HyperhomocysteinemiaPERBIO-HCNCT06264570
Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
A study testing B-TMG supplementation and B-SAM supplementation in people with Hyperhomocysteinemia, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperhomocysteinemia
- What is being tested?
- B-TMG supplementation and B-SAM supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteRussia
- Study dates
- 23 Oct 2023to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Increased homocysteine level above 15 µmol/l;
- Increased LDL level >=1.4 mmol/l.;
- Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study;
Who cannot join
- Individual intolerance to the components of the substance;
- Pregnancy or breastfeeding;
- Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year);
- Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
Andrei AV Ponomarenko, MD, +79628316017, dayshadoff@gmail.com
Elena EI Krykova, +79133825952, krukova_ei@cnmt.ru
About this study
Official title: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels, Prospective,Double-blind Randomised Trial.
The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.
- Conditions
- Hyperhomocysteinemia
- Being tested
- B-TMG supplementation, B-SAM supplementation, B-TMG placebo, B-SAM placebo
- Keywords
- Hyperhomocysteinemia, Cardiovascular diseases, Bioactive substances, Genetically-determined approach, Nutrigenomics
- Medical subject headings
- Hyperhomocysteinemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-TMG supplementationDietary supplement
B-TMG supplement (B2 riboflavin, B6 pyroxidine, B9 methylfolate, B12 methylcobalamine, S-adenosylmethionine, Trimethylglycerol (TMG), zinc sulfate) for subjects with normal COMT gene and MTHFR gene polymorphism
B-SAM supplementationDietary supplement
B-SAM supplement (B2 riboflavin, B6 pyroxidine, B9 folic acid, B12 adenosylcobalamin, magnesium, S-adenosylmethionine) for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
B-TMG placeboOther
B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism
B-SAM placeboOther
B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
| Study group | Role | What they receive |
|---|---|---|
| B-TMG experimental group | Experimental | Subjects with normal COMT gene and MTHFR gene polymorphism Receives: Dietary Supplement: B-TMG supplementation |
| B-SAM experimental group | Experimental | Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene Receives: Dietary Supplement: B-SAM supplementation |
| B-TMG placebo group | Placebo comparator | Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm Receives: Other: B-TMG placebo |
| B-SAM placebo group | Placebo comparator | Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene Receives: Other: B-SAM placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.
Measured: 6 months
Secondary outcomes (4)
change in the level of very low density lipoproteins
Measured: 6 months
change of anxiety when using dietary supplements accessed by the Spielberg scale
Measured: 6 months
change of depression when using dietary supplements by the Becks scale
Measured: 6 months
occurrence of major cardiovascular events during follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Oct 2023
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhomocysteinemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264570
- Sponsor's protocol ID
- SW007
- Acronym
- PERBIO-HC
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels, Prospective,Double-blind Randomised Trial.
- ClinicalTrials.gov ID
- NCT06264570
- Acronym / sponsor ID
- PERBIO-HC / SW007
- Conditions
- Hyperhomocysteinemia
- Keywords
- Hyperhomocysteinemia, Cardiovascular diseases, Bioactive substances, Genetically-determined approach, Nutrigenomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B-TMG experimental group | Experimental | Dietary Supplement: B-TMG supplementationSubjects with normal COMT gene and MTHFR gene polymorphism |
| B-SAM experimental group | Experimental | Dietary Supplement: B-SAM supplementationSubjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene |
| B-TMG placebo group | Placebo comparator | Other: B-TMG placeboSubjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm |
| B-SAM placebo group | Placebo comparator | Other: B-SAM placeboSubjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Increased homocysteine level above 15 µmol/l;
- Increased LDL level >=1.4 mmol/l.;
- Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study;
Key exclusion criteria (4 listed)
- Individual intolerance to the components of the substance;
- Pregnancy or breastfeeding;
- Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year);
- Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.
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 |
|---|---|---|
| B-TMG supplementationB-TMG supplement (B2 riboflavin, B6 pyroxidine, B9 methylfolate, B12 methylcobalamine, S-adenosylmethionine, Trimethylglycerol (TMG), zinc sulfate) for subjects with normal COMT gene and MTHFR gene polymorphism | Dietary supplement | B-TMG experimental group |
| B-SAM supplementationB-SAM supplement (B2 riboflavin, B6 pyroxidine, B9 folic acid, B12 adenosylcobalamin, magnesium, S-adenosylmethionine) for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene | Dietary supplement | B-SAM experimental group |
| B-TMG placeboB-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism | Other | B-TMG placebo group |
| B-SAM placeboB-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene | Other | B-SAM placebo group |
Primary outcome
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.
Time frame: 6 months
4 secondary outcomes
change in the level of very low density lipoproteins
Time frame: 6 months
change of anxiety when using dietary supplements accessed by the Spielberg scale
Time frame: 6 months
change of depression when using dietary supplements by the Becks scale
Time frame: 6 months
occurrence of major cardiovascular events during follow-up
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-TMG supplementation and B-SAM supplementation in people with Hyperhomocysteinemia, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Jun 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. (time frame: 6 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 8 Jun 2025.