ObesityNutriGenNCT02837367
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
A study testing Administration of supplements containing methyl-donors in people with Obesity and Dyslipidemia, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 2 sites in Romania.
Trial summary
The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals. Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Obesity, Dyslipidemia
- What is being tested?
- Administration of supplements containing methyl-donors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesRomania
- Study dates
- Sep 2016to Sep 2019
- Phase
- Interventional
- 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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults: between 18 and 70 years old; obesity present as defined by body mass index (BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe).
- Children: age between 7 and 18 years old; BMI >+2SD WHO reference
Who cannot join
- Adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using AUDIT-C.
- Children: the above exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes (Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites, 2 recruiting
- Recruiting
Clinica II Pediatrie Bega
Timișoara, Timiș County
Iulian Velea, MD, PhD, 0771522781, ivelea@umft.ro
- Recruiting
Spitalul Judetean Timisoara; Centrul de Diabet
Timișoara, Timiș County
Alexandra Sima, MD, PhD, 0770727169, alexa_moisuc@yahoo.com
About this study
The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.
Read the detailed description
NutriGen project specific aim 1. Establishing a genetic signature model, involved in the donation of methyl groups and unsaturated omega-6/3 fatty acids metabolism, with a high predictive value for classification of dyslipidemia and insulin resistance in obese subjects.
- Establishing a genetic signature model in obese adults with dyslipidemia.
- Establishing a genetic signature model in obese children with insulin resistance. c. Establishing a correlation between blood/plasma concentrations of the relevant metabolites, genetic signatures and dyslipidemia profile of adults, and respectively a profile for insulin resistance in obese children.
NutriGen project specific aim 2. Determining the efficacy of a dietary food specific treatment, which is also correlated with a genetic signature (nutrigenomics), based on the correlations defined in objective 1:
- Implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments;
- Implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.
- Conditions
- Obesity, Dyslipidemia
- Being tested
- Administration of supplements containing methyl-donors
- Keywords
- nutrigenetics, medical foods, obesity, children, adults
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of supplements containing methyl-donorsDietary supplement
Administration of supplements containing methyl-donors: betaine, 5-MTHF (L-5-methyltetrahydrofolate), Vitamin B12, choline bitartrate, ALA (alfa-linolenic acid), EPA (eicosapentaenoic acid), DHA(docosahexaenoic acid)
| Study group | Role | What they receive |
|---|---|---|
| Adult intervention | Experimental | The intervention will consist Administration of supplements containing methyl-donors (as capsules) containing: 2 g betaine, 800 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 1000 ug (micrograms) Vitamin B12, 500 mg choline bitartrate, 1 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 280 mg DHA (docosahexaenoic acid).
Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months Receives: Dietary Supplement: Administration of supplements containing methyl-donors |
| Adult placebo | Placebo comparator | The intervention will consist of the Administration of supplements containing methyl-donors (as capsules) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g).
Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months Receives: Dietary Supplement: Administration of supplements containing methyl-donors |
| Children intervention | Experimental | The intervention will consist of the Administration of supplements containing methyl-donors (as syrup) containing: 1 g betaine, 400 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 500 ug (micrograms) Vitamin B12, 250 mg choline bitartrate, 0.5 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 140 mg DHA (docosahexaenoic acid).
Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months Receives: Dietary Supplement: Administration of supplements containing methyl-donors |
| Children Placebo | Placebo comparator | The intervention will consist of Administration of supplements containing methyl-donors (as syrup) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g).
Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months Receives: Dietary Supplement: Administration of supplements containing methyl-donors |
| Adults genetic assessment | No intervention | Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in adult people with obesity. |
| Children genetic assessment | No intervention | Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in children with obesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG)
Measured: 3 years
Secondary outcomes (1)
Insulin sensitivity
HOMA-IR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Collaborators
- Romania:The National Authority for Scientific Research
- Responsible party
- Principal investigator, Maria Puiu, University of Medicine and Pharmacy "Victor Babes" Timisoara
- Investigators
- Mihai Niculescu, MD, PhD, Principal investigator, University of Medicine and Pharmacy "Victor Babes" Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837367
- Sponsor's protocol ID
- UniversityMedPharmaVBT
- Acronym
- NutriGen
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Corbin KD, Abdelmalek MF, Spencer MD, da Costa KA, Galanko JA, Sha W, Suzuki A, Guy CD, Cardona DM, Torquati A, Diehl AM, Zeisel SH. Genetic signatures in choline and 1-carbon metabolism are associated with the severity of hepatic steatosis. FASEB J. 2013 Apr;27(4):1674-89. doi: 10.1096/fj.12-219097. Epub 2013 Jan 4.
PubMed 23292069Chirita-Emandi A, Serban CL, Paul C, Andreescu N, Velea I, Mihailescu A, Serafim V, Tiugan DA, Tutac P, Zimbru C, Puiu M, Niculescu MD. CHDH-PNPLA3 Gene-Gene Interactions Predict Insulin Resistance in Children with Obesity. Diabetes Metab Syndr Obes. 2020 Nov 19;13:4483-4494. doi: 10.2147/DMSO.S277268. eCollection 2020.
PubMed 33239899Serban CL, Sima A, Hogea CM, Chirita-Emandi A, Perva IT, Vlad A, Albai A, Nicolae G, Putnoky S, Timar R, Niculescu MD, Puiu M. Assessment of Nutritional Intakes in Individuals with Obesity under Medical Supervision. A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Aug 22;16(17):3036. doi: 10.3390/ijerph16173036.
