CachexiaMMIEADNCT07107087
A Multimodal Integrated Intervention for Kidney Cachexia
A study testing Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) in people with Cachexia and CKD, run by Queen's University, Belfast at 2 sites in United Kingdom.
Trial summary
This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators. Patients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- CKD Stage 5 patients receiving maintenance HD therapy for >3 months
- Oedema-free weight loss of at least 5% in 12 months or BMI less than 20 kg/m2
- Self-reported decreased physical function/muscle strength and appetite, increased fatigue
- Male or female, aged >18 years and
- Able to provide written informed consent.
Who cannot join
- Under 18 years of age
- Patients within 3 months of initiation of HD (patients in this time frame are generally less clinically stable, many having vascular access procedures performed and with much higher rates of intercurrent events, including death and hospitalisation)
- Patients experiencing weight loss due to clinically explainable reasons for example malabsorption or oesophageal blockage
- Patients already receiving chronic anticoagulation therapy or with a history of bleeding with 3 months/active bleeding issues
- Patients receiving immunosuppressants or immunomodulators
- Patients who are pregnant or breast feeding
Show all 16Show fewer
- Patients with a hypersensitivity to any of the constituent components of the omega-3 dietary supplement
- Patients who have dementia, a psychiatric disorder (who are not treated and stable) or a severe cognitive impairment which would deem them unable to give informed consent
- Patients with expected survival on dialysis of <6 months [e.g. those with severe heart failure (New York Heart Association ≥3)]
- Patients for whom dialysis withdrawal is being considered
- Patients likely to receive a live-donor transplant or transfer to peritoneal dialysis during the study duration
- Patients with bilateral lower limb amputations
- Patients deemed to be clinically unstable by their treating physician
- Patients who are non-English speaking (not having the ability to provide informed consent, read and write English)
- Patients who are currently enrolled in any study which involves exercise, fish oil/omega-3 or have been taking fish oil or omega-3 supplementation in the previous 3 months
- Patients who are not able/willing to be involved.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Northern Health and Social Care Trust
Antrim, County Antrim, BT41 2RL
Robert Mullan, +44 028 9442 4472, Robert.Mullan@northerntrust.hscni.net
- Recruiting
South Eastern Health and Social Care Trust
Belfast, County DOWN, BT16 1RH
Alastair Woodman, +44 28 9056 4839, Alastair.Woodman@setrust.hscni.net
About this study
Official title: Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) for Kidney Cachexia: a Mixed-methods Feasibility Cluster Randomised Controlled Trial and Process Evaluation
This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators. Patients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalisation and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). The investigators want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia. Patients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \& Dietary advice plus routine care) and two have been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. The investigators will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, the investigators will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, the investigators will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.
- Being tested
- Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)Other
In addition to their standard care, the intervention group will receive MMIEAD - an individualised exercise programme, oral omega-3 supplementation and dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (MMIEAD + standard care) | Experimental | Individualised exercise programme:
Participants will receive an exercise handbook and exercise diary to complete for a 12-week progressive home-based training programme (aerobic and resistance training). The intradialytic component will be an optional supervised 30-minute session up to 3 times per week.
Dietary advice:
Each patient in the intervention group will receive a 60-minute personalised dietetic assessment. Patients will be reviewed by the dietician at the start of the intervention and at 6-weeks and 12-weeks. Patients will also complete a 3-day food diary on five occasions throughout the 12 weeks of the interventions (weeks 1,3,6,9,12).
Oral omega-3 supplement:
Each patient will receive a 12-week supply of omega-3 oral capsules using a daily dose (1000mg twice daily) which has a proven safety profile, tolerability.
Weekly contact:
Patients in the intervention arm, will be contacted weekly (or more if preferred) by telephone. An adherence to MMIEAD log will be completed. Receives: Other: Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) |
| Control arm (standard care) | No intervention | Patients in the control arm will not be offered the MMIEAD intervention. All study sites have been surveyed to ensure the intervention components are not provided in standard care. Patients who have been allocated to the control group will be advised to adhere to routine standard care throughout the study. As the recruitment sites cover four Trusts, a description of standard care per Trust will be collected as part of the process evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment; measured as the number of fully enrolled patients as a proportion of approached eligible individuals
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startSep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Reid, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107087
- Sponsor's protocol ID
- B25/11
- Acronym
- MMIEAD
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reid J, Blair C, Slee A, McKeaveney C, Maxwell AP, Adell V, Carson M, Awan F, Brown M, Davenport A, Fogarty D, Fouque D, Gooding O, McKinley T, Hagan S, Hutchinson C, Kalantar-Zadeh K, Magee K, Mullan R, Morgan N; NICRN Clinical Research Team; Noble H, Porter S, Seres DS, Shields J, Swaine I, Witham M. Multi-modal integrated intervention combining exercise, anti-inflammatory, and dietary advice (MMIEAD) for adults with kidney cachexia: protocol for a mixed-methods feasibility cluster randomised controlled trial and process evaluation. Pilot Feasibility Stud. 2026 Feb 19;12(1):43. doi: 10.1186/s40814-026-01784-z.
