The Faculty of Medicine at the Jagiellonian University in Krakow, in Poland, has conducted a study with men and women with overweight and obesity to assess the effects of general nutrition advice versus personalised nutrition based on each individual’s physical and behavioural traits, lifestyle and preferences.
Personalised nutrition is a new approach which aims to give individual’s unique nutrition advice based on their genetic, environmental and lifestyle factors. Personalisation of interventions may be effective in changing behaviour that will affect health outcomes, including weight loss.
We interviewed prof. Małgorzata Malczewska-Malec – clinical study coordinator, Joanna Góralska PhD and Urszula Raźny PhD – researchers responsible for carrying out the study – to learn more about the study conducted in Poland and find out about its first results.
What were the main goals of this study?
The main goal of the Jagiellonian University (JU) pilot study was to examine the effectiveness of the PREVENTOMICS platform and MetaDieta software to provide personalised dietary recommendations that enhance a reduction of weight and waist circumference in obese subjects. The objective of this clinical study was also to verify if personalised nutrition based on omics technologies is more effective in exerting favourable changes in metabolic profile compared to general dietary recommendations in subjects with abdominal obesity.
How many people participated, and which requirements had to meet?
Over 400 volunteers were interested in participating in our interventional study, 331 were assessed for eligibility and then examined by a doctor. Men and women aged 18-65 years were eligible for enrolment into the study if they had a waist circumference >94 cm (for men) or > 80 cm (for women), which indicates abdominal obesity. Based on medical history, screening lab tests, diagnosed diseases, some of individuals were excluded, and, finally, 265 participants were enrolled for the intervention.
265 participants with overweight and obesity participated in PREVENTOMICS clinical trial to assess the health effects of personalised nutrition
Can you explain a bit on how were the participants recruited?
Dissemination of information about recruitment for the PREVENTOMICS study was carried out through leaflets, posters and social media. Members of the research team, including nutritionists, doctors and nurses, handed out invitations directly to patients of the Krakow Clinic. We also disseminated information about project at seminars and meetings with students of dietetics and medicine at the Jagiellonian University Medical College, as well as through the website of the JU research group.
What participants thought about PREVENTOMICS platform and mobile app to receive personalised nutritional advice digitally?
Most of the participants felt cared for by nutritionists, especially those whose intervention was during the lock-down period and access to health care was generally difficult. Most of the volunteers emphasized that the great advantage of PREVENTOMICS platform is the opportunity to learn more about their health, based on new tests which are currently discussed in the media, e.g., the genetic risk score or microbiota status.
Regarding the use of the mobile MetaDieta application for participants, generally individuals found it to be helpful to control compliance with dietary recommendations. They always had food recommendations for the current day on their mobile device. The mobile app was also the way to communicate with nutritionist in case of questions or doubts.
What did participants need to do during the study period?
During the 4-month intervention, participants had to follow the nutritional guidelines received from nutritionists, depending on the intervention group to which they were randomly assigned. Participants in Control group received standard dietary recommendations, whereas the Personalised Nutrition group received personalized dietary recommendations based on omics analyses. The Personalised Plan group received both personalised nutrition plan, together with tips for behavioural change, which may influence eating habits and lifestyle.
Which indicators and technology did you use to assess the impact of the nutritional study on participants’ health?
Both before and after the nutritional intervention, we performed detailed measurements of body mass composition and a series of laboratory tests in blood, urine, saliva and feaces. In order to assess the impact of the interventional study on the participants’ health, we monitored classical laboratory parameters for the assessment of carbohydrate and lipid metabolism, liver, kidney and pancreatic function. Moreover, we have performed a series of non-routine biochemical tests that allow to assess in detail the metabolic complications of obesity, such as the inflammatory process, intestinal microbiota disturbance and oxidative stress. The most sophisticated metabolomics analyses in blood and urine were performed with new omics technologies.
Any preliminary results you could share with us?
It is too early for precise conclusions because we have just completed the clinical part of the project, we are in the process of data analysis and compilation. In half of the participants of our pilot study, we detected at least two classic cardiometabolic risk factors, which confirms our need for efficient dietary interventions to improve metabolic health of subjects with abdominal obesity. Most of the volunteers who followed the given dietary plans lost weight and reduced their waist circumference. However, we still have to wait for the comparison of the effects of personalized diet vs diet based on general recommendations.