Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.

NCT06264570 | Recruiting

• 1 other identifier: SW007
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Hyperhomocysteinemia; Cardiovascular diseases; Bioactive substances; Genetically-determined approach; Nutrigenomics

Outcome Measures

Primary Outcomes (1)

• Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.

  6 months

Secondary Outcomes (4)

• change in the level of very low density lipoproteins

  6 months

• change of anxiety when using dietary supplements accessed by the Spielberg scale

  6 months

• change of depression when using dietary supplements by the Becks scale

  6 months

• occurrence of major cardiovascular events during follow-up

  6 months

Study Arms (4)

B-TMG experimental group

EXPERIMENTAL

Subjects with normal COMT gene and MTHFR gene polymorphism

Dietary Supplement: B-TMG supplementation

B-SAM experimental group

EXPERIMENTAL

Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Dietary Supplement: B-SAM supplementation

B-TMG placebo group

PLACEBO COMPARATOR

Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm

Other: B-TMG placebo

B-SAM placebo group

PLACEBO COMPARATOR

Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

Other: B-SAM placebo

Interventions

B-TMG supplementation DIETARY_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-TMG experimental group

B-SAM supplementation DIETARY_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-SAM experimental group

B-TMG placebo OTHER

B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism

B-TMG placebo group

B-SAM placebo OTHER

B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

B-SAM placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Individual intolerance to the components of the substance;
• Pregnancy or breastfeeding;
• Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year);

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

RECRUITING

MeSH Terms

Conditions

Hyperhomocysteinemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: October 23, 2023
• Primary Completion: December 15, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-03

Locations

RU (1)