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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 : Recruiting
First Posted : July 19, 2016
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Romania:The National Authority for Scientific Research
Information provided by (Responsible Party):
Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara

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.

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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
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.



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



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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
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.

Information from the National Library of Medicine

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


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

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

Publications:
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Responsible Party: Maria Puiu, Professor Dr Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara
ClinicalTrials.gov Identifier: NCT02837367     History of Changes
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

Keywords provided by Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara:
nutrigenetics
medical foods
obesity
children
adults

Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin B 12
Tetrahydrofolates
Choline
Betaine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents