Precision Nutrition

Nutrient Deficiency Clinical Trial

— NP  

Official title:

Nutritia de Precizie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342766
• Other study ID #: 2022-0101-21493351
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2022
• Source: Shape Divine Center SRL
• Contact: Daniela Stoian, PhD
• Phone: +40788406232
• Email: dana.stoian[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.)

Description:

1. Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes;

2. Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure;

3. Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes;

4. (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach).

(Original text in Romanian language:

1. Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice;

2. Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice.

3. 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.

4. (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy adults

Exclusion Criteria:

• any pathology

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

Dietary Supplement:
• Nutrigenetic
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).

Locations

Country	Name	City	State
Romania	Shape Divine SRL	Bucharest

Sponsors (3)

Lead Sponsor	Collaborator
Shape Divine Center SRL	Advanced Nutrigenomics LLC, SmartepigenetX SRL

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood/serum nutrient levels	nutrients as follows:o ALA; LA; A; D; E; K; Riboflavina; Niacina; Folati; B12; Calciu; Magneziu; Seleniu; Zinc	3 months