Examining how haemodialysis affects salt taste perception in patients

Examining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging

This study tests how haemodialysis affects the way men with kidney issues taste salt, by looking at their brain activity while tasting different salt solutions before and after treatment.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Imperial College London (other)
• Locations: 1 site (London)
• Trial ID: NCT04011254 on ClinicalTrials.gov

What this trial studies

This observational study investigates the impact of haemodialysis on brain activity related to salt taste perception in male patients with varying levels of interdialytic weight gain. Participants will undergo functional MRI scans before and after dialysis while tasting solutions with different salt concentrations. The study aims to identify differences in brain responses to salt taste between patients who can and cannot control weight gain during dialysis. It includes clinical assessments and questionnaires to gather baseline data on salt intake and preferences.

Who should consider this trial

Good fit: Ideal candidates are male haemodialysis patients aged 18-65 with an average interdialytic weight gain greater than 4%.

Not a fit: Patients with diabetes, significant neurological disorders, or those who have undergone bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for salt intake in dialysis patients, potentially reducing health complications associated with excess weight gain.

How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in understanding the relationship between dialysis and dietary preferences.

Eligibility criteria

Inclusion Criteria:

All participants:

* Male
* Aged 18-65 years
* Non-smoker (ex-smokers allowed)
* Right handed (able to use a right handed response button)
* Able to tolerate 1 hour MRI scanning session

For haemodialysis patients:

* Established on haemodialysis for more than 6 months
* Urine output \<200ml/24 hours
* Average (over the past month) interdialytic weight gain:

  1. Main phase 2: \>4 %IDWG
  2. Main phase 3: \<4 or \>4 %IDWG

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Current smoker
* Uncontrolled depression (change in use of anti-depressants in last 3 months, or BDI-II score \>28/63)
* Neurological disorder (Parkinson's disease, serious cerebrovascular disease, epilepsy, moderate-severe traumatic brain injury, dementia)
* Previous bariatric surgery
* Inflammatory state (CRP \>20 on routine dialysis blood tests)
* Acute infective illness
* Significant current or past medical or psychiatric history, or use of medications, that, in the opinion of the Investigators, contraindicates their participation, due to influence on outcome measures.
* Patients lacking capacity or unable to consent and non-English language speakers
* Contra-indication to MRI imaging e.g. metal insert, pacemaker
* Claustrophobia
* Patients currently participating in an active CTIMP trial, or within 4 half-lives of last administration of CTIMP product
* Serious mental illness (e.g. bipolar disorder, schizophrenia)
* Current alcohol or drug dependence

Where this trial is running

London

• Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Eleanor C Sandhu, MBBS — Imperial College London
• Study coordinator: Eleanor C Sandhu, MBBS

Conditions: Dialysis, Excess Interdialytic Weight Gain, salt taste preference, salt taste sensitivity, functional Magnetic Resonance Imaging, Salt taste, salt intake