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| Name | Class |
|---|---|
| Romania:The National Authority for Scientific Research | UNKNOWN |
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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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult intervention | Experimental | The intervention will consist Administration of supplements containing methyl-donors (as capsules) containing: 2 g betaine, 800 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 1000 ug (micrograms) Vitamin B12, 500 mg choline bitartrate, 1 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 280 mg DHA (docosahexaenoic acid). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
|
| Adult placebo | Placebo Comparator | The intervention will consist of the Administration of supplements containing methyl-donors (as capsules) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
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| Children intervention | Experimental | The intervention will consist of the Administration of supplements containing methyl-donors (as syrup) containing: 1 g betaine, 400 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 500 ug (micrograms) Vitamin B12, 250 mg choline bitartrate, 0.5 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 140 mg DHA (docosahexaenoic acid). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of supplements containing methyl-donors | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | HOMA-IR | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Puiu, MD, PhD | Contact | 0040730118152 | maria_puiu@umft.ro |
| Name | Affiliation | Role |
|---|---|---|
| Mihai Niculescu, MD, PhD | University of Medicine and Pharmacy "Victor Babes" Timisoara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica II Pediatrie Bega | Recruiting | Timișoara | Timiș County | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23292069 | Background | 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. | |
| 33239899 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Children Placebo | Placebo Comparator | The intervention will consist of Administration of supplements containing methyl-donors (as syrup) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
|
| Adults genetic assessment | No Intervention | Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in adult people with obesity. |
| Children genetic assessment | No Intervention | Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in children with obesity. |
|
| Spitalul Judetean Timisoara; Centrul de Diabet | Recruiting | Timișoara | Timiș County | Romania |
|
| 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. |
| 31443343 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |