To Examine the Effect of Dietary Supplementation With Fish Oils With Dairy or Plant Based Lipids on Mitochondrial, Physical, and Cognitive Function, in Elderly Humans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Mitochondrial respiration
研究概览
简要总结
The aim of this study is to determine whether dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial, physical, and cognitive function.
详细描述
Physical and cognitive function decline as we get older and this may be due to changes within the mitochondria, organelles that regulate energy production in our cells. The ability of the mitochondria to produce energy can be affected by diet, and the composition of lipids in the cell is an important factor in determining how effective our mitochondria are. Dairy and plant based lipids differ in composition and therefore may differ in their ability to affect mitochondrial function when combined with fish oils (FO). The primary objective of this study is to determine whether supplementation with dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial function. Additional exploratory objectives are 1) skeletal muscle and physical function and 2) cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
After subjects have successfully completed the screening, they will be randomly allocated in a 1:1 ratio, using a 4-code system, to one of the two interventions (intervention or control). The intervention and control will each be individually coded with a randomly generated 3 letter coding system with 2 codes allocated to intervention product and the other 2 codes allocated to the control product. sachets will be generated by the product manufacturer and the corresponding blinding label will be added to the sachets, prior to shipment to the study sites. The un-blinding-key will be sent to the project leaders in sealed envelopes. In this way, both the participants and principle investigator will be blinded throughout the study.
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
- •Male or/and female;
- •Caucasian;
- •Age ≥ 65 years;
- •BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
- •Normal physical activity levels: maximum of 1 hour per week engagement in structured exercise of moderate to high intensity;
- •Subject should be in sufficient health to participate in the experiments, to be judged by the site-specific responsible physician, based on the subject's medical history.
排除标准
- •Habitual smoker within the past 5 years;
- •Excessive alcohol use (greater than 20g per day) and/or drug abuse;
- •Subjects with diagnosed diabetes mellitus type 2;
- •Significant food allergies or intolerances concerning the study products, e.g. cow's milk protein allergy
- •Participation in another biomedical study possibly interfering with the study results within 1 month before the first study visit;
- •Medication use e.g. antithrombotic medications known to hamper subject's safety during the study procedures;
- •Subjects habitually taking fish oil supplements within 3-months of the initial study visit or habitually taking supplements that are likely to affect the main study outcomes;
- •Subjects who do not want to be informed about unexpected medical findings;
- •Subjects who do not want their treating physician to be informed about unexpected medical findings;
- •Inability to participate and/or complete the required measurements
结局指标
主要结局
Mitochondrial respiration
时间窗: 12 weeks
Ex vivo mitochondrial respiration expressed by O2flux in pmol/mg wet weight/second
次要结局
- Physical function(12 weeks)
- Cognitive Function(12 Weeks)