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

Obesity Clinical Trial

— NutriGen  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02837367
• Other study ID #: UniversityMedPharmaVBT
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

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