Acute Cardio-metabolic Responses to Different Forms of Montmorency Tart Cherry Supplementation in Humans With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Fasting Insulin
研究概览
简要总结
The present study examined the effect of Montmorency tart cherry juice and capsules on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants received a single bolus of Montmorency tart cherry juice, Montmorency tart cherry capsules and placebo in a random, crossover trial. Outcome variables were measured immediately pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice and capsules would improve cardio-metabolic markers. Furthermore, it was hypothesised that Montmorency tart cherry capsules would be more beneficial than Montmorency tart cherry juice due to increased bioavailability of phytochemicals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoker,
- •Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education Program-Adult Treatment Panel III guidelines:
- •Waist Circumference: >102cm (men), >88cm (women)
- •Fasting Serum Triglycerides: ≥1.69 mmol.L-1
- •Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
- •Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
- •Fasting Plasma Glucose: ≥6.1 mmol.L-1
排除标准
- •Current or previous history of gastrointestinal, cardiovascular, hepatic or renal disease, currently diagnosed with diabetes or uncontrolled hypertension (≥160/100 mmHg), allergy to maltodextrin or specific fruit products and those currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs) or currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (>14 units per week).
结局指标
主要结局
Change in Fasting Insulin
时间窗: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Systolic and Diastolic Blood Pressure
时间窗: Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
时间窗: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
Change in Fasting Glucose
时间窗: Pre-Bolus and Post-Bolus (1hr, 3hr, 5hr)
次要结局
- Change in Heart Rate(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Augmentation Index(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Cardiac Output(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Stroke Volume(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Aortic Systolic and Diastolic Pressure(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Mean Arterial Pressure(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Resting Energy Expenditure(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Augmentation Pressure(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Total Peripheral Resistance(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
- Change in Respiratory Quotient(Pre-Bolus and Post-Bolus (30min, 1hr, 2hr, 3hr, 4hr, 5hr))
研究者
Terun Desai
PhD Student
University of Hertfordshire