Precision Nutrition

Study Overview
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Brief Summary
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Determine the relationship between relevant genotypes and nutrient plasma levels, with the aim to normalize such levels using a nutritional intervention. (Original text in Romanian language: Caracterizarea precisa a relatiei dintre variatiile genetice si nivelul de nutrienti din sange/plasma/ser, in scopul de a defini modul in care aportul alimentar poate normaliza aceste nivele.)

Detailed Description
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Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes; Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure; Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes; (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach). (Original text in Romanian language: Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice; Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice. Gasirea unor formule de predictie in care variabilele independente (variatii genetice si combinatii ale acestora) sa defineasca necesarul de nutrienti pentru a normaliza valorile sangvine ale acestor nutrienti. (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)

Official Title
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Nutritia de Precizie

Conditions
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Nutrient Deficiency

Intervention / Treatment
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* Dietary Supplement: Nutrigenetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults Exclusion Criteria: any pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Half of participants (healthy M and F, no children), randomly assigned. Group assignment will balance sex distribution. Nutrigenetic testing will be performed prior to intervention. Participants will work with a registered dietician, who will assess their current nutrient intakes and corresponding nutrient plasma values (T0). Target nutrient intakes will be determined based on nutrigenetic assessment. Participants undergo a nutrition intervention (first 3 months, Intervention 1), in which the difference between actual intakes and nutrigenetically-recommended intakes will be provided using supplements. At the end of Intervention 1 (T1), nutrient plasma values will be measured. After a wash-out period (3 months, no supplementation), nutrient plasma levels will be measured (T2), and a second intervention (3 months, Intervention 2) will consist of supplements administered according to EFSA recommended levels. At the end of Intervention 2, plasma nutrient levels will be measured (T3). | Dietary Supplement: Nutrigenetic<br>* Each grup will receive two interventions (Nutrigenetic and Standard), in a cross-over design (3 months each), spaced by a wash-out period (3 months).<br>* Other names: Standard;|
| Group 2<br>Half of participants (healthy M and F, no children), randomly assigned. Group assignment will balance sex distribution. Nutrigenetic testing will be performed prior to intervention. Participants will work with a registered dietician, who will assess their current nutrient intakes and corresponding nutrient plasma values (T0). Target nutrient intakes will be determined based on nutrigenetic assessment. Participants undergo a nutrition intervention (first 3 months, Intervention 1), in which the difference between actual intakes and EFSA-recommended intakes will be provided using supplements. At the end of Intervention 1 (T1), nutrient plasma values are measured. After a wash-out period (3 months, no supplementation), nutrient plasma levels will be measured (T2), and a second intervention (3 months, Intervention 2) will consist of supplements administered according to targets recommended by nutrigenetic testing. At the end of Intervention 2, plasma nutrient levels will be measured (T3). | Dietary Supplement: Nutrigenetic<br>* Each grup will receive two interventions (Nutrigenetic and Standard), in a cross-over design (3 months each), spaced by a wash-out period (3 months).<br>* Other names: Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood/serum nutrient levels | nutrients as follows:o ALA LA A D E K Riboflavina Niacina Folati B12 Calciu Magneziu Seleniu Zinc | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotypes, Nutrient intakes, Nutrient plasma levels