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OpenTrials
Completed

NCT Number: NCT05342766

Precision Nutrition

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.)

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Key information

Conditions

Nutrient Deficiency

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shape Divine SRL

Bucharest, Romania

About this study

  • 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).)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adults

Exclusion criteria

  • any pathology

Treatment and study plan

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).

Other names: Standard

Primary outcomes

  1. blood/serum nutrient levels

    Time frame: 3 months

    nutrients as follows:

    • ALA
    • LA
    • A
    • D
    • E
    • K
    • Riboflavina
    • Niacina
    • Folati
    • B12
    • Calciu
    • Magneziu
    • Seleniu
    • Zinc

    Each nutrient (having different system of measure) will be considered as a separate outcome.

Sponsors and collaborators

Lead sponsor

Shape Divine Center SRL

Other

Collaborators

  • Advanced Nutrigenomics LLC
  • SmartepigenetX SRL

Registry information

Official study title

Nutritia de Precizie

Acronym: NP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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