NCT02837367

Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara · Academic / Other
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.

Detailed description

NutriGen project specific aim 1. Establishing a genetic signature model, involved in the donation of methyl groups and unsaturated omega-6/3 fatty acids metabolism, with a high predictive value for classification of dyslipidemia and insulin resistance in obese subjects. 1. Establishing a genetic signature model in obese adults with dyslipidemia. 2. Establishing a genetic signature model in obese children with insulin resistance. c. Establishing a correlation between blood/plasma concentrations of the relevant metabolites, genetic signatures and dyslipidemia profile of adults, and respectively a profile for insulin resistance in obese children. NutriGen project specific aim 2. Determining the efficacy of a dietary food specific treatment, which is also correlated with a genetic signature (nutrigenomics), based on the correlations defined in objective 1: 1. Implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments; 2. Implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.

Conditions

• Obesity
• Dyslipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Administration of supplements containing methyl-donors	Administration of supplements containing methyl-donors: betaine, 5-MTHF (L-5-methyltetrahydrofolate), Vitamin B12, choline bitartrate, ALA (alfa-linolenic acid), EPA (eicosapentaenoic acid), DHA(docosahexaenoic acid)

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-07-19
• Last updated: 2018-10-18

Locations

2 sites across 1 country: Romania