Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels i… (NCT06163443) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
Russia54 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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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.