Cerebral Small Vessel DiseaseNCT05374005
The Impact of Excessive Dietary Sodium on Brain Health
An observational study of Cerebral Small Vessel Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Sporadic cerebral small vessel disease (CSVD) is not only the most common subtype of vascular dementia, in recent multi-center study showed that sporadic CSVD harbors in a third of Alzheimer's disease (AD) patients in 9 Asian regions. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Disease
- How many people
- 220 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jun 2022to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject with cSVD will be recruited at stroke unit and neurology clinic at Prince of Wales Hospital. Healthy volunteers will recruited through other community cohorts.
Who may be able to join
- Chinese ethnicity,
- age between 55 and 80-year-old, and
- a primary language of Cantonese.
- Extra inclusion criteria for CSVD group:
- Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
- Modified Functional Ambulation Classification 5 or above;
- Montreal Cognitive Assessment (MoCA) score < 25;
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, N.T., 00000
Pauline Kwan, MSoSc, 26352160, paulinekwan@cuhk.edu.hk
About this study
Official title: The Impact of Excessive Dietary Sodium on Brain Health: Examining a Common But Neglected Risk Factor
Sporadic cerebral small vessel disease (CSVD) is not only the most common subtype of vascular dementia, in recent multi-center study showed that sporadic CSVD harbors in a third of Alzheimer's disease (AD) patients in 9 Asian regions. The CSVD increases the severity of cognitive impairment in these patients and has an etiological contribution to the development of AD. Studies demonstrated that CSVD is more prevalent in Chinese than in Australians and this association was independent of traditional vascular risk factors (e.g. hypertension). Other factors such as lifestyle, environmental or genetic factors may explain this difference. Although hypertension is an important cause for CSVD, it only accounts for a small proportion of the variance in CSVD. Irrespective of the cause, it is currently believed that endothelial dysfunction of CSVD is the key pathophysiological mechanism of CSVD. Having an effective treatment of CSVD will have an enormous impact on the prevention of dementia.
Excessive dietary sodium is an established risk factor for cardiovascular diseases, including stroke. It is traditionally linked to its effects in raising blood pressure. The Department of Health advocated reducing salt intake for the prevention of hypertension, coronary heart disease, and stroke.
Read more
However, recent epidemiological studies suggest that it may have a direct effect on cardiovascular diseases independent of blood pressure. A recent animal study showed that excessive dietary sodium-induced cerebral endothelial dysfunction, resulting in cognitive impairment. Interestingly, endothelial dysfunction was related to an adaptive immune response in the gut. A clinical study conducted in the United Kingdom suggested excessive dietary sodium intake may promote CSVD
A clinical study conducted in the United Kingdom suggested excessive dietary sodium intake may promote CSVD by increasing WMH volume in the brain, independent of its effects on blood pressure. Notably, a few animal studies showed that the association between high dietary sodium and worse cognitive function in the absence of blood pressure changes. This pinpoints the important role of dietary sodium as an independent contributor to brain health and cognition.
This study aims to assess the association between dietary sodium, neuroimaging measures, and cognition in cerebral small vessel disease and controls during the 18-month follow-up.
Read the detailed description
This study hypothesis that high dietary sodium is associated with CSVD-related neuroimaging measures such as reduced white matter hyperintensities, total brain volume, and white matter structural integrity. The second hypothesis is that high dietary sodium is associated with worse cognitive function. These associations may be more prominent in the CSVD group compared to the control group and is independent of blood pressure.
Subjects with severe CSVD (n =110) and healthy controls (n =110) will be recruited.
2 trials of 24 hour urine will be collected at baseline visit and 2 trials of 24 hour urine will be collected at 18 months.
Clinical assessment (e.g. mood, cognition, physical activities, gait etc.) will be assessed at baseline and 18 months.
2 trials of Brain MRI will be conducted at baseline and 18 month visit
- Conditions
- Cerebral Small Vessel Disease
- Keywords
- CSVD
- Medical subject headings
- Cerebral Small Vessel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of level of urinary sodium
24 hours of urine will be collected to measure the level of sodium
The higher the sodium level the worse the outcome
Measured: Baseline and 18 month
Change of Gait
Gait velocity will be assessed using the 8-meter walking time. Time for walking 8-m will be measured by a stopwatch. The faster of two trials will be used in the analysis
The faster of the walking time the better outcome.
Measured: Baseline and 18 month
Change of balance
Single leg stance time will be measured by asking participants, with their hands on their hips, to balance as long as possible on one leg with an upper limit of 30 seconds. Two trials for each leg will be performed. The best time of the four trials will be used for analysis. The longer the time duration the better outcome.
Measured: Baseline and 18 month
Change of Hong Kong MOntreal Cognitive Assessment
Hong Kong MOntreal Cognitive Assessment (HK-MoCA) is a cognitive assessmenttool. Score from 0 to 30 . The lower score reflect the worse the outcome.
