NCT03625596已完成不适用
The Effects of Nutritional Supplements on Postprandial Nitric Oxide Bioactivity in Abdominally Obese Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Nitric oxide bioavailability
研究概览
简要总结
Obese people have a disturbed postprandial metabolism and thereby a decreased postprandial vascular function. Nitric oxide plays an important role in the postprandial vascular function. Multiple studies already focused on various nutritional compounds to improve the postprandial vascular function by increasing the nitric oxide bioactivity. However, the vast majority of the trials has been performed with relatively high doses of the individual components, which are problematic to convert into daily food measures, thereby preventing translation of these findings. Well-designed trails studying the effect of feasible amounts of nutritional supplements on the bioactivity of nitric oxide and vascular function are missing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged between 40-70 years
- •Waist circumference ≥ 102
- •Fasting plasma glucose < 7.0 mmol/L
- •Fasting serum total cholesterol < 8.0 mmol/L
- •Stable body weight (weight gain or loss < 3 kg in the past three months)
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- •No difficult venipuncture as evidenced during the screening visit
- •No current smoker
- •No diabetic patients
- •No familial hypercholesterolemia
- •No abuse of drugs
- •No more than 3 alcoholic consumptions per day
- •No use of medication known to treat blood pressure, lipid or glucose metabolism
- •No use of an investigational product within another biomedical intervention trial within the previous 1-month
- •No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- •No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- •Willingness to give up the use of antibacterial mouth wash or antibacterial toothpaste, chewing-gum and tongue- scraping on the morning of each experimental test day
排除标准
- •Fasting plasma glucose ≥ 7.0 mmol/L
- •Fasting serum total cholesterol ≥ 8.0 mmol/L
- •Current smoker, or smoking cessation <12 months
- •Diabetic patients
- •Familial hypercholesterolemia
- •Abuse of drugs
- •More than 3 alcoholic consumptions per day
- •Unstable body weight (weight gain or loss > 3 kg in the past three months)
- •Use medication known to treat blood pressure, lipid or glucose metabolism
- •Use of an investigational product within another biomedical intervention trial within the previous 1-month
- •Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- •Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- •Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- •Not or difficult to venipuncture as evidenced during the screening visit
结局指标
主要结局
Nitric oxide bioavailability
时间窗: Change from baseline at 2 hours after supplement intake
Flow-mediated vasodilation (FMD) of the brachial artery
次要结局
- Nitric oxide bioavailability(During 3 hours following supplement intake)
- Vascular function markers(Change from baseline at 2 hours after supplement intake)
- Cardiometabolic risk markers (1)(Change from baseline at 2 hours after supplement intake)
- Cardiometabolic risk markers (2)(Change from baseline at 2 hours after supplement intake)
- Cardiometabolic risk markers (3)(Change from baseline at 2 hours after supplement intake)
- Postprandial metabolism (1)(During 3 hours following supplement intake)
- Postprandial metabolism (2)(During 3 hours following supplement intake)
研究者
研究点 (2)
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