ISRCTN67978523已完成未知
Effects of dietary nitrate and folate supplementation on blood pressure in hypertensive Tanzanians: a feasibility trial
Institute of Cellular Medicine, Newcastle University0 个研究点目标入组 47 人开始时间: 2018年11月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 47
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32729923/ results (added 03/08/2020) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31872153/ Design and baseline characteristics (added 17/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 50-70 years old
- •2. Non-smokers
- •3. Drug naïve
- •4. Hypertension (stage 1, systolic blood pressure 130-170 mmHg)
- •5. BMI 18-40 kg/m²
排除标准
- •1. Current participation in other clinical investigations
- •2. Physical disabilities, trauma or surgery which limit mobility and affect participation to the trial
- •3. Vegetarianism
- •4. Aversion to beetroot consumption or inability to comply with the study diet
- •5. Substantial weight change in the last 3 months
- •6. Active cancer and any diagnosis of malignant cancer in the last 5 years
- •7. Chronic and acute metabolic and inflammatory conditions interfering with the study outcome (e.g. history of severe liver disease, inflammatory bowel diseases or rheumatoid arthritis)
- •8. Previous diagnosis of type 1 or type 2 diabetes treated with insulin
- •9. Taking any drugs that have an effect on nitric oxide production or insulin sensitivity, including oral corticosteroids, sildenafil, anti-hypertensive (beta-blockers, calcium antagonists, ace-inhibitors and angiotensin receptors inhibitors), diuretics, laxatives, anticoagulants, nitrate derived agents and anti-cholinergics
- •10. Taking hormonal therapies (oestrogens, thyroxine, progesterone, oral hypoglycaemic agents) if the dose has been started/changed in the previous 3 months
- •11. Taking statins and any other anti-dyslipidaemic agent if the dose has been started/changed in the previous 3 months
- •12. Taking psychiatric drugs (antidepressants, sedatives, antipsychotics) if the dose has been started/changed in the previous 3 months
- •13. History of severe anaemia (Hb < 8mg/dL) (risk for the participant and effects on the study outcomes).
- •14. Current diagnosis of severe infectious diseases (known HIV positive, malaria, hepatitis, yellow fever etc)
- •15. Major surgical operations interfering with the study outcomes
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