The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Cardiometabolic Risk Factors, Exercise Capacity and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
A randomized, double blind, counterbalanced, placebo controlled independent groups design to determine the effects of 3 month supplementation with tart cherry concentrate on indices of cardiometabolic health, exercise capacity and cognitive function. Following screening and recruitment, participants are familiarised with the testing equipment and procedures after which they will be randomly assigned to receive either Montmorency tart cherry concentrate (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two experimental visits and outcome variables are assessed at baseline (before supplementation) and at 3 months (follow up; after supplementation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The treatment drink (tart cherry concentrate) and placebo are matched for colour and packed in identical plastic containers. The assigned beverages are packed and given to the participants by an independent researcher not involved in the study.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals between the ages of 40-60 years
- •consume on average ≤5 servings of fruits and vegetables per day
- •additionally have ≥1 risk factor for type 2 diabetes
排除标准
- •not regularly taking medication (or stabilised ≥ 3 months, with no adverse symptoms) or antioxidant supplements
- •history of cardiometabolic, gastointestinal disease or malabsorption syndromes
- •stage 2 hypertension (SBP >159 mm Hg or DBP >99 mm Hg)
- •individuals who report changes in dietary or physical activity patterns within 3 months
- •vegetarians, vegans or known eating disorders
- •alcohol intake of more than 21 units per week
- •BMI ≥40 kg/m2
- •are pregnant or planning to become pregnant during the study, lactating, or initiating or changing a hormone replacement therapy regimen within 3 months of the start of the study
研究组 & 干预措施
Montmorency tart cherry concentrate
Participants will consume 30 ml of Montmorency tart cherry concentrate (MC) concentrate (King Orchard farms, USA) twice daily, once in the morning and again in the evening. According to the manufacturer each 30 ml dose of MC is estimated to be equivalent to approximately 90 whole cherries (equating to ~180 cherries per day).
干预措施: Montmorency tart cherry concentrate (Dietary Supplement)
Isocaloric cherry flavoured placebo
The PLA is prepared by mixing by mixing unsweetened black cherry flavoured Kool-Aid (Kraft Foods, United States), dextrose, fructose with water to best match the calorie content of the MC concentrate. Additional lemon juice, for tartness, and artificial food colouring is added so the final product had a similar visual properties to the active comparator.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Endothelial function
时间窗: Change from baseline at 3 months
Flow mediated dilation (% change)
Arterial Stiffness
时间窗: Change from baseline at 3 months
Pulse wave velocity (m/s)
Blood pressure
时间窗: Change from baseline at 3 months
Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg)
次要结局
- Cognitive function(Change from baseline at 3 months)
- Cerebral Blood flow(Change from baseline at 3 months)
- Indices of metabolic health(Change from baseline at 3 months)
- Exercise Capacity(Change from baseline at 3 months)