NCT03594097终止不适用
Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Lean mass
研究概览
简要总结
The purpose of this study is to identify whether the combination of coconut Nourish and Queen Garnet plum are able to attenuate ageing-related complications, including muscle mass loss and inflammation. The study endpoints will measure muscle mass as the primary endpoint with blood lipids, glucose, blood pressure, and inflammatory markers serving as some of the secondary endpoints. As the two products are rich in dietary fibre and anthocyanins, respectively, the study outcome will help to understand role of these dietary components in improving complications that are seen quite frequently in elderly population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years and above
- •Able to give written informed consent
- •Able to read, write and speak English
- •Body mass index less than or equal to 30 kg/m^2
- •Either do not suffer from a chronic disease or, if suffering from a chronic disease, then key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) are within the normal physiological range
- •Either take no chronic medication or have been treated with a stable dosage of medication for at least 3 months as confirmed by family physician.
- •Either take no supplements, or have been utilizing supplements in a stable and consistent dose for at least 3 months, and plan to continue taking a stable and consistent dose throughout the entire study.
排除标准
- •Consumption of more than 2 alcoholic drinks/day, or > 14 alcoholic beverages a week, or history of alcoholism or drug dependence
- •Uncontrolled hypertension, recent stroke or myocardial infarction, hypothyroidism, diabetes mellitus or kidney disease
- •Major disability or disorder requiring continuous medical attention and treatment such as chronic heart failure, liver disease, renal failure or cancer, chronic infections or major surgery within 6 months prior to randomization
- •Despite taking medication, do not have values for key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) within normal physiological ranges
- •Fasting glucose ≥ 5.6 mmol/L
- •Triglycerides ≥ 1.7 mmol/L
- •Systolic and diastolic blood pressures ≥130/85 mmHg
- •High-density lipoprotein cholesterol ≤1.0 mmol/L
- •Have gained or lost >10 lbs in the previous 3 months, or plan to lose weight at any time during the study
- •History of allergy to coconut, plum, plain flour, butter or milk
- •Any planned surgeries during the study
结局指标
主要结局
Lean mass
时间窗: 8 weeks
Measured using dual-energy x-ray absorptiometry (DXA)
次要结局
- Triceps skinfold(8 weeks)
- Calf circumference(8 weeks)
- Arm circumference(8 weeks)
- Bone mineral density(8 weeks)
- Bone mineral content(8 weeks)
- Blood glucose(8 weeks)
- Blood C-reactive protein(8 weeks)
- Body weight(8 weeks)
- Waist circumference(8 weeks)
- Handgrip dynamometer(8 weeks)
- Blood triglycerides(8 weeks)
- Body mass index(8 weeks)
- Blood total cholesterol(8 weeks)
- Blood interleukin 1 beta(8 weeks)
- Wrist circumference(8 weeks)
- Five times chair standing test(8 weeks)
- Blood pressure(8 weeks)
- Heart rate(8 weeks)
- Fat mass(8 weeks)
- Blood high-density lipoprotein cholesterol(8 weeks)
- Blood tumor necrosis factor alpha(8 weeks)
- Blood low-density lipoprotein cholesterol(8 weeks)
研究者
研究点 (4)
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