Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837367
Acronym
NutriGen
Enrollment
600
Registered
2016-07-19
Start date
2016-09-30
Completion date
2019-09-30
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Obesity

Keywords

nutrigenetics, medical foods, obesity, children, adults

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.

Interventions

DIETARY_SUPPLEMENTAdministration 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)

Sponsors

Romania:The National Authority for Scientific Research
CollaboratorUNKNOWN
University of Medicine and Pharmacy Victor Babes Timisoara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Adults: between 18 and 70 years old; obesity present as defined by body mass index (BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe). * Children: age between 7 and 18 years old; BMI \>+2SD WHO reference

Exclusion criteria

* Adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using AUDIT-C. * Children: the above

Design outcomes

Primary

MeasureTime frameDescription
Lipid profile3 yearsHDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG)

Secondary

MeasureTime frameDescription
Insulin sensitivity3 yearsHOMA-IR

Countries

Romania

Contacts

Primary ContactMaria Puiu, MD, PhD
maria_puiu@umft.ro0040730118152

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026