What is MicroBiar, a study to improve people's quality of life and why is it unprecedented in Latin America

“MicroBiar is a scientific study, but also of social commitment”, clarifies first of all Juan Pablo Bustamante, a researcher at CONICET, professor of Biomedical Engineering at the Universidad Austral and a degree in Bioinformatics at the National University of Entre Ríos and one of the two main researchers of an unpublished study in the country and Latin America, both in terms of its magnitude and its methodology. And what, Bustamante points out, has the goal of obtaining results that help people improve their quality of life.

The study aims to learn how dietary changes can improve the microbiota, the set of microbes that live inside our body. “But we also want to know the microbiome, that is, what these microbes are doing in the body and how they help or worsen us in health or disease processes,” explains Bustamante.

To this end, 360 people will be followed up with clinical parameters for two years.

MicroBiar is the result of wills and resources that came together. It began to take shape when Bustamante was working in a leading American company in the international market for microbiota studies applied to the clinic and won an international grant of $450,000. On his return to Argentina, Dr. Gustavo Frechtel was contacted, who was also doing research in the area thanks to a grant from the Institute of Immunology, Genetics and Metabolism (INIGEM). They decided to combine efforts and economic resources, to which funding from CONICET and that of Universidad Austral were added.

Today they lead a team of more than 90 professionals from different areas such as medicine, nutrition, computer science and engineering.

What is the project like

The study has a total of six stages:

• The pre-selection.

• Recruitment.

• The start of face-to-face consultations, which will be at the Hospital de Clínicas of the City of Buenos Aires, headquarters of the project. There, participants will be given a complete medical history.

• A food record for the last week prior to admission to the study.

• Taking samples of blood and fecal matter.

• Follow-up. People with obesity, prediabetes, or type 2 diabetes will receive nutritional and physical activity counseling during the two years of the study.

The first five stages constitute what researchers call the transversal phase: they serve to take the photo of a particular moment. The sixth, follow-up, is the longitudinal phase, which involves the monitoring of many variables over time and which distinguishes MicroBiar from the vast majority of clinical studies.

In the transversal phase, people between 30 and 60 years old can participate regardless of whether they have obesity, prediabetes or type 2 diabetes.

But those who have these diagnoses will be those who participate in the follow-up over the course of two years. This population will be divided into two groups: one for non-intensive intervention and one for intensive intervention. Both will be given personalized nutrition plans. The first group will follow the guidelines of the American Diabetes Association, while in the second group a meal plan will be made based on these guidelines, while emphasizing plant-based and whole foods. Both will be given physical activity guidelines.

“We have every reason to think that the intensive intervention group will show significant changes in relation to the other,” says Ariel Kraselnik, cardiologist and specialist in vegan and vegetarian food.

Kraselnik emphasizes that, beyond the hypotheses, participating in MicroBiar is a great opportunity, regardless of which group each person is part of: “Microbiota studies are not done in routine, but only in these research contexts and are very expensive. The analyses are going to be an advantage over traditional interventions in any hospital.”

In particular, monitoring includes studies of the microbiota and gut microbiome, clinical laboratory analyses, metabolites and biomarkers, records of evolution of food plans, anthropometric measurements including fat folds and muscle diameters, and physical activity records.

But patience: MicroBar is still in the pre-selection stage, which will last, at least, until the end of May. “The first thing is to advise the participants and that they understand well what the study is like. There are many criteria for inclusion or exclusion in clinical trials. On the one hand, clinical conditions or age range. But also something that is one of the most important considerations to evaluate is commitment and adherence. We need people to be committed and comply with the progress and follow-up of the study,” clarifies Bustamante.

A unique research

“In Argentina and even in Latin America, there are no such interventions on lifestyle medicine or research of this magnitude. When it comes to microbiota, there are very small studies of no more than 60 people. But they are transversal, a photo of a certain moment, not longitudinal”, clarifies Bustamante. He adds: “We, in addition to the microbiota, are going to study the microbiome, so we can relate the microbes in our organism to health and disease factors.”

Kraselnik notes that worldwide “studies on this subject are usually small and last a few weeks”.

Such a large intervention with such intensive monitoring is possible, in part, thanks to different sources of funding, including two US companies.

For his part, Dr. Lujhon Florez, a physician specializing in internal medicine and diabetology, who is also participating in the study, points out that there have been some similar studies with good results, including the United States Diabetes Prevention Program (DPP), published in 2001 in the New Journal of Medicine (film). “It is possibly the best-known study on diabetes prevention in the world and it managed to show that lifestyle in general was twice as effective as the drug used in people with prediabetes, such as metformin,” he explains. He also cites a six-year study conducted in Finland, with similar results. “These programs were effective, but in very different cultures. We have to adapt them”, he explains.

Lifestyle

MicroBiar then seeks to demonstrate the impact that lifestyle can have on people with obesity, prediabetes or type 2 diabetes.

Although lifestyle medicine is based on six pillars, the study will focus on one, diet (the others are sleep, physical activity, interpersonal relationships, stress management and toxic substance use). “As it is a study, we must avoid adding 'noise': if we start to tell participants that they should sleep a certain amount of time or manage stress, it would be difficult to identify what factor played a role. In both groups, they are going to talk about physical activity and they will be followed up,” explains Florez.

“The treatment that the non-intensive intervention group will follow does not place as much emphasis on eating plant-based foods. And they are the foods that Argentines consume the least, despite the fact that they have many benefits, such as improving blood glucose levels or producing less inflammation,” says Kraselnik. The doctor also points out that, in order to observe possible improvements in the food factor, in cases where possible, it will be sought that the selected people do not take any medication associated with type 2 diabetes.

Florez, on the other hand, emphasizes that participants will play a key role, as in lifestyle medicine, a paradigm that, the doctor says, “has been shown to be effective in preventing, controlling and reversing conditions such as type 2 diabetes.”

“Lifestyle medicine,” Florez continues, “is not in contrast to traditional medicine, but rather complements it. But one important difference is that in the traditional approach we don't have faith in the patient, we don't 'waste time' in insisting that they exercise or eat in one way. In lifestyle medicine we believe that the person is willing to change, but we must learn to motivate them. Who practices medicine should know about behavioral changes.”

Along these lines, something that will make the difference between the two research groups will be the frequency of controls. “We are going to have a more personalized follow-up through food records on WhatsApp, workshops or groups with similar interests. We are going to use tools to get to know the person, about what stage of behavior change they are in, in order to encourage them and generate effective strategies to accompany them,” says Florez. “We know that just telling participants that they have to eat fruits, vegetables and legumes will not have a significant impact on people,” he says.

That is why, Bustamante clarifies, they prefer to speak of people as “consultants”. The definition says a lot about this approach to medicine and the future of this study: “They play an active role, they are not patients who abide by information.”

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This note is part of the Solutions for Latin America platform, an alliance between INFOBAE and RED/ACTION