protocolSection identificationModule nctId: NCT06380465, orgStudyIdInfo id: 23-11-1838, briefTitle: The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, collaborators name: Fakultas Kedokteran Universitas Indonesia, collaborators name: Universitas Padjadjaran, collaborators name: Institut Pertanian Bogor, collaborators name: School of Science and technology, Kwansei Gakuin University, descriptionModule briefSummary: 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., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: The water extract of "Biang" variety purple sweet potato, outcomesModule primaryOutcomes measure: Breath Holding Index, primaryOutcomes measure: Nitric Oxide, primaryOutcomes measure: L-Arginine, primaryOutcomes measure: Adiponectin, primaryOutcomes measure: Cognitive, primaryOutcomes measure: Gait, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-02, uploadDate: 2024-04-18T03:49, filename: ICF_000.pdf, size: 332637, hasResults: False