Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactive lozenge | Placebo Comparator | Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks |
|
| Methylcobalamin | Experimental | Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactive lozenge | Dietary Supplement | Manufactured to mimic 1mg methylcobalamin lozenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of plasma total homocysteine of vegetarians | 16 weeks per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in systolic and diastolic blood pressure | 16 weeks per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in body mass index | 16 weeks per participant |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amalia A Tsiami, PhD | University of West London | Study Director |
| David C Chappell, PhD | University of West London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of West London | London | Middlesex | TW8 9GA | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| D020138 | Hyperhomocysteinemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
Not provided
Not provided
| ID | Term |
|---|---|
| C019476 | mecobalamin |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methylcobalamin | Dietary Supplement | Aimed at reducing plasma tHcy. |
|
|
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |