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.
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;
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.
Parallel
B-TMG supplementation
Dietary supplementB-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 supplementation
Dietary supplementB-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 placebo
Other interventionB-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism
B-SAM placebo
Other interventionB-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.
change in the level of very low density lipoproteins
change of anxiety when using dietary supplements accessed by the Spielberg scale
change of depression when using dietary supplements by the Becks scale
occurrence of major cardiovascular events during follow-up
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S.LAB (SOLOWAYS)
Lead sponsor
Center of New Medical Technologies
Collaborator
