Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380465
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Anthocyanin Intake From Purple Sweet Potato on Vasomotor Reactivity of Intracranial Vessels in Cerebral Small Vessel Disease - a Study of Breath-Holding Index Nitric Oxide L-Arginine Adiponectin Cognitive and Gait
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Cerebral small vessel disease CSVD is a major cause of disability cognitive impairment and functional loss in the elderly CSVD occurs due to damage to arterioles capillaries and venules in the brain parenchyma and can cause clinical and neuroimaging symptoms CSVD also accounts for up to 25 of all ischemic stroke cases and making it the second leading cause of death in the world after ischemic heart disease
Purple sweet potatoes scientifically known as Ipomoea batatas L Lam contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant anti-inflammatory and potentially phytoestrogenic activity These anthocyanins have been linked to a reduced risk of obesity diabetes and high cholesterol They also show potential in improving endothelial function thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways gene expression and protein function at the molecular level In addition to their ability to enhance vascular flow anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo
The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler Nitric Oxide L-Arginine and Adiponectin levels in blood Cognitive Test and Gait
Purple sweet potatoes scientifically known as Ipomoea batatas L Lam contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant anti-inflammatory and potentially phytoestrogenic activity These anthocyanins have been linked to a reduced risk of obesity diabetes and high cholesterol They also show potential in improving endothelial function thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways gene expression and protein function at the molecular level In addition to their ability to enhance vascular flow anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo
The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler Nitric Oxide L-Arginine and Adiponectin levels in blood Cognitive Test and Gait
Detailed Description:
The aim of this clinical trial is to evaluate the effectiveness of anthocyanins found in purple sweet potatoes as a functional food in individuals with CSVD It is also hoped that anthocyanins could enhance the vasomotor reactivity of intracranial vessels in individuals with CSVD Additionally purple sweet potatoes may influence CSVD laboratory parameters as well as functional gait and cognitive function
The whole procedure will run for 16 days divided into 3 parts Pre-intervention Intervention and Post-intervention
The participant will come in day 1 and 16 Pre-intervention day 1 to conduct screening provide informed consent and also baseline assessment
Intervention day 2-15 involves consuming purple sweet potato extract 250 ml twice daily with daily delivery to maintain freshness Additionally patients will undergo a food recall assessment once on a weekday and twice on weekends
Post-intervention day 16 for continued outcome assessment
The total number of visits from each participant is 2 times The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groupsarms consisting of 2 treatments 1 group getting the water extract pf purple sweet potato and 1 control group that got placebo The daily food intake will be recorded by 3 days food diary-24 hours recall method The research team will contact the participant on 2 weekdays and 1 weekend day The participants regular medications will still be taken and recorded prior to the intervention
Any unwanted event adverse event that occurs will be recorded If an undesirable event occurs a written report will be made to the ethics committee
Demographic data will be presented descriptively according to the type of data Univariate descriptive analysis will be used to provide an overview of the data Data distribution test will be conducted using Kolmogorov-Smirnov If the data is normally distributed the t-test will be used otherwise the Wilcoxon test will be used Data analysis will be carried out using SPSS 250
The whole procedure will run for 16 days divided into 3 parts Pre-intervention Intervention and Post-intervention
The participant will come in day 1 and 16 Pre-intervention day 1 to conduct screening provide informed consent and also baseline assessment
Intervention day 2-15 involves consuming purple sweet potato extract 250 ml twice daily with daily delivery to maintain freshness Additionally patients will undergo a food recall assessment once on a weekday and twice on weekends
Post-intervention day 16 for continued outcome assessment
The total number of visits from each participant is 2 times The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groupsarms consisting of 2 treatments 1 group getting the water extract pf purple sweet potato and 1 control group that got placebo The daily food intake will be recorded by 3 days food diary-24 hours recall method The research team will contact the participant on 2 weekdays and 1 weekend day The participants regular medications will still be taken and recorded prior to the intervention
Any unwanted event adverse event that occurs will be recorded If an undesirable event occurs a written report will be made to the ethics committee
Demographic data will be presented descriptively according to the type of data Univariate descriptive analysis will be used to provide an overview of the data Data distribution test will be conducted using Kolmogorov-Smirnov If the data is normally distributed the t-test will be used otherwise the Wilcoxon test will be used Data analysis will be carried out using SPSS 250
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