Cardiovascular disease, endothelial function Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
1. Inorganic nitrate + Vitamin C (12 mg sodium nitrate per kg body weight in in saline solution + 20 mg ascorbic acid per kg body weight in saline solution)
2. Inorganic nitrate + plac
in saline solution)
4. Vitamin C placebo + Inorganic nitrate placebo (given as two separate saline solutions)
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/12/2014: Non-smoking healthy adults aged 18-40 years and aged 55-70 years, with a BMI between 20.0 - 29.9 kg/m2. Previous inclusion criteria: Non-smoking healthy adults aged 18-40 years, with a BMI between 20.0 - 29.9 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Current participation in other research clinical studies 2. Vegetarianism (likely to have very high nitrate intake) 3. High physical activity level (may have BMI in obese range but low fat mass) 4. Weight change more than 3.0 kg in the last 2 months (important influence on systemic metabolism and vascular function). 5. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes). 6. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example flu, Chrohn?s Disease, rheumatoid arthritis. 7. Previous diagnosis of type 1 or type 2 diabetes treated with insulin and oral hypoglycaemic agents (modification of regulation of intermediate metabolism). Type 2 diabetic patients treated with diet only will be included in the study. 8. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism). 9. Drugs: corticosteroids, sildenafil, aspirin, diuretics, beta-blockers, antacids, anticoagulants, nitrate-derived agents, anti-cholinergic, (all drugs may have either an effect on NO production or insulin sensitivity via different mechanisms). Subjects on hormonal therapies (oestrogens, thyroxine, progesteron), anti-hypertensive (Ca++ channel blockers, ACE inhibitors), statins and any other antidyslipidaemic agent, and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if dose has been started/changed in the previous three months. (make sure that these disorders are under strict control to avoid interference with the study outcomes). 10. Haematological disorders including severe anaemia (Hb21 units/week for men and >14 units/week women 13. Blood donations in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic and diastolic BP: Screening, -5', -4', -3', -2', -1', 30', 60', 90', 120', 150', 180', 210', 240' (minutes from intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Forearm blood flow (laser Doppler): -15, 120, 240 minutes from intervention The biomarkers of oxidative stress (nitro-tyrosine) and NO production (nitrate, nitrite, cGMP): Screening, -1', 30', 60', 120', 180', 240' minutes from intervention. | — |
Countries
United Kingdom
Outcome results
None listed