PubMed 31443343
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
- ClinicalTrials.gov ID
- NCT02837367
- Acronym / sponsor ID
- NutriGen / UniversityMedPharmaVBT
- Conditions
- Obesity, Dyslipidemia
- Keywords
- nutrigenetics, medical foods, obesity, children, adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Collaborators
- Romania:The National Authority for Scientific Research
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.
Detailed description
NutriGen project specific aim 1. Establishing a genetic signature model, involved in the donation of methyl groups and unsaturated omega-6/3 fatty acids metabolism, with a high predictive value for classification of dyslipidemia and insulin resistance in obese subjects.
- Establishing a genetic signature model in obese adults with dyslipidemia.
- Establishing a genetic signature model in obese children with insulin resistance. c. Establishing a correlation between blood/plasma concentrations of the relevant metabolites, genetic signatures and dyslipidemia profile of adults, and respectively a profile for insulin resistance in obese children.
NutriGen project specific aim 2. Determining the efficacy of a dietary food specific treatment, which is also correlated with a genetic signature (nutrigenomics), based on the correlations defined in objective 1:
- Implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments;
- Implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adult intervention | Experimental | Dietary Supplement: Administration of supplements containing methyl-donorsThe intervention will consist Administration of supplements containing methyl-donors (as capsules) containing: 2 g betaine, 800 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 1000 ug (micrograms) Vitamin B12, 500 mg choline bitartrate, 1 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 280 mg DHA (docosahexaenoic acid). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
| Adult placebo | Placebo comparator | Dietary Supplement: Administration of supplements containing methyl-donorsThe intervention will consist of the Administration of supplements containing methyl-donors (as capsules) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
| Children intervention | Experimental | Dietary Supplement: Administration of supplements containing methyl-donorsThe intervention will consist of the Administration of supplements containing methyl-donors (as syrup) containing: 1 g betaine, 400 ug (micrograms) 5-MTHF (L-5-methyltetrahydrofolate) + 500 ug (micrograms) Vitamin B12, 250 mg choline bitartrate, 0.5 g ALA (alfa-linolenic acid), 700 mg EPA (eicosapentaenoic acid), 140 mg DHA (docosahexaenoic acid). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
| Children Placebo | Placebo comparator | Dietary Supplement: Administration of supplements containing methyl-donorsThe intervention will consist of Administration of supplements containing methyl-donors (as syrup) containing inactive ingredients with low glycemic index (usually starch-based), and one capsule containing corn oil (1 g). Every week the participants will receive a weekly amount of supplements, in opaque pharmaceutical-grade plastic bottles, adequately coded. Participants will be instructed to consume the daily amounts in 2-3 administrations, immediately after a meal,for a duration of 3 months |
| Adults genetic assessment | No intervention | –Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in adult people with obesity. |
| Children genetic assessment | No intervention | –Establishing a genetic signature model in the 1-carbon and omega-6/3 fatty acids metabolic pathways, with high predictive value for dyslipidemia and insulin resistance classification in children with obesity. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adults: between 18 and 70 years old; obesity present as defined by body mass index (BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe).
- Children: age between 7 and 18 years old; BMI >+2SD WHO reference
Key exclusion criteria (2 listed)
- Adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using AUDIT-C.
- Children: the above exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes (Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.
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 |
|---|---|---|
| Administration of supplements containing methyl-donorsAdministration of supplements containing methyl-donors: betaine, 5-MTHF (L-5-methyltetrahydrofolate), Vitamin B12, choline bitartrate, ALA (alfa-linolenic acid), EPA (eicosapentaenoic acid), DHA(docosahexaenoic acid) | Dietary supplement | Adult intervention, Adult placebo, Children Placebo, Children intervention |
Primary outcome
Lipid profile
Time frame: 3 years
HDL-cholesterol (HDLc), LDL-cholesterol (LDLc), triglycerides (TG)
1 secondary outcome
Insulin sensitivity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Background: PubMed 23292069Corbin KD, Abdelmalek MF, Spencer MD, da Costa KA, Galanko JA, Sha W, Suzuki A, Guy CD, Cardona DM, Torquati A, Diehl AM, Zeisel SH. Genetic signatures in choline and 1-carbon metabolism are associated with the severity of hepatic steatosis. FASEB J. 2013 Apr;27(4):1674-89. doi: 10.1096/fj.12-219097. Epub 2013 Jan 4.
- Derived from this study: PubMed 33239899Chirita-Emandi A, Serban CL, Paul C, Andreescu N, Velea I, Mihailescu A, Serafim V, Tiugan DA, Tutac P, Zimbru C, Puiu M, Niculescu MD. CHDH-PNPLA3 Gene-Gene Interactions Predict Insulin Resistance in Children with Obesity. Diabetes Metab Syndr Obes. 2020 Nov 19;13:4483-4494. doi: 10.2147/DMSO.S277268. eCollection 2020.
- Derived from this study: PubMed 31443343Serban CL, Sima A, Hogea CM, Chirita-Emandi A, Perva IT, Vlad A, Albai A, Nicolae G, Putnoky S, Timar R, Niculescu MD, Puiu M. Assessment of Nutritional Intakes in Individuals with Obesity under Medical Supervision. A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Aug 22;16(17):3036. doi: 10.3390/ijerph16173036.
- Individual participant dataSharing planned: No
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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.
Mihai Niculescu, MD, PhD principal investigator
University of Medicine and Pharmacy "Victor Babes" Timisoara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of supplements containing methyl-donors in people with Obesity and Dyslipidemia, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 2 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Puiu, MD, PhD (0040730118152, maria_puiu@umft.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837367, which also lists 3 linked publications.
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 18 Oct 2018.