Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.

NCT06163443 | Completed

• 1 other identifier: SW002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled trial will evaluate the impact of methylfolate, pyridoxal-5'-phosphate (P5P), and methylcobalamin supplementation on homocysteine and LDL-C levels in individuals with low to medium cardiac risk and MTHFR, MTR, and MTRR gene polymorphisms. The study aims to explore the efficacy of these vitamins in reducing homocysteine levels, a critical risk factor for cardiovascular disease (CVD), while also monitoring LDL-C levels. The findings will offer valuable insights into personalized CVD prevention and management, emphasizing the significance of genetic factors in nutritional therapy.

Conditions

Hyperhomocysteinemia; Hyperlipoproteinemias

Keywords

Methylfolate; Homocysteine; Genetic Polymorphisms (MTHFR, MTR, MTRR); Cardiovascular Risk; Methylcobalamin; LDL-C; Cholesterol; Low-Density Lipoprotein

Outcome Measures

Primary Outcomes (1)

• Homocysteine levels

  The primary endpoint is the percent change in homocysteine levels from baseline to 6 months of observation, comparing a combined treatment regimen of methylfolate, P5P, and methylcobalamin in MTHFR, MTR, and MTRR polymorphysm.

  180 days

Secondary Outcomes (5)

• Change in LDL-C Levels

  180 days

• Change in HDL-C Levels

  180 days

• Change in Total Cholesterol

  180 days

• Change in Serum Triglycerides

  180 days

• Change in hsCRP Levels

  180 days

Study Arms (2)

Vitamin B group

EXPERIMENTAL

Patients with polymorphisms in the MTHFR, MTR, and MTRR will take methylfolate, P5P, and methylcobalamin genes 2 capsules/day.

Dietary Supplement: Vitamin B

Placebo group

PLACEBO COMPARATOR

Patients with polymorphisms in the MTHFR, MTR, and MTRR will take placebo capsules will be identical in appearance, matched for color coating, shape, and size - 2 capsules/day..

Dietary Supplement: Placebo

Interventions

Vitamin B DIETARY_SUPPLEMENT

MTHFR, MTR, and MTRR polymorphysm based L-methylfolate (1 mg), P5P (pyridoxal-5-phosphate, 50 mg), and Methylcobalamin (500 mcg) prescription

Vitamin B group

Placebo DIETARY_SUPPLEMENT

MTHFR, MTR, and MTRR polymorphysm based placebo prescription

Placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 75.
• Homocysteine levels greater than 15 µmol/L and LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
• Presence of at least one minor allele in any of the following genetic polymorphisms: rs1801133 (MTHFR C677T), rs1801131 (MTHFR A1298C), rs1805087 (MTR A2756G), and rs1801394 (MTRR A66G).

You may not qualify if:

• Personal history of cardiovascular disease or high risk (≥ 20%).
• Triglycerides (TG) ≥ 400 mg/dL.
• Obesity (Body Mass Index \> 32 kg/m\^2).
• Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
• Use of medications or supplements known to affect homocysteine levels, such as B-vitamins and certain antihypertensives, within the last three months.
• Diabetes mellitus.
• Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Triangel Scientific: collaborator
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location

Related Publications (1)

• Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, Pak I, Shrainer E, Ermolaeva M, Kudlay D, Johnson M, Miller R. Effect of Methylfolate, Pyridoxal-5'-Phosphate, and Methylcobalamin (SolowaysTM) Supplementation on Homocysteine and Low-Density Lipoprotein Cholesterol Levels in Patients with Methylenetetrahydrofolate Reductase, Methionine Synthase, and Methionine Synthase Reductase Polymorphisms: A Randomized Controlled Trial. Nutrients. 2024 May 21;16(11):1550. doi: 10.3390/nu16111550.

  PMID: 38892484 RESULT

Related Links

• 10.3390/nu16111550

MeSH Terms

Conditions

Hyperhomocysteinemia; Hyperlipoproteinemias

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: March 2, 2022
• Primary Completion: February 13, 2023
• Study Completion: May 1, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

RU (1)