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| Name | Class |
|---|---|
| SmartepigenetX SRL | UNKNOWN |
| Advanced Nutrigenomics LLC | UNKNOWN |
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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.)
(Original text in Romanian language:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 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). |
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| Group 2 | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrigenetic | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| blood/serum nutrient levels | nutrients as follows:
Each nutrient (having different system of measure) will be considered as a separate outcome. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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healthy adults
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shape Divine SRL | Bucharest | Romania |
Publication of the results
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