Clinical trial NCT06163443: Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
Official title: Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhomocysteinemia
Hyperlipoproteinemias
Keywords: Methylfolate
Homocysteine
Genetic Polymorphisms (MTHFR, MTR, MTRR)
Cardiovascular Risk
Methylcobalamin
LDL-C
Cholesterol
Low-Density Lipoprotein
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Triangel Scientific
name: Center of New Medical Technologies
First posted: 2023-12-08
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Design: Participants with specific genetic polymorphisms and homocysteine levels above 15 µmol/L, without a history of severe CVD or other exclusion criteria, will be enrolled and randomized into two groups: one receiving methylfolate, P5P, and methylcobalamin, and the other a placebo. The study, adhering to ethical standards and informed consent, will involve 54 patients divided equally between the treatment and placebo groups. The primary endpoint will be the percent change in homocysteine levels over six months, with secondary endpoints including changes in LDL-C and other lipid profile components.

Intervention: Participants will receive either the active treatment (L-methylfolate, P5P, and Methylcobalamin) or a placebo, with both groups taking two capsules daily for 180 days. Fasting measurements of lipid profiles and homocysteine levels will be conducted at the start, midpoint, and end of the study.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Homocysteine levels
timeFrame: 180 days
Secondary outcomes:
measure: Change in LDL-C Levels
timeFrame: 180 days
measure: Change in HDL-C Levels
timeFrame: 180 days
measure: Change in Total Cholesterol
timeFrame: 180 days
measure: Change in Serum Triglycerides
timeFrame: 180 days
measure: Change in hsCRP Levels
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibirsk Region
Study officials:
References:
citation: 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.