Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences
Condition: Overweight; Obesity; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark,
      is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool
      created to deliver personalized meals and dietary advices is able to produce more favorable
      health effects than meals based on general dietary recommendations in overweight subjects
      with elevated waist circumference.
    

Detailed 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 the 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 following the national guidelines of macronutrient
      composition. The control group (n=50) will receive meals based on general dietary
      recommendations whereas the meals of the second group (n=50) are personalized based on
      metabolic biomarkers (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 delivery of personalized meal/plan through the PREVENTOMICS platform
      integrated with 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.
    

Intervention name(s): Personalized Nutrition Plan; Non-Personalized Nutrition Plan
Intervention type(s): Other; Other
Intervention description(s): Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations.
Personalized behavioral change program via electronic push notifications by ONMI; Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized.
Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Nutrigenomics; Nutrigenetics; Metabolomics; Microbiome; Precision nutrition; Personalized nutrition; Weight management; Body weight; Obesity