Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06380465
Other study ID # 23-11-1838
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 22, 2024
Est. completion date April 30, 2025

Study information

Verified date April 2024
Source Indonesia University
Contact Taufik Mesiano, MD
Phone +62817811344
Email taufik.mesiano@ui.ac.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 groups/arms 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 participant's 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 25.0.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - CSVD patients aged 40-65 years. - CSVD patients have been diagnosed by MRI. - Willing to participate in the study and signed the consent letter after being given informed consent. - Have a Montreal Cognitive Assessment score of at least 26. - Able to walk independently with a motor score of at least 4, without proprioceptive disorders or neuropathy. Exclusion Criteria: - Closed temporal window on Transcranial Doppler examination - Acute phase of stroke - Hepatocellular injury - Chronic kidney disease - Intolerance to purple sweet potato - Aphasia - Neglected - Visual impairment. - Undergoing treatment with hormone replacement therapy (HRT), and corticosteroids.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The water extract of "Biang" variety purple sweet potato
Purple sweet potato extract is a mixture of water and "Biang" variety of purple sweet potato puree, enhanced with a touch of flavoring

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Indonesia University Fakultas Kedokteran Universitas Indonesia, Institut Pertanian Bogor, School of Science and technology, Kwansei Gakuin University, Universitas Padjadjaran

Outcome

Type Measure Description Time frame Safety issue
Primary Breath Holding Index The assessment will be conducted by a Neurologist who has special expertise in neurosonology using Transcranial Doppler.
The outcome of this study is to find out the difference in scores from pre-intervention and post-intervention.
Through study completion, an average of 1 year
Primary Nitric Oxide Nitric Oxide will be measured in plasma using Total Nitric Oxide and Nitrate/Nitrite Parameter Assay Kit.
The outcome of this study is to find out the difference in concentration from pre-intervention and post-intervention.
Through study completion, an average of 1 year
Primary L-Arginine L-arginine will be measured in plasma using L- Arginine Assay Kit (Colorimetry) The outcome of this study is to find out the difference in concentration from pre-intervention and post-intervention. Through study completion, an average of 1 year
Primary Adiponectin Adiponectin will be measured in serum using Human Total Adiponectin/Acrp30 Quantikine ELISA Kit The outcome of this study is to find out the difference in concentration from pre-intervention and post-intervention. Through study completion, an average of 1 year
Primary Cognitive The subjects will take a cognitive function test, namely Trail Making Test (TMT) A and Trail Making Test (TMT) B.
The TMT-A test consists of combining numbers from 1 to 25, while the TMT-B test consists of alternating numbers and letters. TMT A and B are scored based on how long it takes to complete the test. This study is to find out the difference in scores from pre-intervention and post-intervention.
Through study completion, an average of 1 year
Primary Gait The Timed Up and Go (TUG) test examination included assessment of the patient's balance, gait speed, and functional capacity. The TUG test assessment consisted of the subject standing up from a chair (chair height 46 cm, chair armrest height 65 cm), walking 3 meters, turning around, and walking 3-meters back to the chair and sitting down, at a spontaneous gait speed. The time taken to perform the test was measured using a stopwatch. The time recorded on the STANDARDIZED stopwatch was the TUG score. Through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04041349 - Clinical Observation for the Therapeutic Effect of mNGF on Cognitive Decline in Cerebral Small Vessel Disease Phase 4
Recruiting NCT04109963 - Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment Phase 2
Not yet recruiting NCT06416371 - Retinal Vessel Leakage in Cerebral Small Vessel Disease
Not yet recruiting NCT05967728 - Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care Phase 2
Completed NCT05714813 - Circuit Training and Retina N/A
Not yet recruiting NCT06077305 - A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke
Not yet recruiting NCT06061692 - Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study(TOPS-CSVD) Phase 4
Recruiting NCT04962295 - China Imaging-based Biobank of Cerebral Small Vessal Diseases
Completed NCT02801032 - Effect of Tadalafil on Cerebral Large Arteries in Stroke Phase 2
Not yet recruiting NCT05594966 - Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium
Terminated NCT02890888 - Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease N/A
Recruiting NCT04318119 - Cerebral Small Vessel Disease Registry Study
Recruiting NCT03906123 - The Efficacy of DL-NBP in Patients With Mild Subcortical Ischemic Vascular Dementia N/A
Recruiting NCT05306834 - Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease N/A
Not yet recruiting NCT05583266 - Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Disease(PERFORM) Phase 4
Recruiting NCT05173896 - Improving Cerebral Blood Flow and Cognition in Patients With Cerebral Small Vessel Disease. The ETLAS-2 Trial Phase 2
Recruiting NCT01688505 - Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function N/A
Recruiting NCT01819441 - Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients Phase 4
Recruiting NCT04330222 - Cambridge 7 Tesla Cerebral Small Vessel Disease Study
Recruiting NCT04298866 - White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI N/A