ISRCTN85926713已完成不适用
Investigation of the effects of beetroot juice supplementation on blood pressure in older overweight and obese subjects: a randomised controlled trial
ewcastle University (UK)0 个研究点目标入组 24 人开始时间: 2014年5月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Non-smoking men and women
- •2. Healthy (no established diagnosis)
- •3. 55-70 years old
- •4. Body Mass Index (BMI) of 25-40 kg/m2
排除标准
- •1. Current participation in other clinical investigations
- •2. Physical disabilities, trauma or surgery that limit mobility and impede physical performance (i.e. not able to comply with the assessment of physical strength and influence on cardio-metabolic functions)
- •3. Vegetarianism (likely to have very high nitrate intake)
- •4. Aversion to beetroot consumption or inability to comply with the study diet (lack of compliance)
- •5. Weight change more than 3.0 kg in the last 3 months (important influence on systemic metabolism and vascular function)
- •6. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes)
- •7. Chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example, severe hypertension (SBP/DBP=>180 mmHg/>110), kidney stones, gallstones or rheumatoid arthritis
- •8. Previous diagnosis of type 1 or type 2 diabetes treated with insulin (modification of regulation of intermediate metabolism)
- •9. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
- •10. Drugs: oral corticosteroids, sildenafil, diuretics, laxatives, anticoagulants, nitrate-derived agents, anti-cholinergic (all drugs have either an effect on NO production or insulin sensitivity via different mechanisms)
- •11. Subjects on hormonal therapies (oestrogens, thyroxine, progesterone, oral hypoglycaemic agents), anti-hypertensive (beta-blockers, calcium antagonists, ACE inhibitors and angiotensin receptor inhibitors), statins and any other anti-dyslipidaemic agent and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if dose has been started/changed in the previous 3 months (make sure that these disorders are under strict control to avoid interference with the study outcomes)
- •12. Haematological disorders including severe anaemia (Hb < 10 mg/dL) (risk for the participant and effects on the study outcomes)
- •13. Major surgical operations interfering with the study outcomes (systemic effects on study outcomes)
- •14. Alcohol intake >21 units/week for men and >14 units/week for women
- •15. Non-English speakers or volunteers requiring translators or interpreters (since these services are not available for this study)
研究者
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