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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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High blood pressure is the leading risk factor for heart disease and stroke. Approximately 12% of the population have a particular genetic factor (known as the TT genotype) which increases the risk of high blood pressure. Previous studies conducted at this centre have shown that taking the B-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the TT genotype. It is currently not known how riboflavin lowers blood pressure in those with the TT genotype but it could be as a result of altering blood levels of nitric oxide. Nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. However, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. Furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. Therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. It is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dose 1 | Active Comparator |
| |
| Dose 2 | Active Comparator |
| |
| Dose 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Riboflavin 1.6mg/d |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Branchial blood pressure | Change over 16 weeks |
| Diastolic blood pressure | Branchial blood pressure | Change over 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Measured by Flow Mediated Dilation | Change over 16 weeks |
| Nitric oxide bioavailability | Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser |
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Inclusion Criteria:
Exclusion Criteria:
Male only
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University | Coleraine | Co.Londonderry | BT52 1SA | United Kingdom |
Company funded work, no plan to share IPD
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Double blind placebo controlled parallel design
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| Dietary Supplement |
Riboflavin 1.6mg/d |
|
| Riboflavin 5mg/d | Dietary Supplement | Riboflavin 5mg/d |
|
| Riboflavin 20mg/d | Dietary Supplement | Riboflavin 20mg/d |
|
| Change over 16 weeks |
| Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker) | Measured on automatic analyser | Change over 16 weeks |
| Pyridoxal phosphate (Vitamin B6 marker) | Measured on HPLC | Change over 16 weeks |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |