NCT04590989

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

PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity
• Metabolic Syndrome

Interventions

Type	Name	Description
OTHER	Personalized Nutrition Plan	* 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
OTHER	Non-Personalized Nutrition Plan	* 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).

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-06-14
• Completion: 2021-06-14
• First posted: 2020-10-19
• Last updated: 2021-07-15

Locations

1 site across 1 country: Denmark