Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02837367
Status:
UNKNOWN
Last Update Posted:
2018-10-18
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
Sponsor:
University of Medicine and Pharmacy "Victor Babes" Timisoara
Organization:
Study Overview
Official Title:
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NutriGen
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: