Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels. (PERBIO-HC)

S.LAB (SOLOWAYS)

Status: Enrolling

Conditions: Hyperhomocysteinemia

Treatments: Dietary Supplement: B-SAM supplementation; Other: B-TMG placebo; Dietary Supplement: B-TMG supplementation; Other: B-SAM placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06264570

SW007

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 4 patient groups, including a placebo group

B-TMG experimental group

Experimental group

Description:

Subjects with normal COMT gene and MTHFR gene polymorphism

Treatment:

Dietary Supplement: B-TMG supplementation

B-SAM experimental group

Experimental group

Description:

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

Treatment:

Dietary Supplement: B-SAM supplementation

B-TMG placebo group

Placebo Comparator group

Description:

Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm

Treatment:

Other: B-TMG placebo

B-SAM placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: B-SAM placebo