Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-31 @ 10:51 PM
Study NCT ID:
NCT05374005
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Excessive Dietary Sodium on Brain Health
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
The Impact of Excessive Dietary Sodium on Brain Health: Examining a Common But Neglected Risk Factor
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: