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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre.
Department of Renal Medicine, Royal Derby Hospital
Derby, Derbyshire, United Kingdom
C Reactive Protein - Marker of Systemic Inflammation
C reactive protein levels in mg/L using a high-sensitive laboratory test
Time frame: 6 weeks
Interleukin-6 - Marker of Systemic Inflammation
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Time frame: 6 weeks
Interleukin-8 - Marker of Systemic Inflammation
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
Time frame: 6 weeks
Skeletal Muscle Mass
Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
Time frame: 6 weeks
Energy Intake
Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
Time frame: 6 weeks
Protein Intake
Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
Time frame: 6 weeks
Handgrip Strength - a Measure of Muscle Strength
Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer
Time frame: 6 weeks
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