ISRCTN59029976已完成未知
A pilot randomized controlled study to evaluate the effect of inorganic nitrate supplementation during caloric restriction on energy metabolism, vascular health and cognition in overweight and obese subjects
niversity of Naples Federico II0 个研究点目标入组 29 人开始时间: 2022年12月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 29
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36839248/ (added 29/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females aged 50 - 75 years
- •2. Overweight and obese subjects (BMI range: 25-40 kg/m²)
- •3. Non-smokers
- •4. Weight stable
排除标准
- •1. Current participation in other research clinical studies
- •2. Vegetarianism (likely to have very high nitrate intake)
- •3. Weight change more than 3.0 kg in the last 2 months (important influence on systemic metabolism and vascular function)
- •4. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes)
- •5. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example, flu, Crohn’s disease, rheumatoid arthritis
- •6. Previous diagnosis of type 1 or type 2 diabetes treated with insulin (modification of regulation of intermediate metabolism). Type 2 diabetic patients treated with diet only or and oral hypoglycaemic agents with dose stable for at least 3 months will be included in the study
- •7. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
- •8. Drugs: corticosteroids, sildenafil, aspirin, NSAIDs, diuretics, antacids, anticoagulants, nitrate-derived agents, anti-cholinergic, (all drugs may have either an effect on NO production or insulin sensitivity via different mechanisms)
- •9. Subjects on hormonal therapies (oestrogens, thyroxine, progesteron), anti-hypertensive (Ca++ channel blockers, ACE inhibitors, beta-blockers,), statins and any other antidyslipidaemic agent, and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if the 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)
- •10. Severe haematological disorders (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 for women
- •13. Blood donations in the previous 3 months
研究者
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