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

University of Medicine and Pharmacy "Victor Babes" Timisoara

Status: Unknown

Conditions: Obesity; Dyslipidemia

Treatments: Dietary Supplement: Administration of supplements containing methyl-donors

Study type: Interventional

Funder types: Other

Identifiers

NCT02837367

UniversityMedPharmaVBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 7 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 6 patient groups, including a placebo group

Adult intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Administration of supplements containing methyl-donors

Adult placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Administration of supplements containing methyl-donors

Children intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Administration of supplements containing methyl-donors

Children Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Administration of supplements containing methyl-donors

Adults genetic assessment

No Intervention group

Description:

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 group

Description:

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.