Examining how high dietary sodium affects brain health in older adults

The Impact of Excessive Dietary Sodium on Brain Health: Examining a Common But Neglected Risk Factor

This study is trying to see if eating too much salt affects brain health and thinking skills in older adults, comparing those with brain issues to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 220 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Shatin, N.t.)
• Trial ID: NCT05374005 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between excessive dietary sodium intake and cerebral small vessel disease (CSVD) in older adults. It aims to determine if high sodium levels are linked to neuroimaging changes, such as white matter hyperintensities and brain volume, as well as cognitive decline. The study will recruit 220 participants, including 110 with severe CSVD and 110 healthy controls, and will involve urine collection and brain MRI assessments at baseline and after 18 months. The findings could provide insights into dietary influences on brain health and dementia risk.

Who should consider this trial

Good fit: Ideal candidates are Chinese individuals aged 55 to 80 who speak Cantonese and have been diagnosed with severe CSVD.

Not a fit: Patients with conditions such as hypernatremia, renal failure, or other significant neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to dietary recommendations that help prevent or mitigate cognitive decline in older adults.

How similar studies have performed: While the relationship between dietary sodium and brain health is being explored, this specific approach focusing on CSVD in the Chinese population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Chinese ethnicity,
* age between 55 and 80-year-old, and
* a primary language of Cantonese.
* Extra inclusion criteria for CSVD group:

  1. Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
  2. Modified Functional Ambulation Classification 5 or above;
  3. Montreal Cognitive Assessment (MoCA) score \< 25;

Exclusion Criteria:

* Hypernatremia (Na \>146mmol/L) or hyponatremia (Na \<134 mmol/L) from screening blood test;
* With sodium supplement;
* Renal failure (stage 4 \& 5) with glomerular filtration rate \< 29;
* performed cardiac surgery or neurosurgery, with cardiac failure;
* Had major psychiatric diseases
* Contraindications for MRI.
* Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ;
* Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.\|
* Contraindication to proposed imaging, e.g. chronic kidney disease (KDNIGO) stage 4 or above, acute kidney injury, hypersensitivity to gadolinium-based contrast, non-MRI conditional implants or prosthesis
* Medical condition that would not allow the patient to adhere to the protocol or complete the study.;
* Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);
* Pregnancy.

Where this trial is running

Shatin, N.t.

• Prince of Wales Hospital — Shatin, N.t., Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Bonnie Yin Ka Lam, PhD — Chinese University of Hong Kong
• Study coordinator: Pauline Kwan, Master

Conditions: Cerebral Small Vessel Disease, CSVD