Clinical trial NCT06264570: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperhomocysteinemia
Keywords: Hyperhomocysteinemia
Cardiovascular diseases
Bioactive substances
Genetically-determined approach
Nutrigenomics
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
First posted: 2024-02-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.
timeFrame: 6 months
Secondary outcomes:
measure: change in the level of very low density lipoproteins
timeFrame: 6 months
measure: change of anxiety when using dietary supplements accessed by the Spielberg scale
timeFrame: 6 months
measure: change of depression when using dietary supplements by the Becks scale
timeFrame: 6 months
measure: occurrence of major cardiovascular events during follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: