Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
研究概览
简要总结
This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.
详细描述
There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.
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
- Single (Participant)
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
- •40-65 years old
- •Has acute ischemic stroke with an onset of less than 48 hours before hospital admission
- •NIHSS score of less than or equal to 15
- •Can consume food orally or enterally
- •Has given their consent to be a participant in the study
排除标准
- •Renal failure
- •Liver failure
- •Is taking supplements other than his or her main stroke medications
- •Has taken antioxidant supplements in the last 3 months before stroke onset
研究组 & 干预措施
Astaxanthin
Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
干预措施: Astaxanthine (Drug)
Control
A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
时间窗: 7 days
This method used Thiobarbituric acid reaction (TBAR) with substances such as malondialdehyde. The scale was 0.367 nmol/ml-0.707 nmol/ml. The value above 0.707nmol/ml would be the worse outcome, and value less than 0.367nmol/ml would be the best outcome. Bivariate analysis was used to analyze the results (T-test or the Mann-Whitney Test).
National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients
时间窗: 7 days
Score scale was 4-15, where less than 4 indicates mild neurologic deficit, 4-15 moderate neurologic deficit, and more than 15 severe neurologic deficit. They will be assessed before and after the trial to compare how each participant improved after given the intervention.
次要结局
未报告次要终点
研究者
Gabriella Nurahmani Putri
Assistant Clinical Nutrition Professor
Indonesia University