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| Name | Class |
|---|---|
| Triangel Scientific | INDUSTRY |
| Center of New Medical Technologies | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B group | Experimental | Patients with polymorphisms in the MTHFR, MTR, and MTRR will take methylfolate, P5P, and methylcobalamin genes 2 capsules/day. |
|
| 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C Levels | Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) levels. | 180 days |
| Change in HDL-C Levels | Percent change in High-Density Lipoprotein Cholesterol (HDL-C) levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibirsk Oblast | 630090 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38892484 | Result | 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. |
| Label | URL |
|---|---|
| 10.3390/nu16111550 | View source |
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| Placebo | Dietary Supplement | MTHFR, MTR, and MTRR polymorphysm based placebo prescription |
|
| 180 days |
| Change in Total Cholesterol | Percent change in total cholesterol levels in the study participants. | 180 days |
| Change in Serum Triglycerides | Percent change in serum triglycerides. | 180 days |
| Change in hsCRP Levels | Percent change in high-sensitivity C-Reactive Protein (hsCRP) levels. | 180 days |
| ID | Term |
|---|---|
| D020138 | Hyperhomocysteinemia |
| D006951 | Hyperlipoproteinemias |
| ID | Term |
|---|---|
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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