Nutrition and Sarcopenia in Frail Elderly: a Randomized Controlled Trial of the Effects of Marine Protein Hydrolysates to Improve Physical Performance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
The purpose of this study is to determine whether a marine protein hydrolysate given as a supplement can prevent age related loss of muscle mass and loss of physical function in frail elderly. The study will recruit elderly living at home with help from municipal health care services, and a secondary goal of the study is to describe food habits, seafood intake and nutritional status in this group of patients.
Edit: the recruitment procedure was changed in august 2017, to include elderly without help from municipal health care services. Participants are now recruited trough media and organizations for elderly, and these changes in recruitment procedure was approved by the ethics committee august 2017.
详细描述
The overall objective in this project is to study how nutrition influences frailty and physical function in home-dwelling elderly.
The study will seek to answer the following hypotheses (RCT):
- Sarcopenia as measures by SPPB, grip strength, antropometry and gait speed is significantly associated with nutritional status and intake of protein in frail elderly.
- A supplement of 3000mg of marine peptides pr. day in 12 months in the intervention group will improve the score on SPPB and other sarcopenia-related outcomes like grip strength, antropometric measures or gait speed compared to the placebo group.
To supplement the results of the RCT, interviews will be performed with selected participants to answer the following question:
- How do frail elderly describe their own nutritional status and need of help from municipal health care service related to nutrition? The data collection will be made in the participants' home at baseline and after 6 and 12 months. The patients will complete the Short Physical Performance Test (SPPB), Grip Strength measurement and anthropometric measurements (weight, height, calf circumference and mid-arm circumference). Assessment of nutritional status will be made by Mini Nutritional Assessment (MNA). Seafood intake and protein intake will be assessed by a food frequency questionnaire based on previously used and validated questionnaires. Daily energy intake will be estimated by a 24-hour multiple pass recall of food intake. Health related quality of life will be assessed by the EQ-5D-5L questionnaire (EuroQol). In addition, the participants will be asked to take blood tests to be analyzed for vitamin D, nutritional and inflammation markers.
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
- 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
- 否
入选标准
- •able and willing to give consent
- •Must be able to swallow tablets
排除标准
- •diabetes (recieve treatment)
- •active cancer illness
- •progressive muscle illness (e.g. multiple sclerosis ALS)
- •kidney failure
- •short life expectancy (<1år)
- •allergies of fish protein.
研究组 & 干预措施
Intervention
Marine protein hydrolysate pills (3000mg)
干预措施: Marine Protein hydrolysate (Dietary Supplement)
Control
Placebo pills (gum arabicum)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: 6 and 12 months
physical test assessing balance, lower limb function and gait speed.
次要结局
- Grip strength(6 and 12 months)
- Gait speed(6 and 12 months)
- Health related quality of life(6 and 12 months)
- Antropometric measures(6 and 12 months)