An interventional study of Immuno-nutrition supplement in Chronic Kidney Disease Requiring Chronic Dialysis, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
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.
University of Nottingham is the lead sponsor of 463 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: 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.
Also known as: Oral Impact®, Nestlé
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
| Milestone | Immuno-nutrition |
|---|---|
| Started | 17 |
| Completed | 14 |
| Not completed | 3 |
| Withdrew: Received a kidney transplant | 1 |
| Withdrew: Hospitalisation before starting baseline assessments | 1 |
| Withdrew: Withdrawal by subject | 1 |
C reactive protein levels in mg/L using a high-sensitive laboratory test
| mg/L | Immuno-nutrition |
|---|---|
| C Reactive Protein - Marker of Systemic Inflammation | 7.3 (2.9 to 22.0) |
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
| pg/mL | Immuno-nutrition |
|---|---|
| Interleukin-6 - Marker of Systemic Inflammation | 10.5 (8.4 to 25.0) |
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
| pg/mL | Immuno-nutrition |
|---|---|
| Interleukin-8 - Marker of Systemic Inflammation | 4.9 (2.2 to 7.8) |
Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
| kg | Immuno-nutrition |
|---|---|
| Skeletal Muscle Mass | 26.7 (23.9 to 32.3) |
Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
| kcal/kg of body weight/day | Immuno-nutrition |
|---|---|
| Energy Intake | 27.2 (22.3 to 31.6) |
Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
| g/kg of body weight/day | Immuno-nutrition |
|---|---|
| Protein Intake | 1.1 (1.0 to 1.4) |
Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer
| kg | Immuno-nutrition |
|---|---|
| Handgrip Strength - a Measure of Muscle Strength | 24.4 (18.9 to 30.8) |
Collected over Reporting/recording of adverse event data was conducted from the baseline assessment until the end of the 6-week intervention period.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immuno-nutrition | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | Immuno-nutrition |
|---|---|
| Intolerance to the immuno-nutrition supplementGastrointestinal disorders | 1/16 |
| Age, Continuous(years) | Immuno-nutrition |
|---|---|
| Mean | 69 ± 13 |
| Sex: Female, Male(Participants) | Immuno-nutrition |
|---|---|
| Female | 2 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Immuno-nutrition |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| C reactive protein(mg/L) | Immuno-nutrition |
|---|---|
| Median | 7.6 (4.8 to 32.3) |
| Interleukin-6(pg/mL) | Immuno-nutrition |
|---|---|
| Median | 15.3 (7.0 to 22.4) |
| Interleukin-8(pg/mL) | Immuno-nutrition |
|---|---|
| Median | 7.0 (2.4 to 9.5) |
| Handgrip strength(kg) | Immuno-nutrition |
|---|---|
| Median | 23.8 (17.1 to 27.9) |
| Skeletal muscle mass(kg) | Immuno-nutrition |
|---|---|
| Median | 26.7 (25.3 to 33.6) |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2022 to primary completion in Dec 2022, 2 months.
Results were first posted in Dec 2024, 1 year 11 months after primary completion.
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