PubMed 41715172
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) for Kidney Cachexia: a Mixed-methods Feasibility Cluster Randomised Controlled Trial and Process Evaluation
- ClinicalTrials.gov ID
- NCT07107087
- Acronym / sponsor ID
- MMIEAD / B25/11
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators. Patients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalisation and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). The investigators want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia. Patients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \& Dietary advice plus routine care) and two have been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. The investigators will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, the investigators will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, the investigators will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (MMIEAD + standard care) | Experimental | Other: Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)Individualised exercise programme: Participants will receive an exercise handbook and exercise diary to complete for a 12-week progressive home-based training programme (aerobic and resistance training). The intradialytic component will be an optional supervised 30-minute session up to 3 times per week. Dietary advice: Each patient in the intervention group will receive a 60-minute personalised dietetic assessment. Patients will be reviewed by the dietician at the start of the intervention and at 6-weeks and 12-weeks. Patients will also complete a 3-day food diary on five occasions throughout the 12 weeks of the interventions (weeks 1,3,6,9,12). Oral omega-3 supplement: Each patient will receive a 12-week supply of omega-3 oral capsules using a daily dose (1000mg twice daily) which has a proven safety profile, tolerability. Weekly contact: Patients in the intervention arm, will be contacted weekly (or more if preferred) by telephone. An adherence to MMIEAD log will be completed. |
| Control arm (standard care) | No intervention | –Patients in the control arm will not be offered the MMIEAD intervention. All study sites have been surveyed to ensure the intervention components are not provided in standard care. Patients who have been allocated to the control group will be advised to adhere to routine standard care throughout the study. As the recruitment sites cover four Trusts, a description of standard care per Trust will be collected as part of the process evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CKD Stage 5 patients receiving maintenance HD therapy for >3 months
- Oedema-free weight loss of at least 5% in 12 months or BMI less than 20 kg/m2
- Self-reported decreased physical function/muscle strength and appetite, increased fatigue
- Male or female, aged >18 years and
- Able to provide written informed consent.
Key exclusion criteria (16 listed)
- Under 18 years of age
- Patients within 3 months of initiation of HD (patients in this time frame are generally less clinically stable, many having vascular access procedures performed and with much higher rates of intercurrent events, including death and hospitalisation)
- Patients experiencing weight loss due to clinically explainable reasons for example malabsorption or oesophageal blockage
- Patients already receiving chronic anticoagulation therapy or with a history of bleeding with 3 months/active bleeding issues
- Patients receiving immunosuppressants or immunomodulators
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 |
|---|---|---|
| Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)In addition to their standard care, the intervention group will receive MMIEAD - an individualised exercise programme, oral omega-3 supplementation and dietary advice. | Other | Intervention arm (MMIEAD + standard care) |
Primary outcome
Recruitment; measured as the number of fully enrolled patients as a proportion of approached eligible individuals
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 41715172Reid J, Blair C, Slee A, McKeaveney C, Maxwell AP, Adell V, Carson M, Awan F, Brown M, Davenport A, Fogarty D, Fouque D, Gooding O, McKinley T, Hagan S, Hutchinson C, Kalantar-Zadeh K, Magee K, Mullan R, Morgan N; NICRN Clinical Research Team; Noble H, Porter S, Seres DS, Shields J, Swaine I, Witham M. Multi-modal integrated intervention combining exercise, anti-inflammatory, and dietary advice (MMIEAD) for adults with kidney cachexia: protocol for a mixed-methods feasibility cluster randomised controlled trial and process evaluation. Pilot Feasibility Stud. 2026 Feb 19;12(1):43. doi: 10.1186/s40814-026-01784-z.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) in people with Cachexia and CKD, run by Queen's University, Belfast at 2 sites 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Reid, PhD (02890972459, j.reid@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment; measured as the number of fully enrolled patients as a proportion of approached eligible individuals (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07107087, which also lists 1 linked publication.
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 26 Aug 2026.