Effects of Krill Oil Supplementation on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Grip strength
研究概览
简要总结
The age-related loss of muscle mass and function, sarcopenia, has several deleterious effects, such as a reduction in the quality of life and an increase in the incidence of falls, often leading to hospitalisation. The prevalence of sarcopenia is unclear but is estimated to be between 4.6 and 7.9% and the loss of skeletal muscle mass and function is accelerated in people with type 2 diabetes. With the percentage of older people and the percentage of people with type 2 diabetes predicted to rise in coming years it is crucial to develop therapies to increase muscle mass and function. Alterations in nutrition have also been suggested to be of therapeutic use in sarcopenia. Epidemiological data showed that the consumption of fatty fish is positively associated with muscle function in older population, indicating a potential role for long-chain n-3 polyunsaturated fatty acids (LCn-3 PUFA) in increasing muscle mass and function in older people. The aim of the current study, therefore, is to determine the effects of krill oil supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician confirmed type 2 diabetes.
- •Age >/= 40 years
- •No changes in anti-diabetic medication in the last 3 months.
- •Muscle weakness (grip strength <27kg and females <16kg)
排除标准
- •BMI of 45 or higher
- •BP of 160/100mmHg or higher
- •Cancer or cancer that has been in remission <5 years
- •Any medical condition that prevents participants from exercising safely
- •On anticoagulant therapy
- •Allergies to seafood
- •Regular consumption of more than 2 portions of oily fish per week
- •Currently consuming omega-3 supplements
结局指标
主要结局
Grip strength
时间窗: Change from baseline to one year
Change in Grip strength
次要结局
- body mass(Change from baseline to one year)
- Lean mass(Change from baseline to one year)
- SPPB(Change from baseline to one year)
- HbA1c(Change from baseline to one year)
- Blood pressure(Change from baseline to one year)
- Body fat(Change from baseline to one year)
- BMD(Change from baseline to one year)
- Erythrocyte fatty acid profile(Change from baseline to one year)
- BMC(Change from baseline to one year)