Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/10/2020
Date assigned
03/12/2020
Last edited
03/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
m.malczewska-malec@uj.edu.pl

Trial website

https://preventomics.eu/study-personalised-nutritional-advice-weight-loss/

Contact information

Type

Scientific

Primary contact

Prof Małgorzaata Malczewska-Malec

ORCID ID

http://orcid.org/0000-0002-3522-0711

Contact details

Jagiellonian University Medical College
Department of Clinical Biochemistry
15A Kopernika Street
Kraków
31-501
Poland
+48 12 4214006
m.malczewska-malec@uj.edu.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Z/H20/00030

Study information

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

Acronym

Study hypothesis

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

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

Study design

Single-centre interventional, single-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

See additional files

Condition

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

Phase

Drug names

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

13/09/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

264

Participant 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

Recruitment start date

01/11/2020

Recruitment end date

31/08/2021

Locations

Countries of recruitment

Poland

Trial participating centre

Jagiellonian University Medical College
Department of Clinical Biochemistry Kopernika 15A
Kraków
31-501
Poland

Sponsor information

Organisation

Jagiellonian University

Sponsor details

Jagiellonian University Medical College
ul. Św. Anny 12
Krakow
30-006
Poland
+48 12 37 04 341
katarzyna.gubernat@uj.edu.pl

Sponsor type

University/education

Website

https://cm-uj.krakow.pl/index.php/en/index

Funders

Funder type

Government

Funder name

Horizon 2020 Framework Programme

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, H2020

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

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

31/12/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.