Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921084
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-06-01
Brief Title:
MIND Diet to Improve Cognitive Function in Mild Stroke Patients
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
Mediterranean-DASH Intervention for Neurodegenerative Delay MIND Diet to Improve Cognitive Function in Mild Stroke Patients A Pilot Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
MINDICOMS
Brief Summary:
A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay MIND Diet usual medical care versus usual medical care on the rate of cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia
Detailed Description:
Mediterranean-DASH Intervention for Neurodegenerative Delay MIND Diet and Cognitive Decline in Mild Stroke Patients is a 6-month pilot randomized controlled trial designed to test the effects of the MIND diet on cognitive change and several other secondary outcomes among 60 individuals aged 35-70 years without dementia The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022 Specifically the proposed MIND diet will emphasize the consumption of whole grains dark green leafy vegetables dark redyellow vegetables other vegetables berries and citrus poultry fish and seafood beans and legume nuts olive and seed oils and green tea and restrict red and processed meats animal fat fried foods and sweets and pastries The trial will employ a parallel group design comparing the effects on global cognitive change of the MIND intervention diet to usual medical care among 60 mild stroke patients aged 35-70 years Secondary outcomes will include cognitive function changes in several domains brain imaging marker changes dietary behaviour changes daily living behaviour ability changes mental health changes and plasma biomarker changes In addition this trial will examine potential effect mediators and modifiers The proposed study is sited at the BoAo District Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Specialized laboratories will conduct biochemical analyses
Study Oversight
Has Oversight DMC:
None
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?:
None