Measured: Baseline and 18 month
Change of The Chinese Geriatric Depression Scale 30
The Chinese Geriatric Depression Scale is used to detect depressive mood. Score 0 to 30. The higher the score, the worse the outcome
Measured: Baseline and 18 month
Change of Pittsburgh sleep quality index
Pittsburgh sleep quality index Chinese Version is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire contains frequency questions related to sleep quality, each question scale from 0 to 3. The higher the score, the worse the outcome. There is no total score available for this assessment
Measured: Baseline and 18 month
Change of Hong Kong List Learning Test
Hong Kong List Learning Test is memory test in Chinese designed for the assessment of the processes and organizational strategies involved in learning verbal information. The more negative the standard deviation the worse the outcome
Measured: Baseline and 18 month
Food frequency questionnaire
The food frequency questionnaire serves the purpose of understanding the type of food that subject frequently consume in the past 12 months.
There is no total score for this assessment. There is no positive and negative outcome available
Measured: Baseline
Food frequency questionnaire
The food frequency questionnaire serves the purpose of understanding the type of food that subject frequently consume in the past 12 months.
There is no total score for this assessment. There is no positive and negative outcome available
Measured: 18 month
24 hour food intake
The 24 hour food intake serves the purpose of understanding the food that subject consume on the day of urine collection
There is no positive and negative outcome available
Measured: Baseline
24 hour food intake
The 24 hour food intake serves the purpose of understanding the food that subject consume on the day of urine collection
There is no positive and negative outcome available
Measured: 18 Month
Change of creatinine in urine
24 hours of urine will be collected to measure the level of creatinine
The higher the creatinine level the worse the outcome
Measured: Baseline and 18 month
change of urinary potassium
24 hours of urine will be collected to measure the level of potassium
The higher the potassium level the worse the outcome
Measured: Baseline and 18 month
Change of International Physical Activity Questionnaire
the International Physical Activity Questionnaire is a self report assessment to investigate the daily activities (frequency, duration, and level) of subject within the 7 days prior assessment
There is no total score available for this questionnaire. The higher duration and frequency and level of daily activities the better outcome
Measured: Baseline and 18 month
Change of Brain Peak Width of Skeletonized Mean Diffusivity
Peak Width of Skeletonized Mean Diffusivity is a robust, fully-automated and easy-to-implement marker for cerebral small vessel disease based on diffusion tensor imaging, white matter tract skeletonization and histogram analysis. It is a biomarker for brain MRI images.
Measured: Baseline and 18 month
Secondary outcomes (1)
Change of 24 hour blood pressure monitoring
Systolic and diastolic blood pressure will be measured using the 24-hour ambulatory blood pressure monitor. blood pressure will be measured at the same 24-hour period as urine measurement as blood
Measured: Baseline and 18 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start22 Jun 2022
- Primary completion1 May 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnie Yin Ka LAM, Chinese University of Hong Kong
- Investigators
- Bonnie Yin Ka Lam, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374005
- Sponsor's protocol ID
- 2022.147
- Status last verified
- Feb 2024
- First submitted
- 10 May 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Excessive Dietary Sodium on Brain Health: Examining a Common But Neglected Risk Factor
- ClinicalTrials.gov ID
- NCT05374005
- Acronym / sponsor ID
- 2022.147
- Conditions
- Cerebral Small Vessel Disease
- Keywords
- CSVD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 13 May 2022 (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.
Sporadic cerebral small vessel disease (CSVD) is not only the most common subtype of vascular dementia, in recent multi-center study showed that sporadic CSVD harbors in a third of Alzheimer's disease (AD) patients in 9 Asian regions. The CSVD increases the severity of cognitive impairment in these patients and has an etiological contribution to the development of AD. Studies demonstrated that CSVD is more prevalent in Chinese than in Australians and this association was independent of traditional vascular risk factors (e.g. hypertension). Other factors such as lifestyle, environmental or genetic factors may explain this difference. Although hypertension is an important cause for CSVD, it only accounts for a small proportion of the variance in CSVD. Irrespective of the cause, it is currently believed that endothelial dysfunction of CSVD is the key pathophysiological mechanism of CSVD. Having an effective treatment of CSVD will have an enormous impact on the prevention of dementia.
Excessive dietary sodium is an established risk factor for cardiovascular diseases, including stroke. It is traditionally linked to its effects in raising blood pressure. The Department of Health advocated reducing salt intake for the prevention of hypertension, coronary heart disease, and stroke.
However, recent epidemiological studies suggest that it may have a direct effect on cardiovascular diseases independent of blood pressure. A recent animal study showed that excessive dietary sodium-induced cerebral endothelial dysfunction, resulting in cognitive impairment. Interestingly, endothelial dysfunction was related to an adaptive immune response in the gut. A clinical study conducted in the United Kingdom suggested excessive dietary sodium intake may promote CSVD
A clinical study conducted in the United Kingdom suggested excessive dietary sodium intake may promote CSVD by increasing WMH volume in the brain, independent of its effects on blood pressure. Notably, a few animal studies showed that the association between high dietary sodium and worse cognitive function in the absence of blood pressure changes. This pinpoints the important role of dietary sodium as an independent contributor to brain health and cognition.
This study aims to assess the association between dietary sodium, neuroimaging measures, and cognition in cerebral small vessel disease and controls during the 18-month follow-up.
Detailed description
This study hypothesis that high dietary sodium is associated with CSVD-related neuroimaging measures such as reduced white matter hyperintensities, total brain volume, and white matter structural integrity. The second hypothesis is that high dietary sodium is associated with worse cognitive function. These associations may be more prominent in the CSVD group compared to the control group and is independent of blood pressure.
Subjects with severe CSVD (n =110) and healthy controls (n =110) will be recruited.
2 trials of 24 hour urine will be collected at baseline visit and 2 trials of 24 hour urine will be collected at 18 months.
Clinical assessment (e.g. mood, cognition, physical activities, gait etc.) will be assessed at baseline and 18 months.
2 trials of Brain MRI will be conducted at baseline and 18 month visit
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with cSVD will be recruited at stroke unit and neurology clinic at Prince of Wales Hospital. Healthy volunteers will recruited through other community cohorts.
Key inclusion criteria (7 listed)
- Chinese ethnicity,
- age between 55 and 80-year-old, and
- a primary language of Cantonese.
- Extra inclusion criteria for CSVD group:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of level of urinary sodium
Time frame: Baseline and 18 month
24 hours of urine will be collected to measure the level of sodium The higher the sodium level the worse the outcome
Change of Gait
Time frame: Baseline and 18 month
Gait velocity will be assessed using the 8-meter walking time. Time for walking 8-m will be measured by a stopwatch. The faster of two trials will be used in the analysis The faster of the walking time the better outcome.
Change of balance
Time frame: Baseline and 18 month
Single leg stance time will be measured by asking participants, with their hands on their hips, to balance as long as possible on one leg with an upper limit of 30 seconds. Two trials for each leg will be performed. The best time of the four trials will be used for analysis. The longer the time duration the better outcome.
Change of Hong Kong MOntreal Cognitive Assessment
Time frame: Baseline and 18 month
Hong Kong MOntreal Cognitive Assessment (HK-MoCA) is a cognitive assessmenttool. Score from 0 to 30 . The lower score reflect the worse the outcome.
Change of The Chinese Geriatric Depression Scale 30
Time frame: Baseline and 18 month
The Chinese Geriatric Depression Scale is used to detect depressive mood. Score 0 to 30. The higher the score, the worse the outcome
Change of Pittsburgh sleep quality index
Time frame: Baseline and 18 month
Pittsburgh sleep quality index Chinese Version is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire contains frequency questions related to sleep quality, each question scale from 0 to 3. The higher the score, the worse the outcome. There is no total score available for this assessment
Change of Hong Kong List Learning Test
Time frame: Baseline and 18 month
Hong Kong List Learning Test is memory test in Chinese designed for the assessment of the processes and organizational strategies involved in learning verbal information. The more negative the standard deviation the worse the outcome
Food frequency questionnaire
Time frame: Baseline
The food frequency questionnaire serves the purpose of understanding the type of food that subject frequently consume in the past 12 months. There is no total score for this assessment. There is no positive and negative outcome available
Food frequency questionnaire
Time frame: 18 month
The food frequency questionnaire serves the purpose of understanding the type of food that subject frequently consume in the past 12 months. There is no total score for this assessment. There is no positive and negative outcome available
24 hour food intake
Time frame: Baseline
The 24 hour food intake serves the purpose of understanding the food that subject consume on the day of urine collection There is no positive and negative outcome available
24 hour food intake
Time frame: 18 Month
The 24 hour food intake serves the purpose of understanding the food that subject consume on the day of urine collection There is no positive and negative outcome available
Change of creatinine in urine
Time frame: Baseline and 18 month
24 hours of urine will be collected to measure the level of creatinine The higher the creatinine level the worse the outcome
change of urinary potassium
Time frame: Baseline and 18 month
24 hours of urine will be collected to measure the level of potassium The higher the potassium level the worse the outcome
Change of International Physical Activity Questionnaire
Time frame: Baseline and 18 month
the International Physical Activity Questionnaire is a self report assessment to investigate the daily activities (frequency, duration, and level) of subject within the 7 days prior assessment There is no total score available for this questionnaire. The higher duration and frequency and level of daily activities the better outcome
Change of Brain Peak Width of Skeletonized Mean Diffusivity
Time frame: Baseline and 18 month
Peak Width of Skeletonized Mean Diffusivity is a robust, fully-automated and easy-to-implement marker for cerebral small vessel disease based on diffusion tensor imaging, white matter tract skeletonization and histogram analysis. It is a biomarker for brain MRI images.
1 secondary outcome
Change of 24 hour blood pressure monitoring
Time frame: Baseline and 18 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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.
Bonnie Yin Ka Lam, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline Kwan, Master (+852 26352160, paulinekwan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of level of urinary sodium (time frame: Baseline and 18 month). The study lists 15 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 15 Feb 2024.