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

Oxidative Stress Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945526
• Other study ID #: Neuronutrition
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2010
• Est. completion date: June 9, 2010

Study information

• Verified date: May 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 9, 2010
• Est. primary completion date: June 9, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Malondialdehyde
• Oxidative Stress
• Stroke

Intervention

Drug:
• Astaxanthine

• Placebo Oral Tablet

Locations

Country	Name	City	State
Indonesia	Department of Nutrition University of Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. Review. — View Citation

Demirkaya S, Topcuoglu MA, Aydin A, Ulas UH, Isimer AI, Vural O. Malondialdehyde, glutathione peroxidase and superoxide dismutase in peripheral blood erythrocytes of patients with acute cerebral ischemia. Eur J Neurol. 2001 Jan;8(1):43-51. — View Citation

Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998 Jul;74(873):395-9. Review. — View Citation

Hussein G, Nakamura M, Zhao Q, Iguchi T, Goto H, Sankawa U, Watanabe H. Antihypertensive and neuroprotective effects of astaxanthin in experimental animals. Biol Pharm Bull. 2005 Jan;28(1):47-52. — View Citation

Palozza P, Krinsky NI. Astaxanthin and canthaxanthin are potent antioxidants in a membrane model. Arch Biochem Biophys. 1992 Sep;297(2):291-5. — View Citation

Shen H, Kuo CC, Chou J, Delvolve A, Jackson SN, Post J, Woods AS, Hoffer BJ, Wang Y, Harvey BK. Astaxanthin reduces ischemic brain injury in adult rats. FASEB J. 2009 Jun;23(6):1958-68. doi: 10.1096/fj.08-123281. Epub 2009 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry	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).	7 days
Primary	National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients	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.	7 days