GI tolerability: transferring a medical assessment device to the food sector

Gastrintestinal (GI) tolerability of probiotics, prebiotics or novel food, the impact of ingredients, according to their dosage, on satiety, on digestion… In many cases, food professional are required to test the GI tolerability of their products. A tool from the medical sector could prove to be very useful in this regard: the Smartpill.

Since 2008, the Smartpill as become an innovative tool for obtaining precise and non-subjective data regarding GI tolerability. Although initially reserved for medical usage, an innovative model study and a dedicated protocol have now been developed to allow the use of smart pills to be transferred to the food sector. Find out more below.

Assessing the GI tolerability of food products: methods borrowed from the medical sector

Dietary supplements, foods for medical purposes or with claims in the area of GI comfort or satiety, novel foods, infant nutrition, or determining the dosage of a specific ingredient: evaluating GI tolerability is often a prerequisite for an application for pre-market authorisation. This often takes the form of assessing how patients feel regarding possible GI discomfort following the ingestion of the food in question, but also of obtaining objective data.

The classic assessment methods

It is generally recommended to combine subjective assessments (for example, the sensation of hunger or GI discomfort using validated medical scales) with objective evaluations in order to obtain a comprehensive and reliable picture of GI tolerability.

According to the usual procedures, one of the non-subjective assessment methods relies on abdominal x-rays or whole-gut transit scintigraphy that are able to mainly detect accelerations in gut transit or in gastric emptying, these being some of the signs of gut intolerance.

But these two techniques are rather invasive and have certain limits. They are carried out using an opaque capsule swallowed by the patient, and require several x-rays or scintigraphic scans at several intervals over a short period, and thus expose the patient to radiation. Finally, they allow researchers to obtain fairly limited data linked to the distance covered in the gut by the opaque capsule measured on the x-ray image (called gut transit time). 

Another non-subjective assessment method

Developed in 2008 by MedTromic, the Smartpill is more and more widely used for assessing GI tolerability. Initially, it was considered a medical device containing an intra-body sensor and certified by the various medical authorities, for example via an NDA in the USA, or by the ANSM in France.

This device includes several elements:

• A small capsule (26x13 mm) equipped with 3 types of sensors (temperature, pressure and pH)
• A portable control box that gathers up to 24 hours of data. Installed on the patient, it allows them to stay in their home during the evaluation.
• A software that receives the data gathered by the control box..

“With this device, we can gather data every 40 seconds over a total of 24 hours, or even up to 5 days for one Smartpill,” explains Florent Herpin, scientific affairs coordinator at Cen Nutriment.

Multiple advantages

The first advantage of this device is its ease of use. “Patients says themselves that this system is much more practical as it requires them to travel less and limit exposure to radiation from x-rays,” confirms Florent Herpin. “The results are obtained in much more realistic conditions, which is important when we know that the context of a meal can have an impact on transit and satiety.”

In addition, the Smartpill can gather data on several criteria simultaneously (temperature, gut transit time, pH, etc.), unlike radiological scans that can only focus on one criteria. “In medicine, this device can replace both scintigraphy and radiology, and helps to detect anomalies in gut transit in a much less invasive way for the patient.”

Florent Herpin explains: “using the software, we can optain a graph that summarises the three main indicators (pH, pressure and temperature). From these elements, we can deduce the varying gut transit times in the whole GI tract or one part of it (stomach, small intestine, or bowel). This data on the contraction and pressure in the antrum and the duodenum can also be used to calculate motility indexes."

“This very precise picture is essential for studies on food products where the scale of physiological modifications is often only small to moderate.” 

What potential is there for transferring the Smartpill to the food sector?

Enough usage data to consider a transfer

For Florent Herpin, the interest of this device is not limited to the medical sector. "Today there have been over a dozen clinical trials carried out using the Smartpill. As a non-subjective assessment method, it has progressively become more reliable. And since it is used more and more widely, we are starting to have enough perspective and publications to identify the best conditions of usage - and to consider transfering the device to other application areas, including food."

He cites two recent publications: one on the effects of glepaglutide on patients with short bowel syndrome, and another regarding the effects of a special diet using rye bread on patients with irritable bowel syndrome.

"It is a tool with a high potential for studies in the GI area to objectively focus on certain GI symptoms felt by healthy volunteers or patients following the consumption of certain food products."

Calibrating a protocol for application in the food sector

Since the beginning of 2021, a team within Cen have been working on an innovative study model for transfering the use of the Smartpill to the nutrition sector, and thus for use by food manufacturers.

Florent Herpin explains: "to adapt this device to a food application, we have developed a specific method, validated by our research centre: what subjects to include, the timeframe etc. There are a number of parameters that need scientific validation in order to ensure reliable results. For example, according the main assessment criteria chosen from the Smartpill's data collection, the number of patients to include can vary."

Currently, Cen Nutriment has worked on this assessment method of GI tolerability for novel foods and considers today that they are able to adapt the study protocol to a much wider range of food products aiming for health claims in the area of GI comfort.

Florent Herpin indicates that "we also need to keep in mind that the use of this device is not necessarily adapted or adaptable to all situations, for scientific reasons but also regarding a company's marketing or budgetary considerations."

One constraint: a standardised meal

The main limitation for transfering this device to the study of food products is, according to Florent Herpin, the need to use a standard meal format. "Without this, the variations can be too great on the parameters studied by the Smartpill."

Currently, a meal-replacement bar can be used to standardise the food intake of all patients in the cohort and to avoid external factors influencing the results. "It is also possible to use a standardised "normal" meal," he explains.

A number of potential applications

“The further we go, the more interest is being generated,” says Florent Herpin.

Indeed, there a large number of potential applications in the food sector. For example, the Smartpill is able to obtain an objective measurement on faster or slower gut transit times for dietary supplements or fibre-enriched products.

Another possible application concerns satiety, linked to gastric emptying (the faster the stomach empties into the small intestine, the sooner a feeling of hunger will return). “An article has been published on this subject in Appetite,” says Florent Herpin. “The study focused on the effects of meals high in fibre, both liquid and solid. The study showed that a solid breakfast slowed gastric emptying.”

Finally, this device could make it possible to evaluate the impact of an ingredient on gut transit according to its dosage. “This makes it possible to test several doses, to identify the dose that causes the highest or lowest acceleration of gut transit time – this is of particular interest for novel foods,” he concludes.

By adapting study protocols, this assessment method can be applied to a number of situations: for novel food to evaluate their GI tolerability, for dietary supplements or enriched foods aiming for health claims in gut health, for specialised medical foods formulated for patients with GI disorders, or indeed food products or ingredients that have an effect on gastric emptying relating to allegations around satiety.

Go further

Without wholly replacing subjective assessments of how patients feel, it is possible to use a Smartpill to obtain very precise data for evaluating food products. “The goal is not to limit assessments to only this device but to find a correlation between the two types of data: on the one hand, the clinical data based on what patient feels, and on the other hand the biological and physiological data.”

To find out more about the R&D activities of Cen Nutriment, or to meet Florent Herpin, feel free to contact Maria Isabel Cisneros, a Vitagora innovation engineer: maria-isabel.cisneros@vitagora.com.

Further reading:

• Measuring the links between food and emotion... using emojis 
• Microencapsulation: an effective solution for protecting active ingredients

Keywords

Gastrointestinal tolerability, novel food, medical analysis, nutrition, dietary supplements, health claims