Precision Nutrition

Completed

• Conditions: Nutrient Deficiency
• Interventions: Dietary Supplement: Nutrigenetic

• Registration Number: NCT05342766
• Lead Sponsor: Shape Divine Center SRL

Brief 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.)

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 Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-25
• Study Start: 2022-05-01
• Primary Completion: 2023-01-31
• Study Completion: 2023-10-01
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• healthy adults

Exclusion Criteria

• any pathology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Nutrigenetic	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).
Group 2	Nutrigenetic	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).

Primary Outcome Measures

Name	Time	Method
blood/serum nutrient levels	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.

Trial Locations

Locations (1)

Shape Divine SRL; 🇷🇴 Bucharest, Romania