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The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06380465
Enrollment
90
Registered
2024-04-24
Start date
2024-04-22
Completion date
2025-04-30
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Diseases

Keywords

anthocyanin, purple sweet potato, vasomotor reactivity, cerebral small vessel disease, BHI, nitric oxide, l-arginine, adiponectin, cognitive, gait

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.

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 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.

Interventions

OTHERThe 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

Sponsors

Fakultas Kedokteran Universitas Indonesia
CollaboratorOTHER
Universitas Padjadjaran
CollaboratorOTHER
Institut Pertanian Bogor
CollaboratorOTHER
School of Science and technology, Kwansei Gakuin University
CollaboratorUNKNOWN
Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Breath Holding IndexThrough study completion, an average of 1 yearThe 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.
Nitric OxideThrough study completion, an average of 1 yearNitric 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.
L-ArginineThrough study completion, an average of 1 yearL-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.
AdiponectinThrough study completion, an average of 1 yearAdiponectin 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.
CognitiveThrough study completion, an average of 1 yearThe 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.
GaitThrough study completion, an average of 1 yearThe 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.

Contacts

Primary ContactTaufik Mesiano, MD
taufik.mesiano@ui.ac.id+62817811344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026