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NCT Number: NCT03945526

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

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.

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Key information

Conditions

Cerebral Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Malondialdehyde Nervous System Diseases Oxidative Stress Stroke Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Nutrition University of Indonesia

Jakarta, 10340, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astaxanthine

Drug

Other names: Astaxanthine 8mg

Placebo oral tablet

Drug

Other names: Astaxanthine placebo

Primary outcomes

  1. Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry

    Time frame: 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).

  2. National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 10, 2019
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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