Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People (NutriGen)
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ClinicalTrials.gov Identifier: NCT02837367 |
Recruitment Status : Unknown
Verified October 2018 by Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara.
Recruitment status was: Recruiting
First Posted : July 19, 2016
Last Update Posted : October 18, 2018
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Condition or disease | Intervention/treatment | Phase |
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Obesity Dyslipidemia | Dietary Supplement: Administration of supplements containing methyl-donors | Not Applicable |
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.
- Establishing a genetic signature model in obese adults with dyslipidemia.
- 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:
- Implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments;
- Implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People |
Study Start Date : | September 2016 |
Estimated Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | September 2019 |
Arm | Intervention/treatment |
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Experimental: Adult intervention
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 |
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) |
Placebo Comparator: Adult placebo
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 |
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) |
Experimental: Children intervention
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 |
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) |
Placebo Comparator: Children Placebo
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 |
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) |
No Intervention: Adults genetic assessment
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.
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No Intervention: Children genetic assessment
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.
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- Lipid profile [ Time Frame: 3 years ]HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG)
- Insulin sensitivity [ Time Frame: 3 years ]HOMA-IR

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Ages Eligible for Study: | 7 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837367
Contact: Maria Puiu, MD, PhD | 0040730118152 | maria_puiu@umft.ro |
Romania | |
Clinica II Pediatrie Bega | Recruiting |
Timisoara, Timis, Romania | |
Contact: Iulian Velea, MD, PhD 0771522781 ivelea@umft.ro | |
Spitalul Judetean Timisoara; Centrul de Diabet | Recruiting |
Timisoara, Timis, Romania | |
Contact: Alexandra Sima, MD, PhD 0770727169 alexa_moisuc@yahoo.com |
Principal Investigator: | Mihai Niculescu, MD, PhD | University of Medicine and Pharmacy "Victor Babes" Timisoara |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Maria Puiu, Professor Dr Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara |
ClinicalTrials.gov Identifier: | NCT02837367 |
Other Study ID Numbers: |
UniversityMedPharmaVBT |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | October 18, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
nutrigenetics medical foods obesity children adults |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |