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临床试验/ISRCTN98942199
ISRCTN98942199已完成未知

Acute effects of dietary nitrate and vitamin C supplementation on blood pressure and endothelial function in young and older human subjects: a 2*2 factorial cross-over trial

The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 10 人开始时间: 2014年2月26日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
10

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

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