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

• ClinicalTrials.gov Identifier: NCT02837367
• Recruitment Status: Unknown
• First Posted: July 19, 2016
• Last Update Posted: October 18, 2018
• Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
• Collaborator: Romania:The National Authority for Scientific Research
• Information provided by (Responsible Party): Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Dyslipidemia	Dietary Supplement: Administration of supplements containing methyl-donors	Not Applicable

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Lipid profile [ Time Frame: 3 years ]
   HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG)

Secondary Outcome Measures :

1. Insulin sensitivity [ Time Frame: 3 years ]
   HOMA-IR

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Maria Puiu, MD, PhD; 0040730118152; maria_puiu@umft.ro

Locations

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

Sponsors and Collaborators

University of Medicine and Pharmacy "Victor Babes" Timisoara

Romania:The National Authority for Scientific Research

Investigators

• Principal Investigator: Mihai Niculescu, MD, PhD; University of Medicine and Pharmacy "Victor Babes" Timisoara

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Șerban CL, Sima A, Hogea CM, Chiriță-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). pii: E3036. doi: 10.3390/ijerph16173036.

• 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
• Last Update Posted: October 18, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara:

nutrigenetics; medical foods; obesity; children; adults

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases