Chronic Kidney Disease Requiring Chronic DialysisNCT05700851
Immuno-nutrition Supplementation in Haemodialysis
A study testing Immuno-nutrition supplement in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Immuno-nutrition supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Renal Medicine, Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
About this study
Official title: Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
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.
Read the 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.
- Being tested
- Immuno-nutrition supplement
- Keywords
- Haemodialysis, Systemic inflammation, Skeletal muscle mass, Immuno-nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuno-nutrition supplementDietary supplement
Also called Oral Impact®, Nestlé
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Immuno-nutrition supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein - Marker of Systemic Inflammation
C reactive protein levels in mg/L using a high-sensitive laboratory test
Measured: 6 weeks
Interleukin-6 - Marker of Systemic Inflammation
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Measured: 6 weeks
Interleukin-8 - Marker of Systemic Inflammation
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
Measured: 6 weeks
Secondary outcomes (4)
Skeletal Muscle Mass
Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
Measured: 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
Measured: 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
Measured: 6 weeks
Handgrip Strength - a Measure of Muscle Strength
Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start27 Sep 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Maarten Taal, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700851
- Sponsor's protocol ID
- 21085
- Other IDs
- 309937
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2022
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
- ClinicalTrials.gov ID
- NCT05700851
- Acronym / sponsor ID
- 21085
- Keywords
- Haemodialysis, Systemic inflammation, Skeletal muscle mass, Immuno-nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuno-nutrition | Other | Dietary Supplement: Immuno-nutrition supplementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immuno-nutrition supplementAlso: Oral Impact®, NestléOral 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. | Dietary supplement | Immuno-nutrition |
Primary outcome
C Reactive Protein - Marker of Systemic Inflammation
Time frame: 6 weeks
C reactive protein levels in mg/L using a high-sensitive laboratory test
Interleukin-6 - Marker of Systemic Inflammation
Time frame: 6 weeks
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Interleukin-8 - Marker of Systemic Inflammation
Time frame: 6 weeks
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
4 secondary outcomes
Skeletal Muscle Mass
Time frame: 6 weeks
Energy Intake
Time frame: 6 weeks
Protein Intake
Time frame: 6 weeks
Handgrip Strength - a Measure of Muscle Strength
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Taal principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immuno-nutrition supplement in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Reactive Protein - Marker of Systemic Inflammation (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.