Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences

Last updated on July 2021

Recruitment

Recruitment Status: Active, not recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Metabolic Syndrome
Obesity
Overweight

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Eurecat will grant Simple feast and ONMI access to users' profile via PREVENTOMICS Platform in order to know which group the subject is assigned to and intervene accordingly. The profile includes the assigned group/cluster along with nutritional recommendations of each subject. 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals and recipes from Simple Feast. The control group (50 subjects) will receive meals based on general dietary recommendations whereas the meals of the personalized plan group (50 subjects) are personalized based on an analysis of their metabolic biomarkers, genetics, preferences, health status, and lifestyle habits. In addition, ONMI will deliver a personally tailored and actionable behavior change program (Do-Omics) to the personalized plan group while the control group will receive general advice.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Eligible participants will be randomly allocated to either intervention group (personalized plan) or control group prior to commencement of the trial. The allocation will be computer generated, and stratified by metabolic clusters (oxidative stress; inflammation; carbohydrate metabolism; lipid metabolism; microbiota-generated metabolites) in a 1:1 randomization between control and intervention groups. The person responsible for generating the code will not take part in the inclusion and examination of study participants. Study staff at UCPH and participants will be blinded to the treatment group and analyses of results will be performed in a blinded fashion. Moreover, the statistical analyses of the main outcome variable will be done without breaking the code for the intervention treatment, before the primary analyses are finalized.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 65 years
Gender: Both males and females

Description

PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan. To demonstrate the potential for personalization of such platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity. The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast. The control group (n=50) will receive meals based on general dietary recommendations of macronutrient composition, whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers that will help reduce excess body fat. (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages. Our hypothesis is that personalized meal/plan delivery through the PREVENTOMICS platform integrated in e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.

Tracking Information

NCT #

NCT04590989

Collaborators

Fundació Eurecat
Simple Feast
Alimentómica
University of Parma
ONMI

Investigators

Principal Investigator: Mads F Hjorth, PhD University of Copenhagen