Effects of 7-day Continuous Montmorency Tart Cherry Juice Supplementation in Metabolic Syndrome Participants: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 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 on functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome. Participants consumed Montmorency tart cherry juice or a placebo beverage continuously for 7 days in a randomised, crossover trial. Outcome variables were measured immediately prior to supplementation and post-supplementation. Furthermore, on the 7th day of supplementation outcome variables were measured pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart cherry juice would improve cardio-metabolic markers, particularly fasting insulin and systolic blood pressure. Furthermore, the study aimed to identify the mechanism of action for any effects of Montmorency tart cherry juice on blood pressure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 fructose, maltodextrin or specific fruit products
- •Currently taking medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs)
- •Currently using any nutritional or antioxidant supplement. Heavy alcohol consumption (>14 units per week).
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Montmorency Tart Cherry Juice
干预措施: Montmorency Tart Cherry Juice (Dietary Supplement)
结局指标
主要结局
Change in Fasting Insulin
时间窗: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Systolic and Diastolic Blood Pressure
时间窗: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour)
Change in Fasting Glucose
时间窗: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
Change in Fasting Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL)
时间窗: Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour)
次要结局
- Change in Cardiac Haemodynamics(Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour))
- Change in Angiotensin Converting Enzyme Inhibition activity(Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (1 hour, 3 hour, 5 hour))
- Change in 24-hour Ambulatory Blood Pressure(Baseline, Post-Supplementation (7 days))
- Change in Pulse Wave Analysis(Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour))
- Change in HOMA2-IR, HOMA%S and HOMA%B(Baseline, Post-Supplementation (7 days))
- Change in Resting Metabolic Rate(Baseline, Post-Supplementation (7 days) and Acute Post-Bolus (30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour))
研究者
Terun Desai
PhD Student
University of Hertfordshire