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

NCT06380465 | Not Yet Recruiting DMC

• 1 other identifier: 23-11-1838
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Small Vessel Diseases

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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

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

Other: The water extract of "Biang" variety purple sweet potato

Interventions

The water extract of "Biang" variety purple sweet potato OTHER

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

1:1 water extract of purple sweet potato; 1:6 water extract of purple sweet potato

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Universitas Padjadjaran: collaborator
• Institut Pertanian Bogor: collaborator
• School of Science and technology, Kwansei Gakuin University: collaborator

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Taufik Mesiano, MD

  Doctoral Program in Medical Sciences Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taufik Mesiano, MD

CONTACT

+62817811344; taufik.mesiano@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Program, Medical Staff & Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: April 22, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04