Precision Nutrition (NP)

Nutritia de Precizie

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.)

Study Overview

• Status: Completed
• Conditions: Nutrient Deficiency
• Intervention / Treatment: Dietary supplement: Nutrigenetic

Detailed 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).)

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Shape Divine SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

healthy adults

Description

Inclusion Criteria:

• healthy adults

Exclusion Criteria:

• any pathology

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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).; Other Names: Standard
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).	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).; Other Names: Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood/serum nutrient levels	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.	3 months

Collaborators and Investigators

• Sponsor: Shape Divine Center SRL
• Collaborators: SmartepigenetX SRL; Advanced Nutrigenomics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Genotypes; Nutrient intakes; Nutrient plasma levels
• Other Study ID Numbers: 2022-0101-21493351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publication of the results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No