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

Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels, Prospective,Double-blind Randomised Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperhomocysteinemia
• Intervention / Treatment: Dietary supplement: B-TMG supplementation; Dietary supplement: B-SAM supplementation; Other: B-TMG placebo; Other: B-SAM placebo

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibisk Region
    • Novosibirsk, Novosibisk Region, Russian Federation, 630090
      • Recruiting
      • Center of New Medical Technologies
      • Contact: Andrei AV Ponomarenko, MD; Phone Number: +79628316017; Email: dayshadoff@gmail.com
      • Contact: Elena EI Krykova; Phone Number: +79133825952; Email: krukova_ei@cnmt.ru
      • Principal Investigator: Eugene EA Pokushalov, PhD
      • Sub-Investigator: Andrei AV Ponomarenko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B-TMG experimental group; Subjects with normal COMT gene and MTHFR gene polymorphism	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
Experimental: B-SAM experimental group; Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene	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
Placebo Comparator: B-TMG placebo group; Subjects with normal COMT gene and MTHFR gene polymorph polymorphism ysm	Other: B-TMG placebo; B-TMG placebo for subjects with normal COMT gene and MTHFR gene polymorphism
Placebo Comparator: B-SAM placebo group; Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene	Other: B-SAM placebo; B-SAM placebo for Subjects with COMT gene polymorphism or normal COMT gene and normal MTHFR gene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
occurrence of major cardiovascular events during follow-up	6 months
change in the level of very low density lipoproteins	6 months
change of anxiety when using dietary supplements accessed by the Spielberg scale	6 months
change of depression when using dietary supplements by the Becks scale	6 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular diseases; Hyperhomocysteinemia; Nutrigenomics; Bioactive substances; Genetically-determined approach
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Metabolism, Inborn Errors; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Vitamin B Deficiency; Hyperhomocysteinemia
• Other Study ID Numbers: SW007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No