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| Name | Class |
|---|---|
| University College Dublin | OTHER |
| Connolly Hospital Blanchardstown | OTHER |
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Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice.
This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate rich beetroot juice | Experimental | Concentrated, beetroot juice is a rich source of dietary nitrate. |
|
| Nitrate depleted placebo beetroot juice | Placebo Comparator | Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary nitrate | Dietary Supplement | 140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in ambulatory nocturnal blood pressure | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 24h blood pressure | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in plasma nitrate and nitrite | Comparison of the change after nitrate-rich beetroot juice compared to placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liam Cormican, MD | Connolly Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connolly Hospital, Blanchardstown | Dublin | D15 | Ireland |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Dietary Supplement | 140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects. |
|
|
| Day 1, day 15, day 29 |
| Difference in fasting glucose | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in OSAS symptomatology | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in 2h post OGT glucose | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in overnight oximetry | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in exhaled nitric oxide | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| Difference in vigilance scores derived from the Conner's Continuous Performance Test. | Comparison of the change after nitrate-rich beetroot juice compared to placebo. | Day 1, day 15, day 29 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |