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.

Abstract

Exploring the link between genetic polymorphisms in folate metabolism genes (MTHFR, MTR, and MTRR) and cardiovascular disease (CVD), this study evaluates the effect of B vitamin supplements (methylfolate, pyridoxal-5'-phosphate, and methylcobalamin) on homocysteine and lipid levels, potentially guiding personalized CVD risk management. In a randomized, double-blind, placebo-controlled trial, 54 patients aged 40-75 with elevated homocysteine and moderate LDL-C levels were divided based on MTHFR, MTR, and MTRR genetic polymorphisms. Over six months, they received either a combination of methylfolate, P5P, and methylcobalamin, or a placebo. At the 6 months follow-up, the treatment group demonstrated a significant reduction in homocysteine levels by 30.0% (95% CI: -39.7% to -20.3%) and LDL-C by 7.5% (95% CI: -10.3% to -4.7%), compared to the placebo (p < 0.01 for all). In the subgroup analysis, Homozygous Minor Allele Carriers showed a more significant reduction in homocysteine levels (48.3%, 95% CI: -62.3% to -34.3%, p < 0.01) compared to mixed allele carriers (18.6%, 95% CI: -25.6% to -11.6%, p < 0.01), with a notable intergroup difference (29.7%, 95% CI: -50.7% to -8.7%, p < 0.01). LDL-C levels decreased by 11.8% in homozygous carriers (95% CI: -15.8% to -7.8%, p < 0.01) and 4.8% in mixed allele carriers (95% CI: -6.8% to -2.8%, p < 0.01), with a significant between-group difference (7.0%, 95% CI: -13.0% to -1.0%, p < 0.01). Methylfolate, P5P, and methylcobalamin supplementation tailored to genetic profiles effectively reduced homocysteine and LDL-C levels in patients with specific MTHFR, MTR, and MTRR polymorphisms, particularly with homozygous minor allele polymorphisms.

Keywords: LDL-C; MTHFR; MTR; MTRR polymorphisms; cardiovascular health; homocysteine; methylcobalamin; methylfolate; personalized medicine; pyridoxal-5′-phosphate; triglycerides.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 5-Methyltetrahydrofolate-Homocysteine S-Methyltransferase* / genetics
  • Adult
  • Aged
  • Cholesterol, LDL* / blood
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Ferredoxin-NADP Reductase* / genetics
  • Homocysteine* / blood
  • Humans
  • Male
  • Methylenetetrahydrofolate Reductase (NADPH2)* / genetics
  • Middle Aged
  • Polymorphism, Genetic
  • Pyridoxal Phosphate*
  • Tetrahydrofolates* / administration & dosage
  • Vitamin B 12* / administration & dosage
  • Vitamin B 12* / analogs & derivatives
  • Vitamin B Complex / administration & dosage
  • Vitamin B Complex / pharmacology
  • Vitamin B Complex / therapeutic use

Substances

  • Homocysteine
  • Methylenetetrahydrofolate Reductase (NADPH2)
  • 5-Methyltetrahydrofolate-Homocysteine S-Methyltransferase
  • Cholesterol, LDL
  • methionine synthase reductase
  • Vitamin B 12
  • Pyridoxal Phosphate
  • Ferredoxin-NADP Reductase
  • Tetrahydrofolates
  • mecobalamin
  • MTR protein, human
  • MTHFR protein, human
  • 5-methyltetrahydrofolate
  • Vitamin B Complex

Grants and funding

The authors declare that, in this study, S.Lab (SOLOWAYS), a pharmaceutical company, contributed solely by manufacturing the supplements used in the research. S.Lab (SOLOWAYS) did not participate in the study design; collection, analysis, or interpretation of data; the writing of this article; or the decision to submit it for publication.