Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- C Reactive Protein - Marker of Systemic Inflammation
研究概览
简要总结
The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body's defence [immune] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.
详细描述
Participants will be asked to take one sachet of the immuno-nutrition supplement each day for 6 weeks. The renal dietitian on the research team will provide participants with detailed oral advice on how and when to take the immuno-nutrition supplement.
Participants will need to complete 3-day food diaries at the beginning, mid-way point and end of the study.
The research team will measure weight, height, handgrip strength (a measure of muscle strength), body's composition of fat and muscle using a specialist scale, and skin autofluorescence levels (a measure of toxins called advanced glycation end-products).
The research team will collect the results of routine blood tests. The research team will also collect and store blood samples taken before and after a haemodialysis session to measure some molecules that indicate inflammation.
All of these measurements and samples will be taken at the start of the study, and after 6 weeks of taking the immuno-nutrition supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •CRP level >5.0 mg/L.
- •At least three haemodialysis sessions per week for ≥3 hours using a biocompatible dialyser.
- •Able to give informed consent.
排除标准
- •Treatment with drugs that cause immunosuppression.
- •Non-English speakers or those with special communication needs.
- •Pregnancy, breast feeding or intending pregnancy.
- •Expected survival <6 months.
- •Hospitalisation at the time of screening.
- •Known intolerance or allergy to ONS (or isolated ingredients).
- •Pre-dialysis serum potassium >5.0 mmol/L.
- •Unable to provide informed consent.
研究组 & 干预措施
Immuno-nutrition
Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks.
Participants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.
干预措施: Immuno-nutrition supplement (Dietary Supplement)
结局指标
主要结局
C Reactive Protein - Marker of Systemic Inflammation
时间窗: 6 weeks
C reactive protein levels in mg/L using a high-sensitive laboratory test
Interleukin-6 - Marker of Systemic Inflammation
时间窗: 6 weeks
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Interleukin-8 - Marker of Systemic Inflammation
时间窗: 6 weeks
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
次要结局
- Skeletal Muscle Mass(6 weeks)
- Energy Intake(6 weeks)
- Protein Intake(6 weeks)
- Handgrip Strength - a Measure of Muscle Strength(6 weeks)