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

April 18, 2024 updated by: dr.Taufik Mesiano,Sp.S (K), Indonesia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1:1 water extract of purple sweet potato
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
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
Placebo Comparator: 1:6 water extract of purple sweet potato
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitas Padjadjaran
Fakultas Kedokteran Universitas Indonesia
Institut Pertanian Bogor
School of Science and technology, Kwansei Gakuin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taufik Mesiano, MD, Doctoral Program in Medical Sciences Faculty of Medicine Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-11-1838

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings