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

Launched by S.LAB (SOLOWAYS) · Feb 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a personalized approach to treat patients with high levels of homocysteine in their blood, a condition known as hyperhomocysteinemia. High homocysteine can increase the risk of serious health issues like heart disease and stroke. The researchers want to see if using specific bioactive substances—natural compounds that can affect health—can help bring homocysteine levels down to safe ranges over a six-month period. Participants will have regular check-ins at one, three, and six months to monitor their progress.

To be eligible for the trial, participants should be adults aged 18 to 80 with elevated homocysteine levels (above 15 µmol/L) and high LDL cholesterol (1.4 mmol/L or higher). They should not have taken any medications or supplements that could affect homocysteine levels for at least a month before joining. Participants will be randomly assigned to either receive the treatment or a placebo (an inactive substance) and will be monitored for changes in their homocysteine levels, cholesterol, and overall well-being. This study is currently recruiting volunteers, and their findings could help improve treatment options for people with high homocysteine levels.

Gender

ALL

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.