The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Body weight
研究概览
简要总结
Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished
The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.
详细描述
Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome.
Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community.
The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements.
The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of homecare services in the municipality of Bergen
- •Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment)
- •Informed consent by participant
- •Informed consent by participants and close relatives or guardian in case of dementia
排除标准
- •Terminal care patients with < 3 month life expectancy
- •Patients using parenteral or enteral nutrition
- •Patients prescribed oral nutritional supplementation before recruitment
- •Pregnancy
- •Diabetes Mellitus
- •Lactose intolerance
- •Patients without a norwegian personal identification number
- •Psychiatric patients
结局指标
主要结局
Change in Body weight
时间窗: At day 0, 35 and 70
Participants will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using portable digital scales.
Change in Body composition
时间窗: At day 0, 35 and 70
A Bioelectric impedance analysis will be used to calculate change in body composition. Measurements will be conducted by a device sending weak electric signals through the participant's body. The method is non-invasive and is commonly used by medical, health and fitness professionals.
Change in Hand grip strength
时间窗: Assessment at day 0, 35 and 70.
Hand grip strength will be measured in kg with a handgrip dynamometer. Subjects will be asked to perform a maximal contraction for a few seconds with the non-dominant hand three times with about 10-20 seconds between each trial.
次要结局
- Change in Nutritional intake(At day 0, 35 and 70)
- Change in Quality of life(At day 0, 35 and 70)