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| ID | Type | Description | Link |
|---|---|---|---|
| 309937 | Other Identifier | IRAS ID |
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| Name | Class |
|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuno-nutrition | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuno-nutrition supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| C Reactive Protein - Marker of Systemic Inflammation | C reactive protein levels in mg/L using a high-sensitive laboratory test | 6 weeks |
| Interleukin-6 - Marker of Systemic Inflammation | Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay | 6 weeks |
| Interleukin-8 - Marker of Systemic Inflammation | Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Mass | Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Taal | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Renal Medicine, Royal Derby Hospital | Derby | Derbyshire | DE22 3NE | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | C Reactive Protein - Marker of Systemic Inflammation | C reactive protein levels in mg/L using a high-sensitive laboratory test | Posted | Median | Inter-Quartile Range | mg/L | 6 weeks |
|
Reporting/recording of adverse event data was conducted from the baseline assessment until the end of the 6-week intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance to the immuno-nutrition supplement | Gastrointestinal disorders | Non-systematic Assessment | Participant reported vomiting and diarrhoea after 4 days of taking the immuno-nutrition supplement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Maarten Taal | University of Nottingham | 01332224618 | m.taal@nottingham.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2022 | Nov 29, 2024 | Prot_SAP_000.pdf |
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|
| 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 | 6 weeks |
| Handgrip Strength - a Measure of Muscle Strength | Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer | 6 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| C reactive protein | Median | Inter-Quartile Range | mg/L |
|
| Interleukin-6 | Median | Inter-Quartile Range | pg/mL |
|
| Interleukin-8 | Median | Inter-Quartile Range | pg/mL |
|
| Handgrip strength | Median | Inter-Quartile Range | kg |
|
| Skeletal muscle mass | Median | Inter-Quartile Range | kg |
|
| Energy intake | Median | Inter-Quartile Range | kcal/kg of body weight/day |
|
| Protein intake | Median | Inter-Quartile Range | g/kg of body weight/day |
|
|
|
| Primary | Interleukin-6 - Marker of Systemic Inflammation | Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay | Posted | Median | Inter-Quartile Range | pg/mL | 6 weeks |
|
|
|
| Primary | Interleukin-8 - Marker of Systemic Inflammation | Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay | Posted | Median | Inter-Quartile Range | pg/mL | 6 weeks |
|
|
|
| Secondary | Skeletal Muscle Mass | Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment. | 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. | Posted | Median | Inter-Quartile Range | kg | 6 weeks |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | kcal/kg of body weight/day | 6 weeks |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | g/kg of body weight/day | 6 weeks |
|
|
|
| Secondary | Handgrip Strength - a Measure of Muscle Strength | Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer | Handgrip strength was not measured in 2 participants due to arthritis | Posted | Median | Inter-Quartile Range | kg | 6 weeks |
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| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
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