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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Nitric Oxide
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Able to walk independently with a motor score of at least 4, without proprioceptive disorders or neuropathy.
排除标准
- •Closed temporal window on Transcranial Doppler examination
- •Acute phase of stroke
- •Hepatocellular injury
- •Chronic kidney disease
- •Intolerance to purple sweet potato
- •Neglected
- •Visual impairment.
- •Undergoing treatment with hormone replacement therapy (HRT), and corticosteroids.
结局指标
主要结局
Nitric Oxide
时间窗: 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
时间窗: 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.
Gait
时间窗: 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.
Breath Holding Index
时间窗: 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.
Adiponectin
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
dr.Taufik Mesiano,Sp.S (K)
Doctoral Program, Medical Staff & Lecturer
Indonesia University