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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05342766
Other study ID # 2022-0101-21493351
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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