Effects of vitamin C and inorganic nitrate on blood pressure and vascular health

Not Applicable

Completed

• Conditions: Cardiovascular disease, endothelial function; Circulatory System; Cardiovascular disease, unspecified

• Registration Number: ISRCTN98942199
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/30930132/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-26
• Study Completion: 2016-01-31
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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 (Hb< 10mg/dL) (risk for the participant and effects on the study outcomes).
11. Major surgical operations interfering with the study outcomes (systemic effects on study outcomes).
12. Alcohol intake >21 units/week for men and >14 units/week women
13. Blood donations in the previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified