Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Keywords
Haemodialysis, Systemic inflammation, Skeletal muscle mass, Immuno-nutrition
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTImmuno-nutrition supplement
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.
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
University of Nottingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C Reactive Protein - Marker of Systemic Inflammation | 6 weeks | C reactive protein levels in mg/L using a high-sensitive laboratory test |
| Interleukin-6 - Marker of Systemic Inflammation | 6 weeks | Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay |
| Interleukin-8 - Marker of Systemic Inflammation | 6 weeks | Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Mass | 6 weeks | Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment. |
| Handgrip Strength - a Measure of Muscle Strength | 6 weeks | Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer |
| Energy Intake | 6 weeks | Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics |
| Protein Intake | 6 weeks | Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Immuno-nutrition supplement: 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Hospitalisation before starting baseline assessments | 1 |
| Overall Study | Received a kidney transplant | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Immuno-nutrition |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 13 |
| C reactive protein | 7.6 mg/L |
| Energy intake | 26.6 kcal/kg of body weight/day |
| Handgrip strength | 23.8 kg |
| Interleukin-6 | 15.3 pg/mL |
| Interleukin-8 | 7.0 pg/mL |
| Protein intake | 1.0 g/kg of body weight/day |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
| Skeletal muscle mass | 26.7 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
C Reactive Protein - Marker of Systemic Inflammation
C reactive protein levels in mg/L using a high-sensitive laboratory test
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | C Reactive Protein - Marker of Systemic Inflammation | 7.3 mg/L |
Primary
Interleukin-6 - Marker of Systemic Inflammation
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Interleukin-6 - Marker of Systemic Inflammation | 10.5 pg/mL |
Primary
Interleukin-8 - Marker of Systemic Inflammation
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Interleukin-8 - Marker of Systemic Inflammation | 4.9 pg/mL |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Energy Intake | 27.2 kcal/kg of body weight/day |
Secondary
Handgrip Strength - a Measure of Muscle Strength
Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer
Time frame: 6 weeks
Population: Handgrip strength was not measured in 2 participants due to arthritis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Handgrip Strength - a Measure of Muscle Strength | 24.4 kg |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Protein Intake | 1.1 g/kg of body weight/day |
Secondary
Skeletal Muscle Mass
Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
Time frame: 6 weeks
Population: Skeletal muscle mass assessment requires participants to stand in the InBody equipment; therefore, skeletal muscle mass was not measured in 2 participants due to leg amputations. A contraindication for using the InBody equipment is having body metal implants; therefore, skeletal muscle mass was not measured in 1 participant due to this reason.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuno-nutrition | Skeletal Muscle Mass | 26.7 kg |