Cerebral Small Vessel DiseasesNCT06380465
The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease
A study testing The water extract of "Biang" variety purple sweet potato in people with Cerebral Small Vessel Diseases, run by Universitas Indonesia.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- The water extract of "Biang" variety purple sweet potato
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Closed temporal window on Transcranial Doppler examination
- Acute phase of stroke
- Hepatocellular injury
- Chronic kidney disease
- Intolerance to purple sweet potato
- Aphasia
Show all 9Show fewer
- Neglected
- Visual impairment.
- Undergoing treatment with hormone replacement therapy (HRT), and corticosteroids.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- The water extract of "Biang" variety purple sweet potato
- Keywords
- anthocyanin, purple sweet potato, vasomotor reactivity, cerebral small vessel disease, BHI, nitric oxide, l-arginine, adiponectin, cognitive, gait
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The water extract of "Biang" variety purple sweet potatoOther
Purple sweet potato extract is a mixture of water and "Biang" variety of purple sweet potato puree, enhanced with a touch of flavoring
| Study group | Role | What they receive |
|---|---|---|
| 1:1 water extract of purple sweet potato | Experimental | subjects were blindly and randomly assigned the pure water extract of purple sweet potato for 14 days. The water extract of purple sweet potato with a concentration ratio of 1:1 Receives: Other: The water extract of "Biang" variety purple sweet potato |
| 1:6 water extract of purple sweet potato | Placebo comparator | subjects were blindly and randomly assigned the lower concentration of water extract of purple sweet potato for 14 days. The water extract of purple sweet potato with a concentration ratio of 1:6 Receives: Other: The water extract of "Biang" variety purple sweet potato |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Universitas Padjadjaran, Institut Pertanian Bogor, School of Science and technology, Kwansei Gakuin University
- Responsible party
- Principal investigator, dr.Taufik Mesiano,Sp.S (K), Universitas Indonesia
- Investigators
- Taufik Mesiano, MD, Principal investigator, Doctoral Program in Medical Sciences Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380465
- Sponsor's protocol ID
- 23-11-1838
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06380465
- Acronym / sponsor ID
- 23-11-1838
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- anthocyanin, purple sweet potato, vasomotor reactivity, cerebral small vessel disease, BHI, nitric oxide, l-arginine, adiponectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Universitas Padjadjaran, Institut Pertanian Bogor, School of Science and technology, Kwansei Gakuin University
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1:1 water extract of purple sweet potato | Experimental | Other: The water extract of "Biang" variety purple sweet potatosubjects were blindly and randomly assigned the pure water extract of purple sweet potato for 14 days. The water extract of purple sweet potato with a concentration ratio of 1:1 |
| 1:6 water extract of purple sweet potato | Placebo comparator | Other: The water extract of "Biang" variety purple sweet potatosubjects were blindly and randomly assigned the lower concentration of water extract of purple sweet potato for 14 days. The water extract of purple sweet potato with a concentration ratio of 1:6 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Closed temporal window on Transcranial Doppler examination
- Acute phase of stroke
- Hepatocellular injury
- Chronic kidney disease
- Intolerance to purple sweet potato
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The water extract of "Biang" variety purple sweet potatoPurple sweet potato extract is a mixture of water and "Biang" variety of purple sweet potato puree, enhanced with a touch of flavoring | Other | 1:1 water extract of purple sweet potato, 1:6 water extract of purple sweet potato |
Primary outcome
Breath Holding Index
Time frame: Through study completion, an average of 1 year
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.
Nitric Oxide
Time frame: Through study completion, an average of 1 year
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.
L-Arginine
Time frame: Through study completion, an average of 1 year
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.
Adiponectin
Time frame: Through study completion, an average of 1 year
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.
Cognitive
Time frame: Through study completion, an average of 1 year
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.
Gait
Time frame: Through study completion, an average of 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taufik Mesiano, MD principal investigator
Doctoral Program in Medical Sciences Faculty of Medicine Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A study testing The water extract of "Biang" variety purple sweet potato in people with Cerebral Small Vessel Diseases, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taufik Mesiano, MD (+62817811344, taufik.mesiano@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Holding Index (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.