approval from the Consumer Affairs Agency as a “food for persons who have difficulty swallowing (approval standard I)” and has come to be used in medical institutions and nursing care facilities when patients with swallowing difficulties begin oral intake.

The next development target is the chewing function. What is the next stage after swallowing whole (no chewing required)? From this perspective, we focused on the process model introduced earlier. The act of eating consists of a continuous process of chewing, bolus formation, and swallowing. Along this process, the physical properties of the food change and the food is sent toward the throat. We therefore concluded that it was necessary to develop foods focusing on chewing function as the next target after swallowing whole.

1. Initially the food has a firmness that requires chewing
2. Chewing forms a bolus that is easy to swallow
3. By the time of swallowing, it is in a state similar to a paste

It was with these concepts that we developed PROCESS LEAD. We defined a new product category called “chew and swallow managing food,” with physical properties that fall between food forms that do not require chewing, such as jellies and pastes, and forms that require firm chewing, such as chopped-and-thickened foods. We position PROCESS LEAD as one of the products that matches process from swallowing whole to chewing and swallowing.

Although PROCESS LEAD is a food product and not a drug, we have spent a great deal of time refining its physical properties and quality so that it can be used in medical and nursing care settings.

Regarding the process model, subsequent research in Japan showed that the most difficult consistency to swallow is a mixture of solids and liquids. For example, imagine miso soup with tofu. In the mouth, while you are chewing the tofu, the broth of the miso soup comes to the throat first. For persons with swallowing difficulties, they are at a stage where they can barely swallow jellies or paste-like foods, so if the liquid comes first, they may be unable to cope. The food may end up entering the trachea, leading to aspiration.

Among those with swallowing difficulties, many are older adults; some have difficulty secreting saliva, others have excessive saliva, and some have sluggish tongue movements and cannot swallow readily. Our goal was to create a product that, regardless of differences in oral function, takes on a consistency that can be swallowed safely after chewing. Therefore, before launch, we carefully assessed through physical property research and clinical studies whether the consistency was indeed appropriate.

PROCESS LEAD was launched in 2014. Formal formulation consideration began in 2009, but it took as long as 17 years from the academic presentation of the process model in 1997. Since that time, interest in food within healthcare institutions increased, and more healthcare professionals came to understand the importance of oral intake in clinical nutrition.

Patients who have used ENGELEAD in situations of evaluating and training swallow function, when they reach the stage where they can begin practicing chew and swallow and eat PROCESS LEAD for the first time, may feel that their mouth gets tired, and it is a little hard. This is because compared with swallowing food whole, the person needs to move their oral cavity more. However, as they continue to practice chewing to eat, the movements needed to chew (chewing with the molars, moving the tongue, moving the jaw and cheeks, etc.) gradually become possible. If coordinated movement becomes possible, it will be easier to progress to foods that need to be chewed. Once this is possible and there is no longer concern that one’s ingestion function will decline, PROCESS LEAD is no longer necessary.

To make PROCESS LEAD a helpful aid, we begin by helping physicians understand the product’s academic-related background, such as the process model, and the usage scenarios of chew and swallow managing food products. Recently, healthcare institutions have begun to recognize that caring for patients’ chew and swallow function can improve nutritional status and increase the likelihood of returning to their previous level of daily life. Encouraged by these changes, we will continue to work on developing products that can further draw out the ability to eat.

(Affiliated departments and job titles current as of the time of the interview.)