Personalised nutritional advice to aid weight loss
| ISRCTN | ISRCTN46063864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46063864 |
| Secondary identifying numbers | Z/H20/00030 |
- Submission date
- 19/10/2020
- Registration date
- 03/12/2020
- Last edited
- 04/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 April 2022
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
m.malczewska-malec@uj.edu.pl
Contact information
Scientific
Jagiellonian University Medical College
Department of Clinical Biochemistry
15A Kopernika Street
Kraków
31-501
Poland
 ORCID ID |
0000-0002-3522-0711 |
|---|---|
| Phone | +48 12 4214006 |
| m.malczewska-malec@uj.edu.pl |
Study information
| Study design | Single-centre interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | ISRCTN46063864_PIS_v1.0_13Jan2020.pdf |
| Scientific title | 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 |
| Study objectives | 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. |
| Ethics approval(s) | Approved 28/03/2019, Bioethics Committee of the Jagiellonian University (ul. Grzegórzecka 20, 31-531 Kraków, Poland; +48 12 433 27 39; kbet@cm-uj.krakow.pl), ref: 1072.6120.85.2019 |
| Health condition(s) or problem(s) studied | Abdominal obesity |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| 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 study start date | 13/09/2018 |
| Completion date | 30/04/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 264 |
| Total final enrolment | 265 |
| Key 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 |
| Key exclusion criteria | 1. Diabetes 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 |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- Poland
Study participating centre
Kopernika 15A
Kraków
31-501
Poland
Sponsor information
University/education
Jagiellonian University Medical College
ul. Św. Anny 12
Krakow
30-006
Poland
| Phone | +48 12 37 04 341 |
|---|---|
| katarzyna.gubernat@uj.edu.pl | |
| Website | https://cm-uj.krakow.pl/index.php/en/index |
"ROR" |
https://ror.org/03bqmcz70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- 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, Horizont 2020, Horizonte 2020, Orizzonte 2020, Horyzont 2020, Horizon 2020 Framework Programme (H2020), H2020
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals. |
| IPD sharing plan | All the data is stored in GDPR-compliant servers at EURECAT (leading Project partner in Barcelona) and it is only available to consortium members in a restrictive mode. It is planned to create a common database with the data from the different partners. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.0 | 13/01/2020 | 03/12/2020 | No | Yes |
| Protocol file | 28/09/2022 | No | No | ||
| Basic results | 19/06/2023 | No | No | ||
| Other publications | Cost-effectiveness | 01/06/2025 | 04/06/2025 | Yes | No |
Additional files
Editorial Notes
04/06/2025: Publication reference added.
19/06/2023: The basic results have been uploaded as an additional file.
05/10/2022: IPD sharing statement added.
28/09/2022: Uploaded protocol (not peer reviewed).
30/12/2021: The overall trial end date was changed from 31/12/2021 to 30/04/2022. The total final enrolment number was added.
03/12/2020: The participant information sheet was uploaded as an additional file.
11/11/2020: Trial’s existence confirmed by the Bioethics Committee of the Jagiellonian University.
