Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

Phase 1

Completed

• Conditions: Cerebral Stroke; Oxidative Stress; Malondialdehyde
• Interventions: Drug: Astaxanthine; Drug: Placebo Oral Tablet

• Registration Number: NCT03945526
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-03-23
• Primary Completion: 2010-06-09
• Study Completion: 2010-06-09
• Status Verified: 2019-05
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-09
• Study First Posted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Astaxanthin	Astaxanthine	Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
Control	Placebo Oral Tablet	A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation

Primary Outcome Measures

Name	Time	Method
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry	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	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.

Trial Locations

Locations (1)

Department of Nutrition University of Indonesia; 🇮🇩 Jakarta, Indonesia