Nutrient DeficiencyNPNCT05342766
Precision Nutrition
An observational study of Nutrient Deficiency, run by Shape Divine Center SRL at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- Nutrigenetic
- How many people
- 46 participants
- Where
- 1 siteRomania
- Study dates
- 1 May 2022to 1 Oct 2023
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy adults
Who may be able to join
- healthy adults
Who cannot join
- any pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.)
Read the detailed description
- Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes;
- Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure;
- Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes;
- (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach). (Original text in Romanian language:
- Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice;
- Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice.
- 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.
- (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)
- Conditions
- Nutrient Deficiency
- Being tested
- Nutrigenetic
- Keywords
- Genotypes, Nutrient intakes, Nutrient plasma levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrigeneticDietary supplement
Also called Standard
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Nutrigenetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2022
- Primary completion31 Jan 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Shape Divine Center SRL
- Sponsor type
- University, hospital or other
- Collaborators
- SmartepigenetX SRL, Advanced Nutrigenomics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342766
- Sponsor's protocol ID
- 2022-0101-21493351
- Acronym
- NP
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritia de Precizie
- ClinicalTrials.gov ID
- NCT05342766
- Acronym / sponsor ID
- NP / 2022-0101-21493351
- Conditions
- Nutrient Deficiency
- Keywords
- Genotypes, Nutrient intakes, Nutrient plasma levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shape Divine Center SRLUniversity, hospital or other
- Collaborators
- SmartepigenetX SRL, Advanced Nutrigenomics LLC
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes;
- Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure;
- Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes;
- (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach). (Original text in Romanian language:
- Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice;
- Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice.
- 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.
- (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Dietary Supplement: NutrigeneticHalf 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 | – | Dietary Supplement: NutrigeneticHalf 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (1 listed)
- any pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutrigeneticAlso: StandardEach grup will receive two interventions ("Nutrigenetic" and "Standard"), in a cross-over design (3 months each), spaced by a wash-out period (3 months). | Dietary supplement | Group 1, Group 2 |
Primary outcome
blood/serum nutrient levels
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No. Publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrient Deficiency, run by Shape Divine Center SRL at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood/serum nutrient levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.