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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02837367
Other study ID # UniversityMedPharmaVBT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2019

Study information

Verified date October 2018
Source University of Medicine and Pharmacy "Victor Babes" Timisoara
Contact Maria Puiu, MD, PhD
Phone 0040730118152
Email maria_puiu@umft.ro
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 70 Years
Eligibility 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 exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes (Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Romania Clinica II Pediatrie Bega Timisoara Timis
Romania Spitalul Judetean Timisoara; Centrul de Diabet Timisoara Timis

Sponsors (2)

Lead Sponsor Collaborator
University of Medicine and Pharmacy "Victor Babes" Timisoara Romania:The National Authority for Scientific Research

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Corbin KD, Abdelmalek MF, Spencer MD, da Costa KA, Galanko JA, Sha W, Suzuki A, Guy CD, Cardona DM, Torquati A, Diehl AM, Zeisel SH. Genetic signatures in choline and 1-carbon metabolism are associated with the severity of hepatic steatosis. FASEB J. 2013 Apr;27(4):1674-89. doi: 10.1096/fj.12-219097. Epub 2013 Jan 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lipid profile HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG) 3 years
Secondary Insulin sensitivity HOMA-IR 3 years
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