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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People

Conditions
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Obesity, Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Administration of supplements containing methyl-donors


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult intervention<br>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<br>* 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)<br>|
| Placebo Comparator: Adult placebo<br>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<br>* 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)<br>|
| Experimental: Children intervention<br>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<br>* 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)<br>|
| Placebo Comparator: Children Placebo<br>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<br>* 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)<br>|
| No Intervention: Adults genetic assessment<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | HOMA-IR | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrigenetics, medical foods, obesity, children, adults