Investigating the Acute and Chronic Effects of Dietary Proteins on Markers of Vascular Function, Ambulatory Blood Pressure, Insulin Resistance and Lipid Metabolism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in 24-h ambulatory blood pressure
研究概览
简要总结
Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. This research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals.
This research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. This has generated different sample size requirements for the two studies (Actual participants on the acute study: n=27, and on the chronic study: n=38).
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
- 30 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed consent form
- •Blood pressure: 120/80-159/99
- •Age: 30-77 years
- •BMI 20-40 kg/m2
- •Glucose <7 mmol/l (Not diagnosed with diabetes)
- •Chol <8 mmol/l
- •TAG <4 mmol/l
- •Normal liver and kidney function
- •Haemoglobin (>110 g/dl women; 140g/dl men)
排除标准
- •Milk allergy, lactose allergy
- •Coeliac disease
- •Renal, gastrointestinal, respiratory, endocrine, liver disease or cancer
- •Surgery in the previous 6 months
- •Secondary hypertension
- •Excess alcohol consumption (drinking >28 unit/wk man; >21 unit/wk women)
- •Taking nutritional supplementation (e.g. fish oil, proteins)
结局指标
主要结局
Change in 24-h ambulatory blood pressure
时间窗: Chronic study: Baseline and week 8 assessments for the three dietary intervention arms, Acute study: automated ambulatory blood monitor measures every 15 minutes for 3 hours after both meals, then every 30 minutes for day
次要结局
- Changes in vascular reactivity measured by flow-mediated dilation (FMD)(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min)
- Changes in plasma lipids(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial)
- Changes in inflammatory markers(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial)
- Changes in arterial stiffness measured by pulse wave analysis (PWA)(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min)
- Changes in arterial stiffness measured by digital volume pulse (DVP)(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min)
- Changes in markers of insulin resistance(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial)
研究者
Julie Lovegrove
Professor
University of Reading