Precision Nutrition

NCT05342766 | Completed

• 1 other identifier: 2022-0101-21493351
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.)

Conditions

Nutrient Deficiency

Keywords

Genotypes; Nutrient intakes; Nutrient plasma levels

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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).

Also known as: Standard

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy adults

You may qualify if:

• healthy adults

You may not qualify if:

• any pathology

Sponsors & Collaborators

• Shape Divine Center SRL: lead
• SmartepigenetX SRL: collaborator
• Advanced Nutrigenomics LLC: collaborator

Study Sites (1)

Shape Divine SRL

Bucharest, Romania

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 25, 2022
• Study Start: May 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: October 1, 2023
• Last Updated: May 15, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)