Clinical trial NCT02837367: Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
Official title: Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Dyslipidemia
Keywords: nutrigenetics
medical foods
obesity
children
adults
Lead sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
Sponsor class: OTHER
Collaborators: name: Romania:The National Authority for Scientific Research
First posted: 2016-07-19
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid profile
timeFrame: 3 years
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 3 years
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Clinica II Pediatrie Bega
state: Timis
city: Timisoara
country: Romania
facility: Spitalul Judetean Timisoara; Centrul de Diabet
state: Timis
Study officials:
affiliation: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: Mihai Niculescu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chirita-Emandi A, Serban CL, Paul C, Andreescu N, Velea I, Mihailescu A, Serafim V, Tiugan DA, Tutac P, Zimbru C, Puiu M, Niculescu MD. CHDH-PNPLA3 Gene-Gene Interactions Predict Insulin Resistance in Children with Obesity. Diabetes Metab Syndr Obes. 2020 Nov 19;13:4483-4494. doi: 10.2147/DMSO.S277268. eCollection 2020.
citation: Serban CL, Sima A, Hogea CM, Chirita-Emandi A, Perva IT, Vlad A, Albai A, Nicolae G, Putnoky S, Timar R, Niculescu MD, Puiu M. Assessment of Nutritional Intakes in Individuals with Obesity under Medical Supervision. A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Aug 22;16(17):3036. doi: 10.3390/ijerph16173036.