Plain English Summary
Background and study aims
Being obese is known to increase the chance of developing several health problems, including heart disease, type 2 diabetes, fatty liver disease, and some cancers. It results from the interactions of different factors, including genes, metabolism, behaviour, and environment. The latter factors include people’s eating habits and how much exercise they do. However, both gaining and losing weight are complex because it is not known how the different factors interact.
This study aims to improve the health of obese people by developing personalized eating plans. In order to assess and characterize the patient's health status before and after dietary intervention, the project will measure various metabolic biomarkers. The aim of the study is to compare the effects of personalized dietary advice based on Preventomics software with general dietary recommendations on weight loss and improvement in metabolic health status.
Who can participate?
Healthy volunteers aged 18 to 65 years old with a BMI between 25-40 kg/m2 with abdominal obesity.
What does the study involve?
Volunteers will be allocated in one of three groups: a control group, in which volunteers will receive general advice from a dietitian about how to improve their diet; a personalised nutrition group, in which participants will use MetaDieta app and the PREVENTOMICS’ app; and the personalised plan group, in which, in addition to a personalised diet through the use MetaDieta and PREVENTOMICS’ app, will also receive prompts to help change food and lifestyle choices. The intervention will last 4 months. Before and after the intervention, each participant will have blood, urine, saliva, and faeces samples taken for laboratory tests.
What are the possible benefits and risks of participating?
Participants may benefit from losing weight and receiving laboratory test results as well as scientific advice on how to improve diet and lifestyle. Dietary intervention is unlikely to lead to undesirable effects and complications. The only side effects of the test may result from venous blood collection, such as bruising and feeling weak.
Where is the study run from?
Jagiellonian University Medical College (Poland)
When is the study starting and how long is it expected to run for?
From September 2018 to December 2021
Who is funding the study?
The European Union’s Horizon 2020 research and innovation programme (Belgium)
Who is the main contact?
Prof. Malgorzata Malczewska-Malec
The effect of personalized nutritional advice based on weight loss and health status of subjects with abdominal obesity: empowering consumers to prevent diet-related diseases
Personalized dietary advice based on omics science and Preventomics software is more effective at reducing weight and improving metabolic health status than general dietary recommendations in people with abdominal obesity.
Approved 28/03/2019, Bioethics Committee of the Jagiellonian University (ul. Grzegórzecka 20, 31-531 Kraków, Poland; +48 12 433 27 39; firstname.lastname@example.org), ref: 1072.6120.85.2019
Single-centre interventional, single-blinded randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
See additional files
Randomisation will take place once anthropometry is completed using an independent online computerized randomisation system by a member of the study team. Randomisation will be conducted at the level of the individual and will be stratified by sex, age, and waist circumference. Volunteers will be randomly allocated to one of the three groups:
1. Control group, in which volunteers will receive general advice from a dietitian about how to improve their diet
2. Personalised nutrition group, in which participants will use the PREVENTOMICS’ mobile application alongside a dietitian to receive a personalised diet plan through MetaDieta mobile application
3. Personalised plan group, in which, in addition to advice from the dietitian and a personalised diet through the use MetaDieta app and PREVENTOMICS’ app, will also receive prompts to help change food and lifestyle choices
Each intervention will last for 4 months. At the start and at the end of the intervention, subjects will visit GP for health status screening, anthropometric measurements, and blood, urine, saliva, and faeces sample collection. In the collected material, analyses of genome, metabolome, and microbiome will be performed.
Primary outcome measure
1. Waist circumference will be measured at baseline and 4 months
Secondary outcome measures
1. Classic clinical biomarkers measured using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline and 4 months
2. Metabolomics biomarkers measured using Nuclear Magnetic Resonance (NMR) and Liquid Chromatography-Mass Spectrometry (LC/MS) at baseline and 4 months
3. Food intake biomarkers measured using Liquid Chromatography-Ion Mobility Spectrometry-Quadrupole Time of Flight Mass Spectrometry (LC-IMS-QToF MS) at baseline and 4 months
4. Microbiome analysis in feaces using Next Generation Sequencing (NCS) at baseline and 4 months
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Aged between 18-65 years
2. Waist circumference >94 cm for men or >80 cm for women
3. BMI between 25-40 in kg/m2
4. Provided written informed consent
Target number of participants
Participant exclusion criteria
2. Severe hyperlipidemia
3. Other endocrine and metabolic diseases
4. Chronic inflammatory states
5. Diseases of the digestive or respiratory systems
6. Chronic kidney disease
7. Cardiovascular disease
8. Alcohol addiction
9. Pregnancy or lactation
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Jagiellonian University Medical College
Department of Clinical Biochemistry Kopernika 15A
Horizon 2020 Framework Programme
EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, H2020
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publications in high-impact peer-reviewed journals.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later stage.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
- ISRCTN46063864_PIS_v1.0_13Jan2020.pdf uploaded 03/12/2020