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

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

Interventions

DIETARY_SUPPLEMENT

B-TMG supplementation

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

DIETARY_SUPPLEMENT

B-SAM supplementation

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

OTHER

B-TMG placebo

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

OTHER

B-SAM placebo

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

Sponsors & Collaborators

• Center of New Medical Technologies

  collaborator OTHER

• S.LAB (SOLOWAYS)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-23

Primary Completion

2025-12-15

Completion

2026-10-30

Countries

• Russia

Study Locations